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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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