| CTRI Number |
CTRI/2025/07/091676 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| 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
|
Effectiveness of Functional Electrical Stimulation (FES) on hand pain and function in People with Stroke |
|
Scientific Title of Study
|
Effectiveness of Functional Electrical Stimulation on hand pain and function in People 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 |
Ehsanur Rahman |
| Designation |
Ph.D. Student |
| Affiliation |
Assistant Professor, Department of Physiotherapy and Rehabilitation |
| Address |
Department of Biomedical Engineering, Jashore University of Science and Technology (JUST), Jashore
Jashore University of Science and Technology (JUST)
7408
Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hassan M AlEmran |
| Designation |
Associate Professor |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Biomedical Engineering, Jashore University of Science and Technology (JUST), Jashore
7408
Other |
| Phone |
8801627551090 |
| Fax |
|
| Email |
al-emran@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hassan M AlEmran |
| Designation |
Associate Professor |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Biomedical Engineering, Jashore University of Science and Technology (JUST), Jashore
7408
Other |
| Phone |
8801627551090 |
| Fax |
|
| Email |
al-emran@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| University Grants Commission through Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
UGC Building, Plot: E-18/A, Agargaon Administrative Area, Sher-E-Bangla Nogor, Dhaka-1207, Bangladesh. |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Md Waliul Islam Lecturer of Physiotherapy Bangladesh Health Professions Institute BHPI |
Centre for the Rehabilitation of the Paralysed (CRP) |
CRP, Savar, Dhaka-1343, Bangladesh.
|
8801717928486
olee32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh |
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 |
| Intervention |
Functional Electrical Stimulation (FES) with Usual Treatment |
The intervention group will receive a one-hour treatment that includes functional electrical stimulation (FES) for 30 minutes and usual physiotherapy treatment (UPT) for another 30 minutes. Training will be provided to the physiotherapists on FES application before starting the intervention. The XFT-2003EA H2 Hand Rehab System device will be used to deliver electrical stimulations which can be driven up to 60 mA amplitude 21 to the target wrist extensor muscles according to individual’s tolerance. Participants will be given a standard warning for the use of electrical stimulation, which includes watching for signs of skin burn. The electrodes of FES will be placed on the extensor carpi radialis longus and brevis and the extensor carpi ulnaris 22. FES will be administered for 30 minutes per point, 3 days a week, and for a total of 8 weeks while performing movement exercise and gripping practice. Each session will last 60 minutes and each participant will receive a total of twenty sessions of treatment. |
| Comparator Agent |
Usual Treatment |
Control group participants will receive usual physiotherapy care. To precisely replicate a range of articular movements and muscle and soft tissue elongation, the primary goal of this treatment will be to provide passive range-of-motion exercises in those segments where no active movement will be recorded. Sensory techniques, such as brushing and icing, will be used to increase or decrease spasticity of the affected wrist joint while doing different wrist movements. These exercises will be performed manually on the affected hemiparetic joints and muscles of the upper limb. In areas where residual movement is detected, participants will be encouraged to actively exercise with the help of therapists. Exercises will be tailored to each participants specific needs in terms of type, intensity, and duration. The duration of the usual physiotherapy for the upper limb will be 60 minutes consisting of 30 minutes of spasticity management & relaxation, 30 minutes for movement exercise and gripping practice. Every participant will receive a total of twenty sessions for eight weeks of treatment. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
To be included for participation in this study process, individuals must (1) possess a verified diagnosis of unilateral ischemic stroke by either CT or magnetic resonance imaging, (2) exhibit stable vital signs and normal levels of consciousness, (3) demonstrate a Brunnstrom recovery stage 1 to 4 for the functionality of the affected upper limb 20, (4) 2-4 months after stroke onset, (5) must give consent to attend in the study. |
|
| ExclusionCriteria |
| Details |
Subjects will be accounted as disqualified if they (1) have a prior medical history of stroke, including both reversible and hemorrhagic strokes (2) experience severe cognitive impairment, speech or communication difficulties (3) are diagnosed with mental health disorders, (4) implanted cardiac pacemaker, (5) unable to receive treatment for the specific time frame. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand pain and function - NPRS, Modified Fugl-Meyer Assessment Upper Extremity (FMA-UE) |
Baseline, After 4 weeks and 8 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Manual dexterity and muscle tone - Modified Ashworth Scale, The Box and Blocks Test (BBT) |
Baseline, After 4 weeks and 8 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="128"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| 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
|
Stroke is one of the leading causes of
lifelong disability worldwide. Patients with strokes generally have upper
limb paralysis that disrupts daily life. Functional electrical stimulation
(FES) helps upper limb rehabilitation by stimulating affected muscles. This
study aims to examine FES’s efficacy on stroke-related pain and hand functional recovery. |