| CTRI Number |
CTRI/2019/06/019905 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
29/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Brunnstroms hand rehabilitation on stroke patients |
|
Scientific Title of Study
|
Combined effect of Brunnstrom’s hand rehabilitation and functional electrical stimulation on hand function in patients with stroke: two group pretest post-test design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahemun Akter |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar (Deemed to be University)
Mullana Ambala Haryana 133207 India
Ambala
HARYANA
133207
India |
| Phone |
7082163614 |
| Fax |
|
| Email |
rahemun66@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Nidhi Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar (Deemed to be University)
Mullana Ambala Haryana 133207 India
Ambala
HARYANA
133207
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Adarsh Kumar Srivastav |
| Designation |
University Research Fellow (URF) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar (Deemed to be University)
Mullana Ambala Haryana 133207 India
Ambala
HARYANA
133207
India |
| Phone |
8618889003 |
| Fax |
|
| Email |
adarsh.srivastav@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Deemed to be University Mullana Ambala Haryana 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Deemed to be University |
| Address |
Mullana Ambala Haryana 133207 India |
| Type of Sponsor |
Private medical college |
|
|
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 Subhasish Chatterjee |
Maharishi Markandeshwar Hospital |
Department of Neuro Physiotherapy
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Mullana Ambala Haryana 133207
Ambala
HARYANA |
8059930240
subhasishphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Only conventional therapy for 4 weeks 5 days per week |
| Intervention |
Experimental group |
Brunnstrom hand training and functional electrical stimulation along with conventional therapy for 4 weeks 5 days per week
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Brunnstrom stage 1-3
Chronic Stroke
Age group 40-70 years
Both male and female
MMSE score > 24
|
|
| ExclusionCriteria |
| Details |
Shoulder hand syndrome
Demyelinating and degenerative diseases of the brain
Intra cranial tumors
Recent fracture
Acute cardio respiratory diseases
Hearing deficit
Visual deficit
Uncooperative patient
Recent neuro-surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl Meyer Assessment Scale |
2 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Handheld dynamometer
Jebsen-taylor hand function test
Modified Ashworth Scale |
2 times |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2019 |
| Date of Study Completion (India) |
30/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
After completion of the study we will sent the manuscript to a peer reviewed journal for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Participants will be provided with written consent form for the voluntary participation. The purpose of the study will be explained to the willing patient following which the informed consent will be collected. Patient will be screened for the inclusion and exclusion criteria and the demographic data will be collected from the eligible patient. Participants will be randomly divided into control and experimental group. Hand function will be assessed by Fugl Meyer Assessment scale; grip strength will be measured by handheld dynamometer, spasticity will be measured by Modified Ashworth Scale, hand function by Jebsen-taylor hand function test. The experimental group will be received Brunnstrom hand training and functional electrical stimulation along with conventional therapy and control group will be received only conventional therapy. The treatment will be continued for 4 weeks; 5 days per week. Data will be collected pre intervention and 4 weeks after intervention.
|