| CTRI Number |
CTRI/2025/11/097112 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of activity based arm exercise on affected arm recovery and arm usage in post individuals with arm paralysis |
|
Scientific Title of Study
|
Effectiveness and Adherence to a task oriented home exercise program on upper limb motor recovery and functional arm usage in individuals with subacute Middle Cerebral Artery Stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthana C |
| Designation |
Post graduate student |
| Affiliation |
KMCH College of Physiotherapy.The Tamilnadu Dr M G R Medical University |
| Address |
Room number - 019 Department of Advanced PT in Neurology KMCH College of Physiotherapy, Affiliated to The Tamilnadu Dr M G R Medical University, Kalapatti Road Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9095366192 |
| Fax |
|
| Email |
ckeerthi987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Brammatha A |
| Designation |
Professor |
| Affiliation |
KMCH College of Physiotherapy.The Tamilnadu Dr M G R Medical University |
| Address |
Room number - 019 Department of Advanced PT in Neurology KMCH College of Physiotherapy, Affiliated to The Tamilnadu Dr M G R Medical University, Kalapatti Road Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9751509033 |
| Fax |
|
| Email |
brammatha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Brammatha A |
| Designation |
Professor |
| Affiliation |
KMCH College of Physiotherapy.The Tamilnadu Dr M G R Medical University |
| Address |
Room number - 019 Department of Advanced PT in Neurology KMCH College of Physiotherapy, Affiliated to The Tamilnadu Dr M G R Medical University, Kalapatti Road Coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9751509033 |
| Fax |
|
| Email |
brammatha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
SF No 259 & 267, Kalapatti Road
Coimbatore,Tamil Nadu,India
641048 |
| Type of Sponsor |
Other [Private Physiotherapy College ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Shankar Iyer |
Kovai Medical Center and Hospital |
110A, Outpatient Division, Department of Neurology, Avinashi Road
Coimbatore
TAMIL NADU |
9488449892
drrajesh@kmchhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITEE KMCH INSTITUTE OF ALLIED HEALTH SCIENCES |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Conventional therapy
1.Diaphragmatic breathing is a foundational exercise that helps improve lung capacity and reduce stress. To perform it, the individual should sit or lie down comfortably, placing one hand on the chest and the other on the abdomen. They then inhale deeply through the nose, allowing the abdomen to rise while keeping the chest still, and exhale slowly through pursed lips, feeling the abdomen fall.
2.Range of motion (ROM) exercises are essential for maintaining joint flexibility and preventing stiffness. Active assisted ROM involves the patient initiating movement with help from a therapist or their unaffected limb, guiding the joint gently through its full range. Active ROM exercises are performed independently by the patient, such as arm lifts or wrist circles, to maintain mobility and muscle tone.
3.Stretching exercises target specific muscle groups to enhance flexibility and reduce tightness. For elbow flexors, the arm is extended with the palm facing up, and the opposite hand gently pushes the forearm downward, holding the stretch for 15–30 seconds. Finger extensor stretches involve extending the fingers and wrist backward, then gently pulling them toward the body to loosen the wrist and fingers.
4.Strengthening exercises without task orientation focus purely on muscle development. Isometric exercises involve contracting muscles without joint movement, such as pressing the hand against a wall and holding the tension for several seconds, which builds strength safely. Isotonic exercises include movements like bicep curls or leg lifts, where muscles contract through a range of motion with consistent tension, improving endurance and tone.
5.Progressive resisted strengthening starts with low resistance and gradually increases as the patient gains strength, using weights or resistance bands to build muscle mass and functional power.
6.Balance and walking training in parallel bar for 15 minutes
All exercises Dosage 5 times/twice/day
|
| Intervention |
Experimental group will receive Task-oriented Home Exercise Program |
Precedure and Dosage
1.Supported Arm Raise: Use a sliding board or towel to slide the affected arm forward with assistance. Purpose: Initiates shoulder flexion and promotes active movement with support.
2.Wall Touch with Elbow Support: Lean forward and touch the wall using the affected hand, supported by the elbow. Purpose: Encourages forward reach and shoulder mobility with elbow stabilization.
3.Shoulder Taps: With help from a therapist or caregiver, tap the opposite shoulder using the affected arm. Purpose: Improves cross-body coordination and shoulder range.
4Reach to Touch Alarm Clock: Place the alarm clock beside the bed and reach for it from a seated position. Purpose: Simulates daily activity and enhances lateral reach.
5.Forearm Rotation on Table: Place forearm on table and rotate palm up/down with assistance. Purpose: Restores forearm supination and pronation.
6.Towel Swipe on Table: Move a towel in a semicircular motion on the table using the affected arm. Purpose: Promotes shoulder and elbow movement in a controlled arc.
7.Knocking Door: Gently knock on a door surface repeatedly using wrist or fingers. Purpose: Encourages wrist extension and fine motor control.
8.Move Arm Between Two Targets (Attender’s Hands): Extend elbow to move arm between two targets set by the attender. Purpose: Trains midline movement and elbow extension.
9.Rotate Forearm and Tap Object: Rotate the forearm and tap a nearby object. Purpose: Improves forearm control and object interaction.
10.Pick and Drop Game: Pick small objects and place them into a bowl or container. Purpose: Develops grasp-release coordination and hand dexterity.
11.Bottle Cap Twist: Open or close a water bottle using the affected hand while the attender holds the bottle. Purpose: Simulates daily bilateral hand use and grip strength.
12.Simulated Eating Task: Scoop food with a spoon and bring it to the mouth under supervision. Purpose: Rehearses self-feeding and hand-to-mouth coordination.
13.Reach to Touch Wall/Headboard: Perform shoulder flexion by raising the arm above head level to touch the wall or headboard. Purpose: Strengthens shoulder flexors and mimics overhead reach.
14.Glass Reach and Slide: Reach for an empty cup and slide it toward the edge of the table. Purpose: Enhances reach and controlled hand movement.
15.Push-Pull Task: Push an object or door forward and then pull it back. Purpose: Builds strength and coordination in pushing/pulling motions.
Dosage:
Perform 5 repetitions twice daily.
Progression
Individual could increase time and repetition without compromising the quality of movement
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Early Subacute Middle Cerebral Artery Stroke individuals
2.Both Ischemic and Hemorrhagic Stroke
3. Both Dominant and Non – dominant hand affected.
4.Individuals with minimal voluntary control within Motricity index of 14,19 or 25 in affected side.
5.Able to sit without support for thirty sec
6. Individuals who require manual contact of no more than one person during ambulation on level surface to prevent falling or Manual contact consists of continuous or intermittent light touch to assist balance or coordination according to Functional Ambulation Category score more than 2 .
|
|
| ExclusionCriteria |
| Details |
1. Severe cognitive impairment
2. Severe joint pain caused by various factors affecting functional activities.
3. Other neurological disorders – Parkinson’s disease, Multiple Sclerosis
4. Musculoskeletal disorders like Periarthritis shoulder, Rheumatoid arthritis and contractures.
5. Sivere spasticity
6. Visual or sensory impairments
7. Apraxia and unilateral spatial neglect.
8. Sensory and Global aphasia.
9. Cardiological conditions with unstable angina, symptomatic heart failure, uncontrolled hypertension
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Motor Recovery using Fugl-Meyer assessment Upper Extremity.
2. Functional arm use using Motor Activity Log 14
3.Adherence to task oriented home exercise using Stroke Specific Measure of Adherence .
|
1. Baseline
2.Post test at 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Range of Motion of Arm Movements
2.Voluntary control |
1.Baseline
2.Post test at 4th week
|
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to evaluate effectiveness and adherence to a task oriented home exercise program on upper limb motor recovery and functional arm use in real life activities of stroke individuals. Prior to participation, the purpose and details of the study will be thoroughly explained to all eligible individuals. A written informed consent form will be obtained from each individual. Baseline assessments will be conducted prior to the intervention period. Then the upper limb motor recovery will be evaluated using Fugl Meyer Upper Extremity and Functional arm use evaluated by Motor Activity Log14.The experimental group receive real life functional Task Oriented exercises in Home setup along with certain associated exercises included as part of the intervention for 4 weeks, and control group receive Conventional therapy (Standard usual clinical practice). Both groups will receive treatment for duration of 6 days per week for 4 weeks for 45min. To both groups Post-intervention, the same measures will be used to reassess functional change and adherence level by Stroke Specific Measure of Adherence to Home based Exercise at end of 4 weeks. |