| CTRI Number |
CTRI/2023/12/060495 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Additive Effect of Modified Constraint Induced Movement Therapy Along with Electrical Stimulation on Upper Limb Function in chronic stroke patients- An Experimental Study |
|
Scientific Title of Study
|
Additive Effect of Modified Constraint Induced Movement Therapy Along with Electrical Stimulation on Upper Limb Function in chronic stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradnya Prabhakar Tele |
| Designation |
Master of Neurophysiotherapy student |
| Affiliation |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
7218404853 |
| Fax |
|
| Email |
pradnyatele1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palalvi Dangat Jadhav |
| Designation |
Professor and HOD of Neurophysiotherapy department |
| Affiliation |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
9423233617 |
| Fax |
|
| Email |
dr.pallavi.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Dangat Jadhav |
| Designation |
Professor and HOD of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
9423233617 |
| Fax |
|
| Email |
dr.pallavi.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR medical College Campus Ambajogai latur rd Vishwanathpuram latur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pradnya Tele |
Maharashtra Institute of Physiotherapy |
Mahaerashtra Institute of Physiotherapy MIMSR medical college campus Ambajogai Latur Rd Vishwanathpuram Latur
Latur
MAHARASHTRA |
7218404853
pradnyatele1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy Ethical Committee Latur |
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 |
Group A - Electrical Stimulation |
Group A - Electrical Stimulation - 30 minutes per day for 5 days per week for 3 weeks
|
| Comparator Agent |
Group B - Modified Constraint Induced Movement Therapy Along with Electrical Stimulation |
Group B - Modified Constraint Induced Movement Therapy will be given for 6 hours per day for 5 days per week for 3 weeks along with electrical stimulation for 30 minutes per day for 5 days per week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronic stroke (6 months or above, both ischemic and hemorrhagic)
Both the genders age group between 40 and 70 years
Modified Ashworth scale score between two or less than two in affected upper extremity
Grade 4 and above on Brunnstrom assessment scale
The minimum of 20 degrees of active wrist extension and 10 degrees active finger extension (
MMSE score more than 24 or more
|
|
| ExclusionCriteria |
| Details |
1 Patients having any orthopedic problem in affected upper
extremity
2 Patient having pain in affected upper extremity more than 3
on Visual Analog Scale
3 Patient having any perceptual and visual spatial disorders
4 Patients having cognitive or sensory deficit
5 Patients with other neurological disorders
6 Acute cardio-respiratory diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl Meyer upper extremity scale |
pre intervention assessment and post intervention assessment at the end of 3 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
04/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
My study is to see the Additive Effect of Modified Constraint Induced Movement Therapy Along with Electrical Stimulation on Upper Limb Function in Chronic Stroke Patients - An Experimental study.
36 participants fulfilling the inclusion and exclusion criteria will be included after explaining procedure and taking written consent from them and assigned randomly into 2 groups. As it is convenient to collect participants in hospital, participants will be distributed randomly will be indexed as per their visit in OPD. Odd number participants will be added in group A and even number participants will be added in group B. GROUP A- Electrical stimulation (18 participants) GROUP B- Modified Constraint Induced Movement Therapy (CIMT) with Electrical stimulation (18 participants). • The participants will be assessed with fugl Mayer grading system before and after the study. |