| CTRI Number |
CTRI/2022/02/040191 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/02/2022 |
| 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
|
Effect of Functional Electrical Stimulation and Motor Relearning Programme approach on Gait in Stroke individuals |
|
Scientific Title of Study
|
Effect of Functional Electrical Stimulation and Motor Relearning Programme approach on Gait Parameters in individuals with Sub-acute Stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan Dewan |
| Designation |
PG Student |
| Affiliation |
Amity Institute of Physiotherapy,Amity University sector-125, Noida, Uttar Pradesh, India |
| Address |
Amity Institute of Physiotherapy, F- Block, Amity University sector-125, Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9810833806 |
| Fax |
|
| Email |
gunjandewan2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Physiotherapy, Amity University sector-125, Noida, Uttar Pradesh, India |
| Address |
Amity Institute of Physiotherapy, F- Block, Amity University sector-125, Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Gunjan Dewan |
| Designation |
PG Student |
| Affiliation |
Amity Institute of Physiotherapy, Amity University sector-125, Noida, Uttar Pradesh, India |
| Address |
Amity Institute of Physiotherapy, F-Block, Amity University sector-125, Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9810833806 |
| Fax |
|
| Email |
gunjandewan2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vimhans Nayati Super
Specialty Hospital |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
- |
| Type of Sponsor |
Other [NA] |
|
|
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 Prateek Gaur PT |
Vimhans Nayati Super Specialty Hospital |
Neurology Rehabilitation Department, Vimhans Nayati Super Speciality Hospital, 1, Institutional Area, Nehru Nagar, Lajpat Nagar, New Delhi
South
DELHI |
9891304886
prateek.physiotherapist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amity Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FES and MRP |
In MRP first the Analysis of function and then Practicing missing components then the whole task is practiced and then training is transferred and later on FES stimulation will be given. MRP will be given for 30 minutes in each session of five days in one week for three weeks.
Dual channel FES will be used on Tibialis anterior & Gluteus medius. FES will be delivered at frequency of 40Hz with pulse width of 200 ðœ‡s. The current amplitude will be adjusted to each patient’s maximum tolerable intensity. The gait will be set at 5s on and 5s off. Stimulation will be given for 30 minutes per session, one session each day, and five days in one week for three weeks.
So total treatment duration will be 60 minutes including 30 minutes of MRP and 30 minutes of FES which is given for 5 days a week for 3 weeks.
|
| Comparator Agent |
MRP |
The tasks will be done to stimulate hip extension in supine by pushing the heel on the chair and in standing position by practicing hip extension, to train knee control in sitting position by moving the leg in various degrees of knee flexion & extension and in standing position by stepping the leg forward and backward, to train lateral horizontal pelvic shift in standing position by laterally shifting pelvis in stance phase; and to train knee flexion in prone lying and standing position by flexing the knee to various degrees, to stimulate knee extension and dorsiflexion at heel strike in standing position by keeping the knee in extension and shifting the weight forward to stimulate the stepping forward with heel down first in swing phase.
So, treatment duration will be 30 minutes of MRP per session for 5 days in a week for 3 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with 3 weeks to six months after stroke onset
Age 45-60 years
Individuals with MCA stroke
Individuals with and without usage of assistive device
Individuals who are able to walk 10-meter distance
Individuals with foot drop
Male and female individuals will be included
Stable medical conditions
|
|
| ExclusionCriteria |
| Details |
Individuals with severe cardiopulmonary and respiratory conditions
Severe sensory disturbance
Individuals with ataxia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gait speed and Cadence |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Ambulation Classification (FAC) and Tinetti Gait Scale |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim- Aim of the study is to measure effect of Functional Electrical Stimulation along with Motor Relearning Programme approach on Gait speed and Cadence in sufferers with Sub-acute Stroke. Design- Randomized Control Trial Participants- In this study, 30 sub-acute stroke individuals will be taken out of which 15 individuals will be assigned randomly to Experimental Group and 15 individuals to Conventional Group. Intervention- In Experimental Group both FES and MRP will be given and in Conventional Group only MRP will be given. Outcome measures- Primary outcome of this study will be gait speed and cadence. Secondary outcome will be Ambulation and Gait. |