| 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
|
|
|
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
|
|
|
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
|
|
|
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. |