Trial Outcomes & Findings for The Effects of Reaching Task Following Selective Trunk Stability Exercise (NCT NCT05767437)
NCT ID: NCT05767437
Last Updated: 2025-05-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline, two period(each 4weeks), wash out(4weeks)
Results posted on
2025-05-23
Participant Flow
4 participants dropped out during the washout period, leading to a smaller sample size and uneven group distribution in period 2.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Abdominal drawing-in Maneuver Exercise, Afterward Sham Therapy(Conventional Physiotherapy)
n=10 Participants
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
|
Sham Therapy(Conventional Physiotherapy), Afterward Abdominal drawing-in Maneuver Exercise
n=6 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=10 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=10 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=16 Participants
|
|
Age, Continuous
|
70.20 years
STANDARD_DEVIATION 10.05 • n=10 Participants
|
60.83 years
STANDARD_DEVIATION 10.55 • n=6 Participants
|
66.69 years
STANDARD_DEVIATION 10.94 • n=16 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Fugl-Meyer Assessment
|
36.90 scores on subscale
STANDARD_DEVIATION 15.47 • n=10 Participants
|
40.00 scores on subscale
STANDARD_DEVIATION 11.95 • n=6 Participants
|
38.06 scores on subscale
STANDARD_DEVIATION 13.91 • n=16 Participants
|
|
Onset
|
157.70 Months
STANDARD_DEVIATION 119.59 • n=10 Participants
|
142.00 Months
STANDARD_DEVIATION 78.16 • n=6 Participants
|
151.81 Months
STANDARD_DEVIATION 103.34 • n=16 Participants
|
|
Height
|
160.00 centimeter
STANDARD_DEVIATION 4.90 • n=10 Participants
|
164.58 centimeter
STANDARD_DEVIATION 7.93 • n=6 Participants
|
161.72 centimeter
STANDARD_DEVIATION 6.37 • n=16 Participants
|
|
Side of paralysis
Left
|
5 Participants
n=10 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
|
Side of paralysis
Right
|
5 Participants
n=10 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=16 Participants
|
|
Postural Assessment Scale for Stroke
|
33.30 units on a scale
STANDARD_DEVIATION 2.36 • n=10 Participants
|
30.33 units on a scale
STANDARD_DEVIATION 4.76 • n=6 Participants
|
32.19 units on a scale
STANDARD_DEVIATION 3.62 • n=16 Participants
|
|
Trunk Impairment Scale for stroke
|
14.40 units on a scale
STANDARD_DEVIATION 3.98 • n=10 Participants
|
14.50 units on a scale
STANDARD_DEVIATION 5.32 • n=6 Participants
|
14.44 units on a scale
STANDARD_DEVIATION 4.35 • n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline, two period(each 4weeks), wash out(4weeks)Population: Patients were randomly assigned to either Group A or Group B.
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
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation
|
304.97 Millimeter
Standard Deviation 83.22
|
303.34 Millimeter
Standard Deviation 45.74
|
PRIMARY outcome
Timeframe: Baseline, two period(each 4weeks), wash out(4weeks)Population: patients were randomly assigned to either Group A or Group B
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
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit
|
4.30 Number of movements
Standard Deviation 1.60
|
4.30 Number of movements
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: Baseline, two period(each 4weeks), wash out(4weeks)Population: Analysis population description: patients were randomly assigned to either Group A or Group B
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.
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle
|
127.43 degree on angle
Standard Deviation 25.23
|
134.13 degree on angle
Standard Deviation 13.89
|
SECONDARY outcome
Timeframe: Baseline, two period(each 4weeks), wash out(4weeks)Population: Analysis population description: patients were randomly assigned to either Group A or Group B
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
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
The Effect of a Particular Intervention During the Entire Course of the Study_Total Time
|
3.25 Second on time
Standard Deviation 0.78
|
3.06 Second on time
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline, two period(each 4weeks), wash out(4weeks)Population: Analysis population description: patients were randomly assigned to either Group A or Group B
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
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
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
|
934.48 Millimeter per second on time
Standard Deviation 560.00
|
SECONDARY outcome
Timeframe: Baseline, two period(each 4weeks), wash out(4weeks)Population: Analysis population description: patients were randomly assigned to either Group A or Group B
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.
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
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
|
41.98 Degree per second on time
Standard Deviation 27.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Analysis population description: patients were randomly assigned to either Group A or Group B
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)
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke
|
1 Score on a scale
Interval 0.0 to 2.0
|
1 Score on a scale
Interval 0.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Analysis population description: patients were randomly assigned to either Group A or Group B
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
Outcome measures
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 Participants
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 Participants
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
|
|---|---|---|
|
Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke
|
42.73 score on a subscale
Standard Deviation 18.94
|
49.36 score on a subscale
Standard Deviation 14.23
|
Adverse Events
Abdominal drawing-in Maneuver Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Therapy(Conventional Physiotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 participants at risk
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Other (Not including Serious) Adverse Events
|
0.00%
0/16 • 4 weeks after baseline measurement and after 4 weeks after period 2
Participants were monitored during exercise sessions for potential adverse events. Due to the nature of the basic abdominal exercises with conventional physiotherapy implemented in this study, no adverse events (including all-cause mortality, serious adverse events, or other adverse events) were observed or reported. The low-risk nature of the basic abdominal exercises with conventional physiotherapy contributed to this outcome. Adverse events were monitored/assessed, but none were observed
|
0.00%
0/16 • 4 weeks after baseline measurement and after 4 weeks after period 2
Participants were monitored during exercise sessions for potential adverse events. Due to the nature of the basic abdominal exercises with conventional physiotherapy implemented in this study, no adverse events (including all-cause mortality, serious adverse events, or other adverse events) were observed or reported. The low-risk nature of the basic abdominal exercises with conventional physiotherapy contributed to this outcome. Adverse events were monitored/assessed, but none were observed
|
Other adverse events
| Measure |
Abdominal drawing-in Maneuver Exercise
n=16 participants at risk
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
|
Sham Therapy(Conventional Physiotherapy)
n=16 participants at risk
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
|
|---|---|---|
|
Investigations
Temporal discomfort
|
0.00%
0/16 • 4 weeks after baseline measurement and after 4 weeks after period 2
Participants were monitored during exercise sessions for potential adverse events. Due to the nature of the basic abdominal exercises with conventional physiotherapy implemented in this study, no adverse events (including all-cause mortality, serious adverse events, or other adverse events) were observed or reported. The low-risk nature of the basic abdominal exercises with conventional physiotherapy contributed to this outcome. Adverse events were monitored/assessed, but none were observed
|
0.00%
0/16 • 4 weeks after baseline measurement and after 4 weeks after period 2
Participants were monitored during exercise sessions for potential adverse events. Due to the nature of the basic abdominal exercises with conventional physiotherapy implemented in this study, no adverse events (including all-cause mortality, serious adverse events, or other adverse events) were observed or reported. The low-risk nature of the basic abdominal exercises with conventional physiotherapy contributed to this outcome. Adverse events were monitored/assessed, but none were observed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place