| CTRI Number |
CTRI/2025/12/098799 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Electrical Stimulation During Functional Proprioceptive Neuromuscular Facilitation Training on Hand Function and Spasticity Among Individuals with Sub Acute Stroke |
|
Scientific Title of Study
|
Effect of Electrical Stimulation During Functional Proprioceptive Neuromuscular Facilitation Training on Hand Function and Spasticity Among Individuals with Sub Acute 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 |
Nongmaithem Pujan Devi |
| Designation |
students |
| Affiliation |
University |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA ,(UP)-201301, INDIA, Room no 101
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA,Room no 101
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8119072020 |
| Fax |
01204735613 |
| Email |
pujannong@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant professor |
| Affiliation |
Amity Institute of health Allied sciences |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
01204392768 |
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant professor |
| Affiliation |
Amity Institute of health Allied sciences |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
01204392768 |
| Email |
ajain@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA |
|
|
Primary Sponsor
|
| Name |
Nongmaithem Pujan Devi |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA ,Room no 101 |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Sakshi soni |
Firstone Rehab Foundation |
BS-153,Sector70,Noida,Uttar Pradesh 201305,India
Gautam Buddha Nagar
UTTAR PRADESH |
7073260726
Drsakshisoni6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NTCC Ethical Clearance |
Approved |
| NTCC Ethical clearance certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: I608||Other nontraumatic subarachnoid hemorrhage, (3) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
electrical muscle stimulation to improve hand function and reduced spasticity. |
The first assessment of hand function and spasticity is conducted for all participants using the Michigan Hand Outcomes Questionnaire (MHQ) and the Chedoke Arm and Hand Activity Inventory-13 (CAHAI). The Modified Modified Ashworth Scale (MMAS) is used to measure spasticity. Participants will be divided into three groups at random. At the end of 4 weeks, participants will be reassessed using the same baseline tools (MHQ, CAHAI,MMAS) to evaluate changes. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Trials include adults (18 years or older with clinically diagnosed stroke )
2.Diagnosis of a first ever stroke confirmed by head CT or MRI scanning, well general
condition with stabilized vital signs and normal 3.consciousness voluntary for this study
with a signed informed consent
4.Both male and female patients.
5.Glasgow Coma Scale (GCS) score more than 10.
6.On Modified Modified Ashworth Scale patient scoring 1+, 2, or 3 |
|
| ExclusionCriteria |
| Details |
1.severe visceral organ dysfunction (e.g., heart, lung, liver, and kidney)
2.cardiac pacemaker
3.Upper limb dysfunction due to other causes
4.Recurrent stroke. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in hand function by Michigan Hand Outcomes Questionnaire (MHQ) and
Chedoke Arm and Hand Activity Inventory-13 |
4 weeks, 5 sessions/week (total of 20 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Reduction of spasticity in upper extremity in sub acute stroke by modified modified ashworth scale |
4 weeks, 5 sessions/week (total of 20 sessions) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="0"
Months="4"
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
|
TITLE: “ Effect of Electrical Stimulation During Functional Proprioceptive Neuromuscular Facilitation Training on Hand Function and Spasticity Among Individuals with Sub-Acute Stroke”Aims: To evaluate the effect of electrical stimulation during functional Proprioceptive Neuromuscular Facilitation training help improve hand function and reduce spasticity in individuals with sub acute stroke
Objective: 1.To find out the effect of electrical stimulation given during functional Propioceptive Neuromuscular Facilitation on hand function. 2.To find out the effect of electrical stimulation given during functional Propioceptive Neuromuscular Facilitation on spasticity. 3.To compare the outcomes between pre-and during-EMS application to determine the more effective timing in stroke patients. Need of the study: 1. The need of the study is that current literature has limited evidences regarding the combine effect of electrical stimulation during functional propioceptive neuromuscular facilitation to improve hand function and spasticity. 2.Studies have explored Electrical Stimulation and PNF independently but limited evidence exists on their combined application .specially targeting the hand function and reducing spasticity might give more efficient in upper limb rehabilitation.
Methodology Study Design: - Randomized Controlled Trials (RCT) Study Population & Sample: 1.-Individuals diagnosed with sub-acute stroke. (1-6 months post stroke) Selection Criteria: Inclusion criteria : Trials include adults (18 years or older with clinically diagnosed stroke 1. Diagnosis of a first ever stroke confirmed by head CT or MRI scanning, well general condition with stabilized vital signs and normal consciousness 2.voluntary for this study with a signed informed consent 3.Both male and female patients. Glasgow Coma Scale (GCS) score more than 10 4. On Modified Modified Ashworth Scale patient scoring 1+, 2, or 3 Exclusion Criteria: 1. severe visceral organ dysfunction (e.g., heart, lung, liver, and kidney) . 2. cardiac pacemaker 3. Upper limb dysfunction due to other causes . 4. Recurrent stroke. Participants in the study will be randomly assigned to three groups: Group 1 (Pre-EMS + PNF), Group 2 (During-EMS + PNF), and Group 3 (PNF only). The independent variables include proprioceptive neuromuscular facilitation (PNF) and electrical stimulation (EMS), while the dependent variables are hand function and spasticity. Before beginning the intervention, each participant’s hand function and spasticity will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ), the Chedoke Arm and Hand Activity Inventory-13 (CAHAI), and the Modified Modified Ashworth Scale (MMAS). In Group 1, electrical stimulation will be applied to the triceps and wrist extensor muscles at a frequency of 50–100 Hz for 20 minutes, followed by 30 minutes of PNF exercises. Group 2 will receive electrical stimulation simultaneously with PNF exercises, while Group 3 will perform only PNF training without electrical stimulation. The intervention will continue for four weeks, with five sessions per week, making a total of 20 sessions. After completing the intervention period, all participants will be reassessed using the same evaluation tools to measure changes in hand function and spasticity. The collected data will be analyzed using ANOVA to compare results within and between groups, and assessments will be conducted by blinded evaluators to ensure unbiased outcomes. |