| CTRI Number |
CTRI/2024/02/062279 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| 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
|
investigation of electrical stimulation induced changes in nerves and muscles in individuals with post stroke paralysis |
|
Scientific Title of Study
|
Investigation of functional electrical stimulation on electrophysiological changes in upper extremity from functional perspective among individuals with Hemiparesis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSHAN LAL MEENA |
| Designation |
Lecturer (Physiotherapy) |
| Affiliation |
Department of Physiotherapy |
| Address |
PDUNIPPD 4-V.D, Marg , New Delhi 110002
PANDIT DEENDAYAL UPADHYAYA NATIONAL INSTITUTE FOR THE PERSONS WITH PHYSICAL DISABILITIES, NEW DELHI 110002
New Delhi
DELHI
110002
India |
| Phone |
9811368079 |
| Fax |
|
| Email |
roshan7leo@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Room No. 5 Department of Physiotherapy, Punjabi University, Patiala
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147002
India |
| Phone |
9811368079 |
| Fax |
|
| Email |
sandyraina24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ROSHAN LAL MEENA |
| Designation |
Lecturer (Physiotherapy) |
| Affiliation |
Department of Physiotherapy |
| Address |
Room No. 21
PDUNIPPD 4-V.D, Marg , New Delhi 110002
Room No. 21
PANDIT DEENDAYAL UPADHYAYA NATIONAL INSTITUTE FOR THE PERSONS WITH PHYSICAL DISABILITIES, NEW DELHI 110002
New Delhi
DELHI
110002
India |
| Phone |
9811368079 |
| Fax |
|
| Email |
roshan7leo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Pandit Deendayal Upadhayaya National Institute for the Persons with Physical Disabilities, 4- Visnu Digamber Marg, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
PDUNIPPD |
| Address |
4 VISHNU DIGMBER MARG NEW DELHI |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ROSHAN LAL MEENA |
Pandit Deendayal Upadhyaya National Institute for the Persons with Physical Disabilities |
Room No. 21,
Department of Physiotherapy,
4 VSHNU DIGMBER MARG NEW DELHI 110002
New Delhi
DELHI |
9811368079
roshan7leo@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pandit Deendayal Upadhayaya National Institute for the Persons with Physical Disabilities |
Approved |
| Institutional Ethical Committee, Punjabi University, Patiala, Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FUNCTIONAL ELECTRICAL STIMULATION |
Functional Electrical Stimulation will be given to the experimental group for thirty minutes per session for total five sessions per week for four weeks. |
| Intervention |
Structured Therapeutic Exercises |
Structured Therapeutic Exercises will be given to both the experimental and control group for thirty minutes per session, total five five sessions per week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Ipsilateral Hemiparesis following stroke either ischemic or hemorrhagic
Three months to one year of the stroke.
Hemiparesis having grade 1+ to 3 on Modified Ashworth Scale of Biceps Brachi, wrist flexors and finger flexors
Individuals of the both the gender age group between 40 years and 60 years
Both male and females
Individual willing to participate voluntarily in the study
|
|
| ExclusionCriteria |
| Details |
Bilateral Hemiparesis
Hemiparesis following reason or caused other than stroke such as head injury, multiple sclerosis.
Any previous history of stroke
History of Brain or spinal cord tumor, injury or surgery
Stroke patients having other co morbidities such as Alzemer,s disease, Parkinson’s disease, and dementia that preclude their participation in the study.
Participants having severre spasticity and contracture in the elbow, hand and fingers.
Individual with uncontrolled hypertension
Individual with any systemic illness
Individual with hypersensitivity or hypersensitivity disorders and
Participants not able to follow the instructions and having difficulty in comprehension. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ELECTROMYOGRAPHY AND NERVE CONDUCTION VELOCITY STUDIES |
First outcome baseline assessment will be done at first visit before starting the intervention.
Second outcome assessment will be done at the end of fourth week of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fugal-Meyer Upper Extremity functional scale and modified Ashworth scale |
four weeks |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
12/02/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No studies published related to this study till date |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the main purpose of our study is to examine the Functional Electrical Stimulation (FES) induced effects in the neuromuscular tissues (nerves and muscles); functional activities, muscle firing and spasticity in the post stroke hemiparetic individuals. The second purpose of our study is to correlate the FES induced effects in the neuromuscular tissues with the functional activities, muscle firing and spasticity in the upper extremity of post stroke hemiparetic individuals. Alternate: Functional Electrical Stimulation Produces Significant effects in Neuromuscular tissues and Functional Activities in post stroke hemiparetic individuals Null Hypothesis: There is no significant effect of Functional Electrical Stimulation in Neuromuscular tissues and Functional Activities in post stroke hemiparetic individuals |