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CTRI Number  CTRI/2025/08/092187 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Development and application of a new device to reduce involuntary arm movements during walking in patients with stroke 
Scientific Title of Study   Development and application of a novel electromyographic-driven multi-channel functional electrical stimulation for the management of homolateral limb synkinesis during post-stroke gait 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha Nayak 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, Kasturba Medical College Mangalore, Centre for Basic Sciences, Bejai, Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  7795611263  
Fax    
Email  manisha.kmcmlr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abraham M Joshua 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, Kasturba Medical College Mangalore, Centre for Basic Sciences, Bejai, Mangalore, Dakshina Kannada

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9886188221  
Fax    
Email  abraham.joshua@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Abraham M Joshua 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, Kasturba Medical College Mangalore, Centre for Basic Sciences, Bejai, Mangalore, Dakshina Kannada


KARNATAKA
575004
India 
Phone  9886188221  
Fax    
Email  abraham.joshua@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kasturba Medical College Mangalore, MAHE, Manipal 
Address  Department of Physiotherapy, Kasturba Medical College Mangalore, Centre for Basic Sciences, Bejai, Mangalore 575004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manisha Nayak  KMC Hospital Attavar  KMC Hospital Attavar, Nandigudda Road, Attavar, Mangalore 575002
Dakshina Kannada
KARNATAKA 
7795611263

manisha.kmcmlr2024@learner.manipal.edu 
Manisha Nayak  KMC Hospital Jyothi  KMC Hospital Mangalore, Dr B R Ambedkar Circle, Hampankatta, Mangalore, 575001
Dakshina Kannada
KARNATAKA 
7795611263

manisha.kmcmlr2024@learner.manipal.edu 
Manisha Nayak  KMC Physiotherapy outreach centre  KMC Physiotherapy outreach centre, Akshaya Hall, Bokkapatna, Mangalore 575003
Dakshina Kannada
KARNATAKA 
7795611263

manisha.kmcmlr2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Electromyographic driven multi-channel functional electrical stimulation device   Post-stroke patients with upper limb homolateral limb synkinesis during gait will undergo gait training using the electromyographic driven multi-channel functional electrical stimulation device along with conventional neurological rehabilitation one session per day, 6 days per week for 8 weeks. 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Diagnosed sub-acute (15 to 180 days) or chronic (more than 180 days) medically stable post stroke patients
2. Ability to ambulate 10m without assistance
3. HLS in the upper limb with a modal Associated Reaction Rating Scale score of more than or equal to 1
 
 
ExclusionCriteria 
Details  1. Presence of other neurological or neurobehavioral or orthopedic or cardiopulmonary conditions that could affect upper limb or gait
2. Presence of contracture in the affected upper limb
3. Patients who have received baclofen or botulinum toxin treatment within 3 months prior to the day of screening
4. Patients with cognitive impairments (Saint Louis University Mental Scale less than or equal to 26 in patients with a high school education, and less than or equal to 24 in patients who do not have a high school education)
5. Patients with complete sensory loss in the affected upper limb
6. Any active dermatological conditions that could prevent the placement of the device over the affected upper limbs
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Surface eletromyography, OpenCap, gyroscopes (two), Associated Reaction Rating Scale

 
0,4,8,12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Stroke Rehabilitation Assessment of Movement (STREAM), 10m walk test  0,4,8,12 weeks 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   01/08/2026 
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="2"
Months="0"
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 often leads to various movement impairments, including upper limb Associated Reactions (ARs) during walking. ARs are defined as automatic activities which fix or alter the posture of a part or parts when some other part of the body is brought into action by either voluntary effort or reflex stimulation. Homolateral limb synkinesis (HLS) is considered a type of non-purposive AR and refers to the involuntary movement of the limb on the same side of the body when the corresponding unilateral limb performs a voluntary movement. HLS can negatively impact various aspects of functioning, such as walking, dynamic balance, upper limb movement, activities of daily living, and self-esteem. Additionally, keeping the paretic arm in a fixed position for prolonged periods can contribute to muscular tightness and hinder balance reactions in both the upper and lower limbs, ultimately compromising overall stability. Uncertainty about the key underlying impairments has resulted in a variety of treatment approaches for HLS, many of which are not evidence based. Functional Electrical Stimulation (FES) has become an increasingly prevalent therapeutic technique in stroke rehabilitation, aimed at restoring physical movement in stroke patients with motor impairments. Although a previous study has explored the effects of FES in improving arm swing in stroke patients, it incorporated a small sample size of three patients and delivered the FES only to triceps muscle of the affected upper limb using a preset intensity. Hence this before-after study aims to develop a multi-channel electromyographic (EMG) driven FES and to find out its effectiveness in reducing HLS during gait in post-stroke patients.

The study hypothesizes that the EMG driven FES device will aid in the reduction of HLS during gait in post-stroke patients.

 
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