| CTRI Number |
CTRI/2025/05/087877 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study investigates how adjusting the environment can support hand recovery after Stroke |
|
Scientific Title of Study
|
Effect of environmental modifications for improving hand function in subacute stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitwan Agrawal |
| Designation |
PG Student |
| Affiliation |
MGM School Of Physiotherapy |
| Address |
Department of Neuro Physiotherapy. 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7447235124 |
| Fax |
|
| Email |
agrawalchitwan16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sant |
| Designation |
Associate Professor |
| Affiliation |
MGM School Of Physiotherapy |
| Address |
Department of Neuro Physiotherapy. 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8087671018 |
| Fax |
|
| Email |
namratasant08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitwan Agrawal |
| Designation |
PG Student |
| Affiliation |
MGM School Of Physiotherapy |
| Address |
Department of Neuro Physiotherapy. 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
MAHARASHTRA
431001
India |
| Phone |
7447235124 |
| Fax |
|
| Email |
agrawalchitwan16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of neuro physiotherapy no. 5 MGM School of Physiotherapy, N6 Cidco Aurangabad
431001, maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
Department of neuro physiotherapy no. 5 MGM School of Physiotherapy, N6 CIDCO, Aurangabad 431001, Maharashtra, India |
| Type of Sponsor |
Private medical 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 Chitwan Agrawal |
MGM School of Physiotherapy |
MGM School of
physiotherapy, Neuro OPD room number 5, C
building N6 Cidco
Chhatrapati
Sambhajinagar
Maharashtra 431001,
India
Aurangabad
Maharashtra
Aurangabad
MAHARASHTRA |
7447235124
agrawalchitwan16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics committee for Research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Task oriented training and conventional physiotherapy |
Task-oriented training will include large-sized (3 cm) caps, rough textures made of net/dishwasher mesh, and large (1 L) bottles.
Conventional physiotherapy treatment consists of stretching of tight muscles 10 repetitions×1 set of strengthening, 10 repetitions×1 set of breathing exercises, 10 repetitions×1 set of range of motion exercises, 10 repetitions×1 set of bridging, 10 repetitions×1 set of quadruped position, and 10 repetitions×1 set of reach-outs. |
| Intervention |
Task oriented training with environmental modifications and conventional physiotherapy protocol |
Task-oriented training includes making the patients do functional tasks with small-sized caps (2cm diameter), textures for differents (smooth), and small (500 mL) bottles.
Conventional physiotherapy treatment consists of stretching of tight muscles 10 repetitions×1 set of strengthening, 10 repetitions×1 set of breathing exercises, 10 repetitions×1 set of range of motion exercises, 10 repetitions×1 set of bridging, 10 repetitions×1 set of quadruped position, and 10 repetitions×1 set of reach-outs. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with subacute Stroke
2. Gender both Female and male
3. MOCA score more than 26
4. Patient is vitally stable
5. Age group to 65 years
6. Patient is willing to participate
7. Brunnstrom Upper extremity stage of recovery
|
|
| ExclusionCriteria |
| Details |
1. Recent fracture or Deformity
2. Visual impairment
3. Auditory impairment
4. Sensory Aphasia
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Box and block test |
Pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wolf motor function test |
Pre-intervention & post intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of the study is to evaluate the effect of environmental modifications for improving hand function in subacute stroke patients. The objectives of the study are to find out pre- and post-treatment scores of task-oriented training on the box and block test and the Wolf Motor Function Test in Groups A and B. Also to compare the post-treatment scores of the Box and Block Test and Wolf Motor Function Test in group A and group B.
|