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Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

Effects of Hippotherapy on Physical Activities, Cardiopulmonary Fitness and Attention in Children With Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03870893
Enrollment
47
Registered
2019-03-12
Start date
2017-07-05
Completion date
2020-02-28
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Disorder, Cerebral Palsy, Physical Activity

Keywords

cerebral palsy, hippotherapy, cardiopulmonary fitness, physical activity, attention

Brief summary

This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

Detailed description

This research aims to promote hippotherapy by scientifically proving its therapeutic effects and mechanism to contribute to improving the health and quality of life of the patients as well as reducing their global burden of disease by shifting the current passive therapy-oriented paradigm to a more proactive participation-oriented paradigm. Ever since physical activity and physical fitness have been reported to have an inverse relationship with the mortality rate, especially deaths due to cardiovascular disease, various efforts have been made to optimize physical activity and physical fitness among children with cerebral palsy. ADHD is one of the most common coexisting conditions of cerebral palsy. More participation in engaging sports activities like therapeutic riding is anticipated to improve patient health and their quality of life. Hippotherapy is expected to improve clinical symptom of ADHD in children with cerebral palsy while preventing possible ensuing psychiatric disorders, thereby bringing significant improvement in their health and quality of life.

Interventions

BEHAVIORALhippotherapy

16weeks hippotherapy program

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of spastic CP * GMFCS level I-III * weight \< 35kg * ability to walk independently with or without an assistive device * ability to comply with the study protocol and follow verbal directions

Exclusion criteria

* botulinum toxin injection within 3 months * orthopedic surgery within 1 year (difficulty performing one step instructions) * moderate to severe intellectual disability * uncontrolled seizure * poor visual or hearing acuity * patients who weigh more than 35 kg * hip dislocation * scoliosis more than 30 degrees * musculoskeletal surgery within 1 year

Design outcomes

Primary

MeasureTime frameDescription
Change of Clinical Global Improvement(CGI)Change in baseline CGI at 16weeksThe Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.

Secondary

MeasureTime frameDescription
Change of Physical Activity(%)Change in baseline physical activity at 16weeksThe %sedentary physical activity(%SPA), %light physical activity(%LPA), %moderate physical activity(%MPA), %vigorous physical activity(%VPA) during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA).
Change of Peak Oxygen Uptake(VO2peak)Change in baseline peak oxygen uptake at 16weekspeak oxygen uptake(ml/kg/min) is a category of physical fitness, which is measured during graded submaximal exercise test. Higher values represent a better outcome.
Change of Gross Motor Function Measure 66Change in baseline Gross Motor Function Measure 66 at 16weeksGMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or not tested. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score in GMFM-66 is from 0 to 100. The range of % in GMFM-88 is from 0 to 100. Higher values represent a better outcome.
Change of Physical Activity(Steps)Change in baseline steps at 16weeksSteps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)
Change of Resting Heart Rate(RHR)Change in baseline resting heart rate at 16weeksResting heart rate(beats/min) is a category of physical fitness, which is measured during graded submaximal exercise test. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.
Change of Respiratory Exchange Ratio(RER)Change in baseline respiratory exchange ratio at 16weeksAll patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. Respiratory exchange ratio(RER) were measured with a gas analyzer. RER is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used. A high RER (RER values≥1) indicates that carbohydrates are being predominantly used, whereas a low RER (RER values\<1) suggests lipid oxidation.
Change of Heart Rate Recovery(HRR)Change in baseline heart rate recovery at 16weeksAll patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. In the recovery period, the patients walked for 2 minutes at a speed of 1.9 km/h and a grade of 0% and then sat down in a chair for the last 3 minutes (recovery). The Heart rate recovery (HRR) was defined as the difference between peak HR during the test and HR at 1 (HRR1), 3 (HRR3), and 5 (HRR5) minutes.
Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)Change in baseline child health questionnaire-parent form 50 at 16weeksThe Child Health Questionnaire™ (CHQ) is a family of generic person-reported outcomes measures to assess health-related quality of life for children and adolescents from 5-to-18 years of age. Child Health Questionnaire Parent Form 50 (CHQ-PF50) Questions; total 50 questions, 4 or 6 score Likert scale, the score range is from 0 to 100, higher values represent a better outcome. Scores can be analyzed at combined to derive an overall physical and psychosocial score, (CHQ Summary Scores).
Change of AttentionChange in baseline attention at 16weeksChild Behavior Checklist; The Social Ability Scale consists of Sociality Scale and Academic Performance Scale. The Scale of Problem Behavior Syndrome consists of 113 items related to problem behavior, and 13 (Sociality, Learning Problem, Total Social Ability, Atrophy, Depression, social immaturity, thinking problems, attention problems, flying, aggression, internalization problems, externalizing problems, total problem behaviors). For each question, the scale is to be rated as 3-point Likert scale, the raw scores of all subscales are converted to standardized T scores . The higher the score, the higher the tendency toward problem behavior.
Change of 6 Minute Walk Test(6MWT)Change in baseline 6 minute walk test at 16weeksThe 6 minute walk test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance. Higher values represent a better outcome.
Change of Blood Pressure(BP)Change in baseline blood pressure at 16weeksBlood pressure(mmHg) measured before graded exercise test using treadmill.
Change of Pediatric Balance Scale(PBS)Change in baseline pediatric balance scale at 16weeksPBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS has been used initially to measure the balance functions for school-age children with mild-to-moderate motor impairments. The PBS is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The range of total score is from 0 to 56. Higher values represent a better outcome.
Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating ScaleChange in baseline ADHD rating scale at 16weeksADHD(attention deficit hyperactivity disorder) rating scale; total 18 questions. Each item is scored from 0-3 points, The treatment effect is evaluated using Total score(0 \ 54 points),attention-deficit scores (0 \ 27 points) and hyperactivity/impulsivity score (0 \ 27 points)
Change of Self-Esteem ScaleChange in baseline self-esteem at 16weeksSelf-Esteem Scale; total 10 question, Each item is scored from 1-4 points. Five of the ten questions are positive and five are negative. In the positive item, 1 = 'almost not so' and 4 = 'always'. In the negative item, the scores range from 10 to 40. The treatment effect is evaluated using the total score.
Change of PedsQL 4.0Change in baseline quality life of child at 16weeksPedsQL 4.0; total 23 questions; Each item is scored from 0-4 points and scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Thus, the scores range from 0 to 2300, higher values represent a better outcome.
Change of Continuous Performance Test 3rd EditionChange in baseline attention at 16weeksContinuous Performance Test 3rd edition; It is a computerized assessment tool designed to measure attention-related problems, instructing them to respond to all stimuli except alphabet X, and instructing them to perform as accurately and quickly as possible. Detectability, Omission Errors, Commission Errors, Perseverations, HRT(hit reaction time), HRT SD (standard deviation), Variability, HRT Block Change, HRT ISI Change are used to assess respondents' performance on inattentiveness, impulsivity, sustained attention, and vigilance. It is used 9 T-scores to assess the level of attention problem.
Change of Quantitative ElectroencephalographyChange in baseline Quantitative electroencephalography at 16weeksAn electroencephalogram (EEG) is a test that detects electrical activity in your brain using small, metal discs(electrodes) attached to your scalp. Your brain cells communicate via electrical impulses and are active all the time. This activity shows up as wave lines on an EEG recording. It is using Neuroscan Synamp2 amplifier(Compumedics USA, El Paso, TX, USA). For quantitative analysis, EEG without a handwriting is digitized by Fast Fourier Transformation. The square root of the magnitude of the EEG was calculated as the microvolt (uV) value, and the relative power is defined as the electrical force of the specific region divided by the electrical force in the whole region. The relative power of delta, theta, alpha, and beta waves and theta/beta ratio measured at the Fz, Cz, Pz electrode are used for the analysis. The value of theta/beta ratio is average as it approaches 0 and deviates from the mean as it gets away from 0.
Change of Timed up and go(TUG)Change in baseline timed up and go at 16weeks① Stand up from the chair without support. ② Walk 3m from chair. ③ Turn around. ④ Sit back in the chair. Measure the time(second), higher values represent a worse outcome. Lower values represent a better outcome.

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Intervention Group
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
23
Control Group
No intervention
23
Total46

Baseline characteristics

CharacteristicControl GroupTotalIntervention Group
Age, Categorical
<=18 years
23 Participants46 Participants23 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous7.22 years
STANDARD_DEVIATION 1.48
7.48 years
STANDARD_DEVIATION 1.56
7.74 years
STANDARD_DEVIATION 1.63
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
23 Participants46 Participants23 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Korea
23 participants46 participants23 participants
Sex: Female, Male
Female
11 Participants22 Participants11 Participants
Sex: Female, Male
Male
12 Participants24 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 23
other
Total, other adverse events
0 / 230 / 23
serious
Total, serious adverse events
0 / 230 / 23

Outcome results

Primary

Change of Clinical Global Improvement(CGI)

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.

Time frame: Change in baseline CGI at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Clinical Global Improvement(CGI)Change of CGI-S-0.13 score on a scaleStandard Deviation 0.46
Intervention GroupChange of Clinical Global Improvement(CGI)Change of CGI-I2.65 score on a scaleStandard Deviation 0.78
Control GroupChange of Clinical Global Improvement(CGI)Change of CGI-S-0.09 score on a scaleStandard Deviation 0.29
Control GroupChange of Clinical Global Improvement(CGI)Change of CGI-I3.87 score on a scaleStandard Deviation 0.46
Secondary

Change of 6 Minute Walk Test(6MWT)

The 6 minute walk test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance. Higher values represent a better outcome.

Time frame: Change in baseline 6 minute walk test at 16weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of 6 Minute Walk Test(6MWT)37.22 metersStandard Deviation 49.52
Control GroupChange of 6 Minute Walk Test(6MWT)13.43 metersStandard Deviation 37.47
Secondary

Change of Attention

Child Behavior Checklist; The Social Ability Scale consists of Sociality Scale and Academic Performance Scale. The Scale of Problem Behavior Syndrome consists of 113 items related to problem behavior, and 13 (Sociality, Learning Problem, Total Social Ability, Atrophy, Depression, social immaturity, thinking problems, attention problems, flying, aggression, internalization problems, externalizing problems, total problem behaviors). For each question, the scale is to be rated as 3-point Likert scale, the raw scores of all subscales are converted to standardized T scores . The higher the score, the higher the tendency toward problem behavior.

Time frame: Change in baseline attention at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of AttentionTotal problems(pre)57.52 T-scoreStandard Deviation 9.08
Intervention GroupChange of AttentionTotal problems(post)54.61 T-scoreStandard Deviation 11.63
Control GroupChange of AttentionTotal problems(pre)57.70 T-scoreStandard Deviation 7.15
Control GroupChange of AttentionTotal problems(post)55.39 T-scoreStandard Deviation 7.55
Secondary

Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale

ADHD(attention deficit hyperactivity disorder) rating scale; total 18 questions. Each item is scored from 0-3 points, The treatment effect is evaluated using Total score(0 \ 54 points),attention-deficit scores (0 \ 27 points) and hyperactivity/impulsivity score (0 \ 27 points)

Time frame: Change in baseline ADHD rating scale at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Attention Deficit Hyperactivity Disorder (ADHD) Rating ScaleTotal score(pre)12.22 score on a scaleStandard Deviation 8.66
Intervention GroupChange of Attention Deficit Hyperactivity Disorder (ADHD) Rating ScaleTotal score(post)11.17 score on a scaleStandard Deviation 8.32
Control GroupChange of Attention Deficit Hyperactivity Disorder (ADHD) Rating ScaleTotal score(pre)11.13 score on a scaleStandard Deviation 8.32
Control GroupChange of Attention Deficit Hyperactivity Disorder (ADHD) Rating ScaleTotal score(post)10.26 score on a scaleStandard Deviation 8.2
Secondary

Change of Blood Pressure(BP)

Blood pressure(mmHg) measured before graded exercise test using treadmill.

Time frame: Change in baseline blood pressure at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Blood Pressure(BP)Change of SBP-1.30 mmHgStandard Deviation 7.03
Intervention GroupChange of Blood Pressure(BP)Change of DBP-1.55 mmHgStandard Deviation 8.22
Control GroupChange of Blood Pressure(BP)Change of SBP0.05 mmHgStandard Deviation 6.29
Control GroupChange of Blood Pressure(BP)Change of DBP0.52 mmHgStandard Deviation 7.73
Secondary

Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)

The Child Health Questionnaire™ (CHQ) is a family of generic person-reported outcomes measures to assess health-related quality of life for children and adolescents from 5-to-18 years of age. Child Health Questionnaire Parent Form 50 (CHQ-PF50) Questions; total 50 questions, 4 or 6 score Likert scale, the score range is from 0 to 100, higher values represent a better outcome. Scores can be analyzed at combined to derive an overall physical and psychosocial score, (CHQ Summary Scores).

Time frame: Change in baseline child health questionnaire-parent form 50 at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Children Health Questionnaire Parent Form 50 (CHQ-PF50)Summary score(Physical)2.73 score on a scaleStandard Deviation 7.42
Intervention GroupChange of Children Health Questionnaire Parent Form 50 (CHQ-PF50)Summary score(Psychosocial)3.31 score on a scaleStandard Deviation 7.78
Control GroupChange of Children Health Questionnaire Parent Form 50 (CHQ-PF50)Summary score(Physical)2.08 score on a scaleStandard Deviation 7.78
Control GroupChange of Children Health Questionnaire Parent Form 50 (CHQ-PF50)Summary score(Psychosocial)2.50 score on a scaleStandard Deviation 6.65
Secondary

Change of Continuous Performance Test 3rd Edition

Continuous Performance Test 3rd edition; It is a computerized assessment tool designed to measure attention-related problems, instructing them to respond to all stimuli except alphabet X, and instructing them to perform as accurately and quickly as possible. Detectability, Omission Errors, Commission Errors, Perseverations, HRT(hit reaction time), HRT SD (standard deviation), Variability, HRT Block Change, HRT ISI Change are used to assess respondents' performance on inattentiveness, impulsivity, sustained attention, and vigilance. It is used 9 T-scores to assess the level of attention problem.

Time frame: Change in baseline attention at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Continuous Performance Test 3rd Editionhit reaction time(post)70.04 T-scoresStandard Deviation 14.22
Intervention GroupChange of Continuous Performance Test 3rd EditionPerseveration(pre)61.30 T-scoresStandard Deviation 13.65
Intervention GroupChange of Continuous Performance Test 3rd EditionOmissions(post)67.13 T-scoresStandard Deviation 18.61
Intervention GroupChange of Continuous Performance Test 3rd EditionPerseveration(post)53.04 T-scoresStandard Deviation 8.22
Intervention GroupChange of Continuous Performance Test 3rd Editiondetectability(post)52.57 T-scoresStandard Deviation 10.23
Intervention GroupChange of Continuous Performance Test 3rd Editionhit reaction time(pre)69.87 T-scoresStandard Deviation 14.75
Intervention GroupChange of Continuous Performance Test 3rd EditionCommisions(pre)48.74 T-scoresStandard Deviation 9.9
Intervention GroupChange of Continuous Performance Test 3rd Editiondetectability(pre)59.00 T-scoresStandard Deviation 7.62
Intervention GroupChange of Continuous Performance Test 3rd Editionstandard deviation of hit reaction time(pre)65.74 T-scoresStandard Deviation 12.08
Intervention GroupChange of Continuous Performance Test 3rd EditionCommisions(post)42.96 T-scoresStandard Deviation 7.5
Intervention GroupChange of Continuous Performance Test 3rd Editionstandard deviation of hit reaction time(post)60.78 T-scoresStandard Deviation 12.14
Intervention GroupChange of Continuous Performance Test 3rd EditionOmissions(pre)71.70 T-scoresStandard Deviation 16.66
Control GroupChange of Continuous Performance Test 3rd Editionstandard deviation of hit reaction time(post)55.04 T-scoresStandard Deviation 9.77
Control GroupChange of Continuous Performance Test 3rd Editiondetectability(pre)54.00 T-scoresStandard Deviation 7.76
Control GroupChange of Continuous Performance Test 3rd Editiondetectability(post)49.61 T-scoresStandard Deviation 8.11
Control GroupChange of Continuous Performance Test 3rd EditionOmissions(pre)59.91 T-scoresStandard Deviation 11.29
Control GroupChange of Continuous Performance Test 3rd EditionOmissions(post)57.91 T-scoresStandard Deviation 14.84
Control GroupChange of Continuous Performance Test 3rd EditionCommisions(pre)46.65 T-scoresStandard Deviation 9.47
Control GroupChange of Continuous Performance Test 3rd EditionCommisions(post)43.13 T-scoresStandard Deviation 7.24
Control GroupChange of Continuous Performance Test 3rd EditionPerseveration(pre)51.57 T-scoresStandard Deviation 8.77
Control GroupChange of Continuous Performance Test 3rd EditionPerseveration(post)49.91 T-scoresStandard Deviation 6.82
Control GroupChange of Continuous Performance Test 3rd Editionhit reaction time(pre)65.04 T-scoresStandard Deviation 11.31
Control GroupChange of Continuous Performance Test 3rd Editionhit reaction time(post)65.70 T-scoresStandard Deviation 12.31
Control GroupChange of Continuous Performance Test 3rd Editionstandard deviation of hit reaction time(pre)55.83 T-scoresStandard Deviation 10.18
Secondary

Change of Gross Motor Function Measure 66

GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or not tested. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score in GMFM-66 is from 0 to 100. The range of % in GMFM-88 is from 0 to 100. Higher values represent a better outcome.

Time frame: Change in baseline Gross Motor Function Measure 66 at 16weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Gross Motor Function Measure 662.24 scores on a scaleStandard Deviation 2.32
Control GroupChange of Gross Motor Function Measure 660.81 scores on a scaleStandard Deviation 0.97
Secondary

Change of Heart Rate Recovery(HRR)

All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. In the recovery period, the patients walked for 2 minutes at a speed of 1.9 km/h and a grade of 0% and then sat down in a chair for the last 3 minutes (recovery). The Heart rate recovery (HRR) was defined as the difference between peak HR during the test and HR at 1 (HRR1), 3 (HRR3), and 5 (HRR5) minutes.

Time frame: Change in baseline heart rate recovery at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Heart Rate Recovery(HRR)Change of heart rate recovery 16.54 beats per minuteStandard Deviation 6.34
Intervention GroupChange of Heart Rate Recovery(HRR)Change of heart rate recovery313.38 beats per minuteStandard Deviation 12.92
Intervention GroupChange of Heart Rate Recovery(HRR)Change of heart rate recovery511.15 beats per minuteStandard Deviation 11.42
Control GroupChange of Heart Rate Recovery(HRR)Change of heart rate recovery 1-2.15 beats per minuteStandard Deviation 5.2
Control GroupChange of Heart Rate Recovery(HRR)Change of heart rate recovery3-5.54 beats per minuteStandard Deviation 5.81
Control GroupChange of Heart Rate Recovery(HRR)Change of heart rate recovery5-3.80 beats per minuteStandard Deviation 7.07
Secondary

Change of Peak Oxygen Uptake(VO2peak)

peak oxygen uptake(ml/kg/min) is a category of physical fitness, which is measured during graded submaximal exercise test. Higher values represent a better outcome.

Time frame: Change in baseline peak oxygen uptake at 16weeks

Population: Five Participants want to stop during measurement (Intervention group -\> 3 participants; Control group -\> 2 participants)

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Peak Oxygen Uptake(VO2peak)1.84 ml/kg/minStandard Deviation 4.33
Control GroupChange of Peak Oxygen Uptake(VO2peak)-0.09 ml/kg/minStandard Deviation 3.57
Secondary

Change of Pediatric Balance Scale(PBS)

PBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS has been used initially to measure the balance functions for school-age children with mild-to-moderate motor impairments. The PBS is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The range of total score is from 0 to 56. Higher values represent a better outcome.

Time frame: Change in baseline pediatric balance scale at 16weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Pediatric Balance Scale(PBS)2.48 score on a scaleStandard Deviation 2
Control GroupChange of Pediatric Balance Scale(PBS)0.30 score on a scaleStandard Deviation 0.88
Secondary

Change of PedsQL 4.0

PedsQL 4.0; total 23 questions; Each item is scored from 0-4 points and scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Thus, the scores range from 0 to 2300, higher values represent a better outcome.

Time frame: Change in baseline quality life of child at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of PedsQL 4.0Physical functioning(pre)60.73 score on a scaleStandard Deviation 19.21
Intervention GroupChange of PedsQL 4.0Physical functioning(post)69.70 score on a scaleStandard Deviation 15.81
Intervention GroupChange of PedsQL 4.0Emotional functioning(pre)70.22 score on a scaleStandard Deviation 24.84
Intervention GroupChange of PedsQL 4.0Emotional functioning(post)79.13 score on a scaleStandard Deviation 20.49
Intervention GroupChange of PedsQL 4.0Social functioning(pre)58.48 score on a scaleStandard Deviation 28.14
Intervention GroupChange of PedsQL 4.0Social functioning(post)74.13 score on a scaleStandard Deviation 16.9
Intervention GroupChange of PedsQL 4.0School functioning(pre)69.35 score on a scaleStandard Deviation 22.98
Intervention GroupChange of PedsQL 4.0School functioning(post)74.13 score on a scaleStandard Deviation 18.99
Control GroupChange of PedsQL 4.0School functioning(post)85.44 score on a scaleStandard Deviation 12.33
Control GroupChange of PedsQL 4.0Physical functioning(pre)65.90 score on a scaleStandard Deviation 18.15
Control GroupChange of PedsQL 4.0Social functioning(pre)61.30 score on a scaleStandard Deviation 27019
Control GroupChange of PedsQL 4.0Physical functioning(post)77.85 score on a scaleStandard Deviation 15.1
Control GroupChange of PedsQL 4.0School functioning(pre)72.39 score on a scaleStandard Deviation 24.67
Control GroupChange of PedsQL 4.0Emotional functioning(pre)69.57 score on a scaleStandard Deviation 27.67
Control GroupChange of PedsQL 4.0Social functioning(post)80.65 score on a scaleStandard Deviation 22.02
Control GroupChange of PedsQL 4.0Emotional functioning(post)82.17 score on a scaleStandard Deviation 16.98
Secondary

Change of Physical Activity(%)

The %sedentary physical activity(%SPA), %light physical activity(%LPA), %moderate physical activity(%MPA), %vigorous physical activity(%VPA) during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA).

Time frame: Change in baseline physical activity at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Physical Activity(%)Change of %LPA-1.58 percentage of physcal activityStandard Deviation 4.41
Intervention GroupChange of Physical Activity(%)Change of %VPA0.00 percentage of physcal activityStandard Deviation 0.53
Intervention GroupChange of Physical Activity(%)Change of %SPA1.86 percentage of physcal activityStandard Deviation 5.07
Intervention GroupChange of Physical Activity(%)Change of %MPA-0.28 percentage of physcal activityStandard Deviation 0.67
Control GroupChange of Physical Activity(%)Change of %VPA0.25 percentage of physcal activityStandard Deviation 0.75
Control GroupChange of Physical Activity(%)Change of %LPA0.24 percentage of physcal activityStandard Deviation 3.74
Control GroupChange of Physical Activity(%)Change of %MPA0.13 percentage of physcal activityStandard Deviation 1
Control GroupChange of Physical Activity(%)Change of %SPA-0.61 percentage of physcal activityStandard Deviation 4.86
Secondary

Change of Physical Activity(Steps)

Steps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)

Time frame: Change in baseline steps at 16weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Physical Activity(Steps)-37.97 step counts per minuteStandard Deviation 140.5
Control GroupChange of Physical Activity(Steps)20.94 step counts per minuteStandard Deviation 180.53
Secondary

Change of Quantitative Electroencephalography

An electroencephalogram (EEG) is a test that detects electrical activity in your brain using small, metal discs(electrodes) attached to your scalp. Your brain cells communicate via electrical impulses and are active all the time. This activity shows up as wave lines on an EEG recording. It is using Neuroscan Synamp2 amplifier(Compumedics USA, El Paso, TX, USA). For quantitative analysis, EEG without a handwriting is digitized by Fast Fourier Transformation. The square root of the magnitude of the EEG was calculated as the microvolt (uV) value, and the relative power is defined as the electrical force of the specific region divided by the electrical force in the whole region. The relative power of delta, theta, alpha, and beta waves and theta/beta ratio measured at the Fz, Cz, Pz electrode are used for the analysis. The value of theta/beta ratio is average as it approaches 0 and deviates from the mean as it gets away from 0.

Time frame: Change in baseline Quantitative electroencephalography at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Quantitative ElectroencephalographyFz(pre)0.384 Z-scoreStandard Deviation 0.961
Intervention GroupChange of Quantitative ElectroencephalographyFz(post)0.522 Z-scoreStandard Deviation 0.835
Intervention GroupChange of Quantitative ElectroencephalographyCz(pre)0.501 Z-scoreStandard Deviation 1.42
Intervention GroupChange of Quantitative ElectroencephalographyCz(post)0.274 Z-scoreStandard Deviation 0.933
Intervention GroupChange of Quantitative ElectroencephalographyPz(pre)0.077 Z-scoreStandard Deviation 0.857
Intervention GroupChange of Quantitative ElectroencephalographyPz(post)0.240 Z-scoreStandard Deviation 1.141
Control GroupChange of Quantitative ElectroencephalographyPz(pre)-0.130 Z-scoreStandard Deviation 0.98
Control GroupChange of Quantitative ElectroencephalographyFz(pre)-0.046 Z-scoreStandard Deviation 0.91
Control GroupChange of Quantitative ElectroencephalographyCz(post)0.342 Z-scoreStandard Deviation 0.76
Control GroupChange of Quantitative ElectroencephalographyFz(post)-0.098 Z-scoreStandard Deviation 0.826
Control GroupChange of Quantitative ElectroencephalographyPz(post)-0.156 Z-scoreStandard Deviation 0.73
Control GroupChange of Quantitative ElectroencephalographyCz(pre)0.058 Z-scoreStandard Deviation 0.883
Secondary

Change of Respiratory Exchange Ratio(RER)

All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. Respiratory exchange ratio(RER) were measured with a gas analyzer. RER is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used. A high RER (RER values≥1) indicates that carbohydrates are being predominantly used, whereas a low RER (RER values\<1) suggests lipid oxidation.

Time frame: Change in baseline respiratory exchange ratio at 16weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Respiratory Exchange Ratio(RER)0.04 RatioStandard Deviation 0.05
Control GroupChange of Respiratory Exchange Ratio(RER)0.01 RatioStandard Deviation 0.05
Secondary

Change of Resting Heart Rate(RHR)

Resting heart rate(beats/min) is a category of physical fitness, which is measured during graded submaximal exercise test. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.

Time frame: Change in baseline resting heart rate at 16weeks

Population: Participants want to stop during measurement (Intervention group -\> 3 participants; Control group -\> 2 participants)

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Resting Heart Rate(RHR)-12.40 beats per minuteStandard Deviation 11.98
Control GroupChange of Resting Heart Rate(RHR)-0.62 beats per minuteStandard Deviation 8.41
Secondary

Change of Self-Esteem Scale

Self-Esteem Scale; total 10 question, Each item is scored from 1-4 points. Five of the ten questions are positive and five are negative. In the positive item, 1 = 'almost not so' and 4 = 'always'. In the negative item, the scores range from 10 to 40. The treatment effect is evaluated using the total score.

Time frame: Change in baseline self-esteem at 16weeks

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange of Self-Esteem ScalePre-test outcome31.22 score on a scaleStandard Deviation 4.34
Intervention GroupChange of Self-Esteem ScalePost-test outcome32.35 score on a scaleStandard Deviation 3.61
Control GroupChange of Self-Esteem ScalePre-test outcome32.48 score on a scaleStandard Deviation 2.81
Control GroupChange of Self-Esteem ScalePost-test outcome33.34 score on a scaleStandard Deviation 3.72
Secondary

Change of Timed up and go(TUG)

① Stand up from the chair without support. ② Walk 3m from chair. ③ Turn around. ④ Sit back in the chair. Measure the time(second), higher values represent a worse outcome. Lower values represent a better outcome.

Time frame: Change in baseline timed up and go at 16weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange of Timed up and go(TUG)-1.55 secondsStandard Deviation 1.19
Control GroupChange of Timed up and go(TUG)-1.33 secondsStandard Deviation 3.64

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026