| CTRI Number |
CTRI/2025/12/098392 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [occupational therapy ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Movement re-training Program with regular Occupational Therapy: A Way to Improve Arm Function in Patients with Brain Tumours having arm, hand weakness. |
|
Scientific Title of Study
|
A Prospective Interventional Study on the Effectiveness of the Motor Relearning Program Combined with Conventional Occupational Therapy in Improving Hemiparetic Upper Limb Function in Patients with Brain Tumours |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjusha Vagal |
| Designation |
Professor and Office In-Charge, Occupational therapy department |
| Affiliation |
Tata Memorial Hospital and Research Centre |
| Address |
Occupational Therapy department 94 Main Building Ground floor,Tata Memorial Hospiatal Parel mumbai. Occupational Therapy department 94 Main Building Ground floor,Tata Memorial Hospiatal Parel mumbai. Mumbai (Suburban) MAHARASHTRA 400012 India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tina Parkar |
| Designation |
PG Student |
| Affiliation |
Tata Memorial Hospital and Research Centre |
| Address |
Occupational Therapy department 94 Main Building Ground floor,Tata Memorial Hospiatal Parel mumbai. Occupational Therapy department 94 Main Building Ground floor,Tata Memorial Hospiatal Parel mumbai. Mumbai MAHARASHTRA 400012 India |
| Phone |
9773792224 |
| Fax |
|
| Email |
tinaparkar8@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tina Parkar |
| Designation |
PG Student |
| Affiliation |
Tata Memorial Hospital and Research Centre |
| Address |
Occupational Therapy department 94 Main Building Ground floor,Tata Memorial Hospiatal Parel mumbai. Occupational Therapy department 94 Main Building Ground floor,Tata Memorial Hospiatal Parel mumbai. Mumbai MAHARASHTRA 400012 India |
| Phone |
9773792224 |
| Fax |
|
| Email |
tinaparkar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| TATA MEMORIAL HOSPITAL ,PAREL MUMBAI |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjusha Vagal |
Tata Memorial Hospital |
Room number 94, Main building, Occupational Therapy Department, Tata Memorial Hospital, Parel 12, Mumbai, Maharashtra. Dr. E Borges Road, Parel, Mumbai-400012 Mumbai MAHARASHTRA |
9867552266
vagalmanjusha@yahoo.com |
| DR TINA PARKAR |
Tata Memorial Hospital |
Room number 94, Main building, Occupational Therapy Department, Tata Memorial Hospital, Parel 12, Mumbai, Maharashtra. Dr. E Borges Road, Parel, Mumbai-400012 Mumbai MAHARASHTRA |
09773792224
tinaparkar8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
motor relearning program |
a scientifically-grounded, task-oriented intervention based on principles of movement science, neuroscience, and motor learning |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Brain Tumors patients presenting with Hemiparesis.
2)Hemiparetic upper limb with Brunnstrom stage 2 and above.
3)Patients treated with Surgery, with or without Radiation therapy and Chemotherapy .
4)Age range - 18 to 75.
5)Both male and female .
6)Patient able to follow verbal commands.
7)Patient able to understand Hindi , Marathi or English language .
8)Patients having smart phone |
|
| ExclusionCriteria |
| Details |
Patients with Apraxia .
• Premorbid Neuromuscular disorder ( Traumatic Brain Injury , Parkinson's etc ).
• Patients with involuntary movements |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The Jebsen-Taylor Hand Function Test to evaluate changes in fine and gross motor skills of
the hand.
2)The Canadian Occupational Performance Measure to capture changes in functional
participation .
3)The Fugl-Meyer Assessment to measure improvements in motor and sensory recovery of
the upper limb. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="57" Sample Size from India="57"
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)
|
05/11/2026 |
| 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="8" Days="15" |
|
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
|
Many people who will undergo treatment for brain tumours—such as surgery, radiation, or chemotherapy—may experience weakness or reduced control in one side of body including upper limb and hand known as hemiparesis. Hemiparesis cause difficulties in performing daily tasks like dressing, eating, or writing. We propose to carry out a prospective interventional study aiming at finding out whether a special therapy approach called the ‘Motor Relearning Program (MRP)’—when combined with regular ‘Occupational therapy’ over the period of four week for patients, male or female, of age group 18 to 75 treated for or undergoing treatment for brain tumor presenting with hemiparesis, can help improve arm movement and function. A total of 57 participants will be included in the study. Each participant will receive two therapy sessions per week for one month, delivered by trained Occupational therapists.The therapy will focus on helping them re-learn how to use their affected arm through guided practice of everyday tasks, feedback, and goal-setting. The research team will assess the participants’ arm function and ability to perform daily activities before and after the therapy program using standard measurement tools like Jebson Taylor Hand Function test , COPM and Fugl Myer assessment . By comparing the pre and post results, they will determine whether the combination of therapies leads to improved movement and greater independence in brain tumour patient presenting with hemiparetic upper limb .This study will aim to provide better rehabilitation strategies that could help people with brain tumours regain their independence and improve their quality of life. |