CTRI Number |
CTRI/2022/03/041409 [Registered on: 28/03/2022] Trial Registered Prospectively |
Last Modified On: |
29/03/2022 |
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
|
Effect of Electrical Stimulation for Stroke Patients. |
Scientific Title of Study
|
Effect of Electrical Stimulation (ES) Combined with Conventional Therapy for patients with stroke.
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mohammad Mohinul Islam |
Designation |
Physiotherapist |
Affiliation |
Bangladesh Shishu( children) Hospital, Dhaka, Bangladesh |
Address |
Bangladesh Shishu(Children) Hospital, Dhaka, Bangladesh
1207 Other |
Phone |
|
Fax |
|
Email |
mohinphysio@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr Sharmin Sultana |
Designation |
Professor |
Affiliation |
Jahangirnagar University. |
Address |
Jahangirnagar University, Department of Physics, Dhaka, Bangladesh
1342 Other |
Phone |
|
Fax |
|
Email |
ssultana@juniv.edu |
|
Details of Contact Person Public Query
|
Name |
Nadia Afrin Urme |
Designation |
Physiotherapist |
Affiliation |
Centre for the Rehabilitation of the Paralysed ( CRP), Savar, Dhaka |
Address |
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka, Bangladesh
1343 Other |
Phone |
01924013007 |
Fax |
|
Email |
afrinnadia4127@yahoo.com |
|
Source of Monetary or Material Support
|
Self funded (Mohammad Mohinul Islam, Bangladesh Shishu Hospital, Dhaka, Bangladesh) |
|
Primary Sponsor
|
Name |
Mohammad Mohinul Islam |
Address |
Bangladesh Shishu (Children) Hospital, Dhaka, Bangladesh |
Type of Sponsor |
Other [Self funded] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
Bangladesh |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
K M Amran Hossain |
Centre for the Rehabilitation of the Paralysed |
Outdoor patient of Neurology Unit, Physiotherapy Department, CRP-Savar, Dhaka-1343
|
01735661492
amranphysio@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute of Physiotherapy, Rehabilitation and Research (IPRR) |
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 |
Comparator Agent |
Conventional Treatment |
Contemporary Practice
Protocol for Stroke patients in Neurology unit, CRP, Savar:
Positioning.
Stabilization of the pelvic girdle, knees and shoulder girdle.
Sensory stimulation of U/L and L/L, Proprioceptive exercise of U/L and L/L,
Transitional movement practice ,Body schema practice,
Scapular setting exercise,
Proximal stability exercise,
Selective movement practice of U/L and L/L
Midline orientation exercise,
Bobath trunk mobilization, pelvic girdle mobilization
and shoulder girdle mobilisation, Bobath hand mobilisation and foot mobilisation,
Selective movement practice of U/L and L/L,
Functional activity training,
Core strengthening exercise,
Static sitting/ standing balance practice,
Dynamic sitting/ standing balance practice,
Stepping practice,
SPG/CPG practice,
Gait reeducation,
Stairs up and stairs down practice ,
Gym activity,
Others.
Total treatment session 45 minutes
|
Intervention |
FES with conventional therapy group |
Target area:
Elbow flexor, elbow extensors
Wrist flexor, wrist extensor
Knee flexor, Knee extensor
Ankle dorsiflexor, ankle plantar flexor
Equipment setup:
A FES device with 2 channels and 4 surface electrodes producing low-frequency currents will be used. Stimulation parameters will be set as follows:
Frequency -30HZ
Pulse width- 300mS
On: off- 10:10
Ramp up and down time- 2 seconds
Intensity- as tolerable by patients
Repetition of movement- 20 repetition for each muscle group
Total duration will be approximately 30-35 minutes including rest time of patients. Patients can take rest for 3-5 sec after every 20 repetitions. Treatment will be provided 3times a week for 6 weeks.
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Hemiplegic for longer than 6months.Spasticity present at Elbow (flexor, extensor), wrist (flexor, extensor) and knee (flexor, extensor) , ankle (dorsiflexor, plantar flexor) of hemiplegic side. According to Modified Ashworth Grading Scale score of spasticity 1+, 2, or 3.
Want to participate voluntarily.
|
|
ExclusionCriteria |
Details |
Have sensory deficit in the target area.
Contracture that could restriction in movement
Taking medication to reduce spasticity.
Unstable comorbid conditions.
Cognitive impairment.
Unwilling to participate.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Primary outcome- Spasticity.
Spasticity will measure by-
Modified Ashworth Scale and
Modified Tardieu Scale
|
6weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary outcome-Physical activity and functional independence.
Physical activity and Functional independence will measure by-
Upper extremity motricity index,
Lower extremity functional scale,
Barthel Index,
10-meter walk test.
|
6weeks |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="0"
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)
Modification(s)
|
Date Missing |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
02/04/2022 |
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 Applicable |
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 objective of this study is to find the effects of Functional Electrical Stimulation (FES) Combined with Conventional Therapy on Spasticity, Physical Activity and Functional Independence in Patients with Stroke. This is a RCT study and study duration is 6 month. Accessor will be blind in this study. |