| CTRI Number |
CTRI/2024/02/063373 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving hand functions using videos in stroke patients. |
|
Scientific Title of Study
|
Combination of motor relearning program and action observation therapy for improving function of upper extremity after a 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 |
Divya |
| Designation |
Student(Masters of physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre Institute of Rehabilitation |
| Address |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Vasant Kunj Rd, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi 110070
South
DELHI
110070
India |
| Phone |
8447667998 |
| Fax |
|
| Email |
divyarani612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Stuti Sehgal |
| Designation |
Associate professor |
| Affiliation |
Indian Spinal Injuries Centre Institute of Rehabilitation |
| Address |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Vasant Kunj Rd, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi 110070
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Vasant Kunj Rd, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi 110070
South
DELHI
110070
India |
| Phone |
9891847488 |
| Fax |
|
| Email |
sehgalstutiss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya |
| Designation |
Student(Masters of physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre Institute of Rehabilitation |
| Address |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Vasant Kunj Rd, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi 110070
South
DELHI
110070
India |
| Phone |
8447667998 |
| Fax |
|
| Email |
divyarani612@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support- Indian spinal injuries center, institute of rehabilitation sciences |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [none] |
|
|
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 |
| Stuti sehgal |
Indian Spinal Injuries Centre Institute of Rehabilitation |
Indian Spinal Injuries Centre Institute of Rehabilitation, sector C, Vasant Kunj, IAA Colony, New Delhi 110070
South
DELHI |
9891847488
sehgalstutiss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Centre- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Action Observation therapy in combination with Motor relearning programme for 4 weeks. |
functional training of upper extremity by motor relearning programme with the help of videos of same task for 4 weeks. |
| Comparator Agent |
Motor relearning programme |
training of upper extremity functional training by analyzing and training of correct movement pattern |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
first onset of stroke with six months of recovery period
hemiparetic stroke with ischemic or hemorrhagic stroke
motor recovery of hand- brunnstrom stages four and five
MMSE more than 24 |
|
| ExclusionCriteria |
| Details |
Comorbidities that influenced upper extremity usage or cause severe pain
Subjects have severe neglect of the affected part
Subjects having severe spasticity of upper extremity (grade 3 and 4 in modified ashworth scale)
Subjects having apraxia, hemianopia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FUGL – MEYER ASSESSMENT SCALE -UPPER EXTREMITY |
Measure at baseline(Pre-Test)
Measure at 4 weeks(Post-Test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wolf motor Functional test |
Measure at baseline(Pre-Test)
Measure at 4 weeks(Post-Test) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
11/03/2024 |
| 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 is one of the most frequently occurring disabling diseases in the world. Upper limb paralysis is a common and undesirable consequence of all types of stroke that leads to functional limitations such as dressing, bathing, self-care, writing etc. Even though there are many rehabilitation methods to improve upper limb function, it is necessary to investigate an effective method to improve upper extremity function for stroke survivors. Thus, this study is to find out the changes that occur with the combination of motor relearning programme and Action Observation Therapy on improving the upper limb functions. Motor Relearning programme focuses on task specific learning through effective use of feedback and practice. The studies have shown that it is effective in enhancing motor function recovery of post stroke paretic limb. Action observation approach has demonstrated an important role in stroke motor recovery by activating the neural system of the brain. AO forms the basis of learning through imitation and consists of one person observing the performance of a motor task, either on a video or a real demonstration. This research will help us to evaluate the combined effect of the Motor Relearning Program and Action observation therapy for improving function of the upper extremity in stroke survivors and to see motor recovery and improvement in functionality of paretic limb and better independence in daily life activities. Subjects will be divided into 2 groups : One group (Experimental 1) will made to perform combination of MRP and AOT for 5 times a week for 4 weeks. The second group (Experimental 2) will receive MRP along with general exercises. The outcome measurements which will be used to assess: FUGL – MEYER ASSESSMENT SCALE WOLF MOTOR FUNCTION TEST
|