The Effects of Reaching Task Following Selective Trunk Stability Exercise

Not Applicable

Completed

• Conditions: Cerebral Stroke; Hemiplegia, Spastic
• Interventions: Behavioral: Abdominal drawing-in maneuver exercise; Behavioral: sham

• Registration Number: NCT05767437
• Lead Sponsor: University of Valencia

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.

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-14
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-10
• Results First Submitted: 2024-01-12
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Results First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)	sham	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.
Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise	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
Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise	sham	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, afterward Sham therapy(conventional physiotherapy)	Abdominal drawing-in maneuver exercise	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.

Primary Outcome Measures

Name	Time	Method
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
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_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.

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Ulsan National Institute of Science and Technology; 🇰🇷 Ulsan, Ulju, Korea, Republic of