| CTRI Number |
CTRI/2025/11/097127 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Power of Practice: Restoring Hand Function After Stroke |
|
Scientific Title of Study
|
Effect of Repetitive Functional Movements on Hand Dexterity and Grip Strength in Acute Stroke Patient: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YASHIKA MOTWANI |
| Designation |
Student(Intern) |
| Affiliation |
Pravara Institute Of Medical Sciences |
| Address |
Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU loni Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU loni Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
07796529454 |
| Fax |
|
| Email |
yashika.h.motwani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
YASHIKA MOTWANI |
| Designation |
Student(Intern) |
| Affiliation |
Pravara Institute Of Medical Sciences |
| Address |
Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU loni Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU loni Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
07796529454 |
| Fax |
|
| Email |
yashika.h.motwani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhur Kulkarni PT |
| Designation |
Associate Professor |
| Affiliation |
Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU |
| Address |
Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU loni Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences DU loni Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
7588009063 |
| Fax |
|
| Email |
madhurkulkarni19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital Pravara Institute Of Medical Sciences Loni, Tal. Rahata, Dist. Ahmednagar, Maharashtra, India 413736 |
|
|
Primary Sponsor
|
| Name |
Yashika Motwani (self) |
| Address |
Pravara Medical Sciences Rahata, Loni, Ahmednagar, Maharashtra 413736 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Yashika Motwani |
Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital |
Medicine Ward, In-Patient Department (IPD),
Rural Medical College and Hospital,
Pravara Institute of Medical Sciences (Deemed to be University),
Loni, Taluka Rahata,
Ahmednagar, Maharashtra – 413736, India Ahmadnagar MAHARASHTRA |
07796529454
yashika.h.motwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hand Dexterity & Functional Training Protocol for Patients with Upper limb Paresis |
The Group will be given repetitive functional training exercises along with standard Physiotherapy treatment for one week screening will be done Pre and Post one week |
| Comparator Agent |
Standard Physiotherapy Treatment |
Screening will be done Pre and Post and the participants will receive Standard Physiotherapy Treatment for a week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Acute stroke patient within 1 to 2 weeks of onset
2. Mild-to-moderate dexterity impairment
3. Box and Block Test greater than 1
4. Patients with upper limb involvement
5. Ability to follow simple instructions
6. Voluntary Control minimum grade 3
7. Participants who are willing to give informed written consent |
|
| ExclusionCriteria |
| Details |
Any other Musculoskeletal or neurological condition affecting hand dexterity
Severe cognitive deficits
Chronic stroke patient
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand Dexterity: Measured using the Box and Block Test (BBT)
Grip Strength: Assessed with a dynamometer
Functional Ability: Evaluated through Fugl-Meyer Assessment (FMA)
|
Baseline (pre-intervention) and at 1 week (post-intervention).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barthel Index |
aseline (pre-intervention) & at 1 week (post-intervention).
|
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
25/11/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Stroke frequently results in upper limb dysfunction, with up to 80% of patients experiencing reduced hand dexterity and grip strength, which limits their ability to perform daily activities. Repetitive and task-specific rehabilitation is known to stimulate neuroplasticity and promote motor recovery. This randomized controlled trial aims to evaluate the effect of repetitive functional movements on hand dexterity and grip strength in acute stroke patients.
Thirty-eight participants will be randomly allocated into two groups. The Control group will receive conventional physiotherapy including passive and active range of motion exercises, balance and coordination training, strengthening exercises, gait training with assistive devices, and gentle stretching or yoga-based mobility exercises. The Experimental group will receive the same conventional therapy along with a structured Repetitive Functional Movement Training protocol consisting of progressive phases focusing on facilitation, skill development, and functional integration. Exercises include finger individuation, grip–release, fine motor and object manipulation tasks, and functional activities such as bottle opening, zipper training, and towel wringing.
Intervention will be given six sessions per week for one week. Outcome measures will include the Box and Block Test, hand-held dynamometer,Barthel Index, and Fugl-Meyer Assessment. The study anticipates greater improvement in hand dexterity and grip strength in the experimental group compared to the control group. |