Cerebral Palsy
Conditions
Keywords
Trunk Stabilization Exercises, Oral Motor, Quality of Life, Communication
Brief summary
To investigate the effectiveness of neck and trunk stabilization exercises on communication and quality of life (QoL) in children with cerebral palsy (CP) with oral motor problems. Children with CP were randomly divided into Study Group (SG) and Control Group (CG). Neurodevelopmental treatment (NDT) approaches and oral motor therapy were applied to both groups. SG also received neck-trunk stabilization training.
Detailed description
In the multidisciplinary approach, special approaches to secondary problems, oral-motor trainings and communication studies are used in addition to Neurodevelopment treatment approach in the treatment of children with CP. Because of their impact on postural control, neck-trunk stabilization exercises are very important for therapeutic interventions designed to improve quality of life with activities of daily living. As the increases in neck muscle strength are related to trunk stabilization, trunk stabilization exercises are thought to have positive effects on neck muscle strength. In addition, since the neck and trunk are complementary to each other, it is supported by the literature that neck stabilization exercises and trunk stabilization exercises should be applied together.
Interventions
NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.
OTHERFeeding and oral-motor intervention strategies
Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.
OTHERNeck and trunk stabilization exercises
Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). All of these affect communication and quality of life.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Months to 54 Months
Healthy volunteers
No
Inclusion criteria
* 1.5 years and older, * Lack of cooperation problem to prevent communication, * To have been diagnosed with cerebral palsy and admitted to the hospital for routine control, * Volunteer to participate in the research, * Existence of at least one of the items of the Key Questions interrogation system showing feeding/swallowing problems in children with cerebral palsy.
Exclusion criteria
* Presence of severe vision and hearing loss, * Use any pharmacological agent to inhibit spasticity, * He/she had undergone orthopedic surgery or Botulinum Toxin-A injection in the last six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). | With VAS, families were asked to mark their communication status with their children. The definitions of the parameter to be evaluated are written on both ends of a 100 mm line. (0= no communication; 10= best communication). According to scale, the higher scores mean a better communication status |
| Katz Index of Independence in Activities of Daily Living (ADL) | Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). | Measures the capacity of a child to perform the activities that he/she has to do frequently in his/her daily life. The index has 6 questions. The patient gets 1 point if he/she makes each item independently; 0 points if he/she makes dependent. In the total score, 6 points indicate that patient is independent and 0 points indicate that patient is fully dependent. Higher Katz Index score means the better Activities of Daily Living. |
| Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) | Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). | It is a quality of life scale that measures health-related quality of life of children. It consists of 21 items. Items are scored between 0-100. The higher total score means a better health-related quality of life. |
| Short Form 36 Questionnaire (SF-36) | Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). | Quality of life of mothers was assessed by using the short form 36 questionnaire. It evaluates 8 sub-parameters, consisting of 36 items. 0= poor quality of life; 100= good quality of life. The higher score means a better health-related quality of life |
| Viking Speech Scale (VSS) | Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). | This scale has been developed to classify children's speech production. The scale has 4 levels. (Level 1= Speech is not affected by motor disorder; 4= No understandable speech). The low scores mean good speech production. |
| Gross Motor Function Classification System (GMFCS) | Immediately before the intervention, the evaluation was performed in the first session (only one time). | The gross motor function of children with cerebral palsy can be categorised into 5 different levels for the clear description of a child's current motor function. The higher level in GMFCS, means a worse and severe outcome. (Level I = Children walk without any limits; Level V= Children are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements). The low levels means good motor function. |
| Communication Function Classification System (CFCS) | Immediately before the intervention, an evaluation was performed in the first session (only one time). | CFCS provides 5 levels (CFCS I, II, III, IV, V) to describe everyday communication performance. The higher level in CFCS means a worse and severe outcome. Level 1= effective sender and receiver with unfamiliar and familiar partners; level 5=seldom effective sender and receiver even with familiar partners. Low levels mean good communication performance |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group (SG) In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.
Treatments were continued 2 days a week for 6 weeks (12 sessions).
Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.
Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.
Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). | 20 |
| Control Group (CG). (NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment.
Treatments were continued 2 days a week for 6 weeks (12 sessions).
Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.
Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Study Group (SG) | Control Group (CG). | Total |
|---|---|---|---|
| Age, Customized Age range (18-48 months) < | 13 Participants | 14 Participants | 27 Participants |
| Age, Customized Age range ≥ (48 months) | 7 Participants | 6 Participants | 13 Participants |
| Cerebral Palsy type diplegic | 3 Participants | 1 Participants | 4 Participants |
| Cerebral Palsy type dyskinetic | 1 Participants | 2 Participants | 3 Participants |
| Cerebral Palsy type hemiplegic | 2 Participants | 2 Participants | 4 Participants |
| Cerebral Palsy type hypotonic | 6 Participants | 5 Participants | 11 Participants |
| Cerebral Palsy type quadriplegic | 8 Participants | 10 Participants | 18 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Syria | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Turkey | 20 participants | 19 participants | 39 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Communication Function Classification System (CFCS)
CFCS provides 5 levels (CFCS I, II, III, IV, V) to describe everyday communication performance. The higher level in CFCS means a worse and severe outcome. Level 1= effective sender and receiver with unfamiliar and familiar partners; level 5=seldom effective sender and receiver even with familiar partners. Low levels mean good communication performance
Time frame: Immediately before the intervention, an evaluation was performed in the first session (only one time).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group (SG) | Communication Function Classification System (CFCS) | level 2 | 4 Participants |
| Study Group (SG) | Communication Function Classification System (CFCS) | level 4 | 4 Participants |
| Study Group (SG) | Communication Function Classification System (CFCS) | level 3 | 8 Participants |
| Study Group (SG) | Communication Function Classification System (CFCS) | level 5 | 3 Participants |
| Study Group (SG) | Communication Function Classification System (CFCS) | level 1 | 1 Participants |
| Control Group (CG). | Communication Function Classification System (CFCS) | level 5 | 8 Participants |
| Control Group (CG). | Communication Function Classification System (CFCS) | level 1 | 1 Participants |
| Control Group (CG). | Communication Function Classification System (CFCS) | level 2 | 3 Participants |
| Control Group (CG). | Communication Function Classification System (CFCS) | level 3 | 2 Participants |
| Control Group (CG). | Communication Function Classification System (CFCS) | level 4 | 6 Participants |
Primary
Gross Motor Function Classification System (GMFCS)
The gross motor function of children with cerebral palsy can be categorised into 5 different levels for the clear description of a child's current motor function. The higher level in GMFCS, means a worse and severe outcome. (Level I = Children walk without any limits; Level V= Children are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements). The low levels means good motor function.
Time frame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group (SG) | Gross Motor Function Classification System (GMFCS) | level 2 | 0 Participants |
| Study Group (SG) | Gross Motor Function Classification System (GMFCS) | level 4 | 4 Participants |
| Study Group (SG) | Gross Motor Function Classification System (GMFCS) | level 3 | 2 Participants |
| Study Group (SG) | Gross Motor Function Classification System (GMFCS) | level 5 | 10 Participants |
| Study Group (SG) | Gross Motor Function Classification System (GMFCS) | level 1 | 4 Participants |
| Control Group (CG). | Gross Motor Function Classification System (GMFCS) | level 5 | 14 Participants |
| Control Group (CG). | Gross Motor Function Classification System (GMFCS) | level 1 | 2 Participants |
| Control Group (CG). | Gross Motor Function Classification System (GMFCS) | level 2 | 0 Participants |
| Control Group (CG). | Gross Motor Function Classification System (GMFCS) | level 3 | 0 Participants |
| Control Group (CG). | Gross Motor Function Classification System (GMFCS) | level 4 | 4 Participants |
Primary
Katz Index of Independence in Activities of Daily Living (ADL)
Measures the capacity of a child to perform the activities that he/she has to do frequently in his/her daily life. The index has 6 questions. The patient gets 1 point if he/she makes each item independently; 0 points if he/she makes dependent. In the total score, 6 points indicate that patient is independent and 0 points indicate that patient is fully dependent. Higher Katz Index score means the better Activities of Daily Living.
Time frame: Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group (SG) | Katz Index of Independence in Activities of Daily Living (ADL) | 0.70 score on a scale | Standard Deviation 1.26 |
| Control Group (CG). | Katz Index of Independence in Activities of Daily Living (ADL) | 0.55 score on a scale | Standard Deviation 1.39 |
Primary
Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4)
It is a quality of life scale that measures health-related quality of life of children. It consists of 21 items. Items are scored between 0-100. The higher total score means a better health-related quality of life.
Time frame: Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group (SG) | Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) | 48.42 score on a scale | Standard Deviation 18.33 |
| Control Group (CG). | Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) | 53.48 score on a scale | Standard Deviation 20.28 |
Primary
Short Form 36 Questionnaire (SF-36)
Quality of life of mothers was assessed by using the short form 36 questionnaire. It evaluates 8 sub-parameters, consisting of 36 items. 0= poor quality of life; 100= good quality of life. The higher score means a better health-related quality of life
Time frame: Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group (SG) | Short Form 36 Questionnaire (SF-36) | 80.25 score on a scale | Standard Deviation 26.97 |
| Control Group (CG). | Short Form 36 Questionnaire (SF-36) | 81.75 score on a scale | Standard Deviation 17.93 |
Primary
Viking Speech Scale (VSS)
This scale has been developed to classify children's speech production. The scale has 4 levels. (Level 1= Speech is not affected by motor disorder; 4= No understandable speech). The low scores mean good speech production.
Time frame: Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Population: We applied this scale in 13 cases (7 in Study group and 6 in Control group). This scale can only be used for patients with SP in age of 4 and above. Therefore, these 13 cases were between the ages of 4-4.5 and provided sufficient age criteria to apply the scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group (SG) | Viking Speech Scale (VSS) | 3.14 score on a scale | Standard Deviation 1.06 |
| Control Group (CG). | Viking Speech Scale (VSS) | 3.50 score on a scale | Standard Deviation 0.837 |
Primary
Visual Analogue Scale (VAS)
With VAS, families were asked to mark their communication status with their children. The definitions of the parameter to be evaluated are written on both ends of a 100 mm line. (0= no communication; 10= best communication). According to scale, the higher scores mean a better communication status
Time frame: Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group (SG) | Visual Analogue Scale (VAS) | 6.75 units on a scale | Standard Deviation 3.1 |
| Control Group (CG). | Visual Analogue Scale (VAS) | 5.29 units on a scale | Standard Deviation 3.33 |