| CTRI Number |
CTRI/2024/10/075845 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| 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
|
Walking and balance training using mirror and electrical stimulation intervention in participants with stroke |
|
Scientific Title of Study
|
Effectiveness of Activity-based mirror therapy combined with Neuromuscular electrical stimulation on gait and balance in individuals with 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 |
Meenal Bansal |
| Designation |
Post graduate student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences,
Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
New Delhi
DELHI
110070
India |
| Phone |
8989482325 |
| Fax |
|
| Email |
bansalme17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Garima Wadhwa |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences,
Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
New Delhi
DELHI
110070
India |
| Phone |
9650086472 |
| Fax |
|
| Email |
garimawdhw@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenal Bansal |
| Designation |
Post graduate student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences,
Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI
New Delhi
DELHI
110070
India |
| Phone |
8989482325 |
| Fax |
|
| Email |
bansalme17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi - 110070
South West
DELHI |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Sector C, Vasant Kunj, New Delhi - 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Meenal Bansal |
Indian Spinal Injuries Centre |
Sector C, Vasant Kunj,
New Delhi - 110070
South West
DELHI
New Delhi
DELHI |
8989482325
bansalme17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Activity-based mirror therapy alone |
Individuals in the experimental group 2 will receive activity-based mirror therapy alone of lower limb for 30 minutes, 5 times a week for 4 weeks. |
| Intervention |
Activity-based mirror therapy combined with Neuromuscular electrical stimulation |
Individuals in the experimental group 1 will receive neuromuscular electrical stimulation while performing activity-based mirror therapy for 30 minutes, 5 times a week for 4 weeks. Stimulation electrodes will be placed on subjects paretic lower limb muscles- ankle dorsi-flexors and plantar-flexors, knee flexors and extensors, hip abductors. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with first episode of unilateral stroke with hemiparesis.
2.More than 3 months after stroke onset.
3.Functional ambulation classification (FAC) level 2 and above.
4.Those capable of independent walking with or without assistance for 10 meters or more.
5.Brunnstorm more than or equal to 4 (motor recovery stage).
6.Score of 26 or higher on MOCA.
|
|
| ExclusionCriteria |
| Details |
1.Any pre-existing neurological condition other than stroke.
2.Fixed contracture or any lower limb deformity.
3.Any spinal deformity.
4.Surface sensory loss of affected lower limb.
5.Any cognitive and perceptual deficit that would make participation in the study difficult.
6.Subjects having brainstem, cerebellar and any other subcortical lesions.
7.Any medical condition that would affect the patients ability to comply with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TechnoBody Walkerview
10-meter walk test(10MWT)
|
0 weeks(Baseline, Pre-test) and 4 weeks(Post-test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mini-BESTest |
0 weeks(Baseline, Pre-test) and 4 weeks(Post-test) |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/10/2024 |
| 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="7"
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 a cardiovascular accident in which there is the sudden loss of neurological function caused by interruption of the blood flow characterized by impairments of sensory, motor, cognitive, perceptual and language functions that leads to functional dependence, abnormal gait and balance and deficits in ability to transfer weight. Activity-based mirror therapy and Neuromuscular Electrical Stimulation (NMES) are two promising interventions that have shown to improve gait and balance in individuals with various neurological disorders, but their combined effectiveness has not been explored yet. Hence this research aims to find their effectiveness on gait and balance in individuals with stroke. Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. (Experimental group 1) will receive Activity-based mirror therapy combined with Neuromuscular electrical stimulation and conventional physiotherapy 5 times a week for 4 weeks. (Experimental group 2) will receive Activity-based mirror therapy alone along with conventional physiotherapy for the same time duration. The outcome measurements will be done by TechnoBody Walker View, 10-Meter Walk Test and Mini-BESTest. Variations in the pre and post outcome measurements will help us find out the effectiveness of Activity-based mirror therapy combined with NMES on gait and balance in stroke. |