Cerebral Stroke, Hemiplegia, Spastic
Conditions
Keywords
Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke
Brief summary
This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.
Detailed description
All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are Abdominal drawing-in maneuver exercise is following as: It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle. Conventional physiotherapy is following as: Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy. On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.
Interventions
BEHAVIORALAbdominal drawing-in maneuver exercise
From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising
BEHAVIORALsham
Release pain or upper limb mobilization
Sponsors
Ulsan National Institute of Science and Technology
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind.
Intervention model description
One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The subject consisted of the physician's confirmation of chronic hemiplegia * onset ≥ 6 months * Mini-mental state examination≥25 * Biceps ≤2, Triceps≤2 * Ability to Sit on a chair alone * FMA UE score ≥ 21points, FMA UE≤ 60 points
Exclusion criteria
* Biceps\>2, Triceps\>2 * Flaccid * Neglect syndrome * Have neurological disease and orthopedic disease * Lack of coordination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle | Baseline, two period(each 4weeks), wash out(4weeks) | We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10% Elbow angle in degree for reaching phase Participants who received that particular intervention during the entire course of the study. -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process. |
| The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit | Baseline, two period(each 4weeks), wash out(4weeks) | We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. It was defined by velocity peaks exceeding 20mm/s, with a minimum 150 ms interval. Participants who received that particular intervention during the entire course of the study. Number of movement units for reaching phase |
| The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation | Baseline, two period(each 4weeks), wash out(4weeks) | We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Effect of Abdominal Drawing-In Maneuver (AIDM) exercise and Shan therapy. Dislocation distance in millimeters(mm) for reaching phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity | Baseline, two period(each 4weeks), wash out(4weeks) | We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Peak angular velocity (rad/s) for the elbow were assessed during extension. |
| The Effect of a Particular Intervention During the Entire Course of the Study_Total Time | Baseline, two period(each 4weeks), wash out(4weeks) | We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Duration of time in second(s) for reaching phase |
| The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity | Baseline, two period(each 4weeks), wash out(4weeks) | We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. We analyzed peak hand velocity (mm/s) as velocity per unit time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke | Baseline | Scoring for Biceps and Triceps * MAS 0: No increase in tone * MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension. * MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) * MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed * MAS 3: considerable increase in tone, passive movement difficult * MAS 4: limb rigid in flexion or extension (MAS grade of 1 is equivalent to 1, whereas a MAS grade of 1+ includes grade of 2, 2-\>3, 3-\>4 in our study) |
| Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke | Baseline | Upper extremity(UE) Commonly used FMA-UE cutoff scores defined each category: 0 to 20 severe, 21 to 50 moderate, and 51 to 66 mild. * Shoulder, Elbow and Forearm 1. Reflex activity 2. Volitional movement within synergies 3. Volitional movement mixing synergies 4. Volitional movement with little or no synergy 5. Normal reflex activity * Wrist * Hand * Coordination/Speed Total score is 66 points |
Countries
South Korea
Participant flow
Pre-assignment details
4 participants dropped out during the washout period, leading to a smaller sample size and uneven group distribution in period 2.
Participants by arm
| Arm | Count |
|---|---|
| Abdominal drawing-in Maneuver Exercise, Afterward Sham Therapy(Conventional Physiotherapy) Participants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy\_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes.
Abdominal drawing-in maneuver exercise: From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising
sham: Release pain or upper limb mobilization | 10 |
| Sham Therapy(Conventional Physiotherapy), Afterward Abdominal drawing-in Maneuver Exercise Participants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy
Abdominal drawing-in maneuver exercise: From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising
sham: Release pain or upper limb mobilization | 6 |
| Total | 16 |
Baseline characteristics
| Characteristic | Abdominal drawing-in Maneuver Exercise, Afterward Sham Therapy(Conventional Physiotherapy) | Sham Therapy(Conventional Physiotherapy), Afterward Abdominal drawing-in Maneuver Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 2 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 70.20 years STANDARD_DEVIATION 10.05 | 60.83 years STANDARD_DEVIATION 10.55 | 66.69 years STANDARD_DEVIATION 10.94 |
| Fugl-Meyer Assessment | 36.90 scores on subscale STANDARD_DEVIATION 15.47 | 40.00 scores on subscale STANDARD_DEVIATION 11.95 | 38.06 scores on subscale STANDARD_DEVIATION 13.91 |
| Height | 160.00 centimeter STANDARD_DEVIATION 4.9 | 164.58 centimeter STANDARD_DEVIATION 7.93 | 161.72 centimeter STANDARD_DEVIATION 6.37 |
| Onset | 157.70 Months STANDARD_DEVIATION 119.59 | 142.00 Months STANDARD_DEVIATION 78.16 | 151.81 Months STANDARD_DEVIATION 103.34 |
| Postural Assessment Scale for Stroke | 33.30 units on a scale STANDARD_DEVIATION 2.36 | 30.33 units on a scale STANDARD_DEVIATION 4.76 | 32.19 units on a scale STANDARD_DEVIATION 3.62 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
| Side of paralysis Left | 5 Participants | 2 Participants | 7 Participants |
| Side of paralysis Right | 5 Participants | 4 Participants | 9 Participants |
| Trunk Impairment Scale for stroke | 14.40 units on a scale STANDARD_DEVIATION 3.98 | 14.50 units on a scale STANDARD_DEVIATION 5.32 | 14.44 units on a scale STANDARD_DEVIATION 4.35 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10% Elbow angle in degree for reaching phase Participants who received that particular intervention during the entire course of the study. -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Population: Analysis population description: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle | 127.43 degree on angle | Standard Deviation 25.23 |
| Sham Therapy(Conventional Physiotherapy) | The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle | 134.13 degree on angle | Standard Deviation 13.89 |
p-value: 0.6895% CI: [-24.12, 10.71]Mixed Models Analysis
Primary
The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. It was defined by velocity peaks exceeding 20mm/s, with a minimum 150 ms interval. Participants who received that particular intervention during the entire course of the study. Number of movement units for reaching phase
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Population: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit | 4.30 Number of movements | Standard Deviation 1.6 |
| Sham Therapy(Conventional Physiotherapy) | The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit | 4.30 Number of movements | Standard Deviation 1.39 |
p-value: 0.9995% CI: [-1.25, 1.24]Mixed Models Analysis
Primary
The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Effect of Abdominal Drawing-In Maneuver (AIDM) exercise and Shan therapy. Dislocation distance in millimeters(mm) for reaching phase
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Population: Patients were randomly assigned to either Group A or Group B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation | 304.97 Millimeter | Standard Deviation 83.22 |
| Sham Therapy(Conventional Physiotherapy) | The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation | 303.34 Millimeter | Standard Deviation 45.74 |
p-value: 0.9895% CI: [-55.79, 59.05]Mixed Models Analysis
Secondary
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Peak angular velocity (rad/s) for the elbow were assessed during extension.
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Population: Analysis population description: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity | 54.23 Degree per second on time | Standard Deviation 50.83 |
| Sham Therapy(Conventional Physiotherapy) | The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity | 41.98 Degree per second on time | Standard Deviation 27.79 |
p-value: 0.4595% CI: [-18.67, 43.17]Mixed Models Analysis
Secondary
The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. We analyzed peak hand velocity (mm/s) as velocity per unit time
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Population: Analysis population description: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity | 684.13 Millimeter per second on time | Standard Deviation 339.62 |
| Sham Therapy(Conventional Physiotherapy) | The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity | 934.48 Millimeter per second on time | Standard Deviation 560 |
p-value: 0.4295% CI: [-614.88, 114.18]Mixed Models Analysis
Secondary
The Effect of a Particular Intervention During the Entire Course of the Study_Total Time
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Duration of time in second(s) for reaching phase
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Population: Analysis population description: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | The Effect of a Particular Intervention During the Entire Course of the Study_Total Time | 3.25 Second on time | Standard Deviation 0.78 |
| Sham Therapy(Conventional Physiotherapy) | The Effect of a Particular Intervention During the Entire Course of the Study_Total Time | 3.06 Second on time | Standard Deviation 0.88 |
Comparison: an effect size of 0.24, α \< 0.05, power = 24.5p-value: 0.5695% CI: [-0.48, 0.87]Mixed Models Analysis
Other Pre-specified
Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke
Upper extremity(UE) Commonly used FMA-UE cutoff scores defined each category: 0 to 20 severe, 21 to 50 moderate, and 51 to 66 mild. * Shoulder, Elbow and Forearm 1. Reflex activity 2. Volitional movement within synergies 3. Volitional movement mixing synergies 4. Volitional movement with little or no synergy 5. Normal reflex activity * Wrist * Hand * Coordination/Speed Total score is 66 points
Time frame: Baseline
Population: Analysis population description: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal drawing-in Maneuver Exercise | Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke | 42.73 score on a subscale | Standard Deviation 18.94 |
| Sham Therapy(Conventional Physiotherapy) | Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke | 49.36 score on a subscale | Standard Deviation 14.23 |
p-value: 0.3895% CI: [-19.38, 6.12]t-test, 2 sided
Other Pre-specified
Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke
Scoring for Biceps and Triceps * MAS 0: No increase in tone * MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension. * MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) * MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed * MAS 3: considerable increase in tone, passive movement difficult * MAS 4: limb rigid in flexion or extension (MAS grade of 1 is equivalent to 1, whereas a MAS grade of 1+ includes grade of 2, 2-\>3, 3-\>4 in our study)
Time frame: Baseline
Population: Analysis population description: patients were randomly assigned to either Group A or Group B
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abdominal drawing-in Maneuver Exercise | Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke | 1 Score on a scale |
| Sham Therapy(Conventional Physiotherapy) | Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke | 1 Score on a scale |
p-value: 0.6795% CI: [-0.61, 0.96]Wilcoxon (Mann-Whitney)