| CTRI Number |
CTRI/2025/06/088472 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two different protocols on upper limb function in patient with stroke |
|
Scientific Title of Study
|
Comparison of Intermittent Long-Term Constraint Induced Movement Therapy Protocol Versus Standard Motor Relearning Program for Upper Extremity Function in Patients with 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 |
Amruta Dhondiram Doijad |
| Designation |
Professor |
| Affiliation |
D.Y.Patil College of Physiotherapy,Kolhapur |
| Address |
D.Y.Patil Medical College Hospital and Research Institute,Kadamwadi,Kolhapr,416003
Department- Neurosciences physiotherapy
Kolhapur
MAHARASHTRA
416008
India |
| Phone |
09890329249 |
| Fax |
|
| Email |
doijadamruta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shimpa Rakesh Sharma |
| Designation |
Professor |
| Affiliation |
D.Y.Patil Educational Society (Deemed to be University),Kolhapur |
| Address |
Professor,Department of General Medicine,D.Y.Patil Medical College,Kadamwadi,Kolhapur,Maharashtra
Nil
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9820017268 |
| Fax |
NIL |
| Email |
shimpasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amruta Dhondiram Doijad |
| Designation |
Professor |
| Affiliation |
D.Y.Patil College of Physiotherapy,Kolhapur |
| Address |
D.Y.Patil Medical College Hospital and Research Institute,Kadamwadi,Kolhapr,416003
Department- Neurosciences physiotherapy
Kolhapur
MAHARASHTRA
416008
India |
| Phone |
09890329249 |
| Fax |
|
| Email |
doijadamruta@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil Medical College Hospital and Research Institute,Kadamwadi,Kolhapr,416003
Department- Neurosciences physiotherapy
|
|
|
Primary Sponsor
|
| Name |
DYPatil college of physiotherapy |
| Address |
D Y Patil Medical College Hospital and Research Institute Kadamwadi Kolhapr 416003
Department Neurosciences physiotherapy |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DYPatil college of physiotherapy |
D.Y.Patil college of physiotherapy, kadamwadi, kolhapur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amruta Dhondiram Doijad |
D.Y.Patil Medical College Hospital and Research Institute,Kadamwadi,Kolhapur |
D Y Patil Medical College Hospital and Research Institute,Kadamwadi, Kolhapr 416003
Department Neurosciences physiotherapy
Kolhapur
MAHARASHTRA |
09890329249
doijadamruta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,D.Y.Patil Medical College,Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTERMITTENT LONG TERM CONSTRAINT INDUCED MOVEMENT THERAPY PROTOCOL |
one hour per day for 5 days per 6 weeks |
| Comparator Agent |
STANDARD MOTOR RELEARNING PROGRAM |
one hour per day for 5 days for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All Genders
2. Age group 40 to 70 years
3. First incidence of stroke
4. 6th day post Stroke
5. Hemiplegia due to thromboembolus of Middle cerebral artery involvement confirmed on CT or MRI
6. Brunnstroms voluntary control of affected extremity Grade 2
7. Mini Mental Status Examination (MMES) score more than 24
8. Motor Activity Log scores more than 2
9. Patient having at least one care giver at home
|
|
| ExclusionCriteria |
| Details |
1. Hemodynamically unstable patient
2. Patient who developed recurrent stroke during rehabilitation
3. History of traumatic and arthritic conditions interfering with upper extremity function
4. Patients with sensory Stroke
5. Patients who are unable to understand instructions and follow commands
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Motor activity Log-28
2.Nine Hole Peg Test
3.Fugl-Meyer Assessment Upper Extremity
4. Hand Dynamometer
|
Subjects will be evaluated 2 times-pretraining 1st week and post-training after 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Serum lactate level
|
Subjects will be evaluated 2 times pre-training 1st week & post-training after 6 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The patients with
stroke suffering from Middle cerebral artery infarct regain motor function in
lower limb early and become ambulated. But upper limb functions remain limited
causing difficulty in activities of daily living.
The two important
interventions to improve upper extremity function are Constraint induced
movement therapy and standard Motor relearning program.
The original form of
Constraint induced movement therapy involves intensive graded practice of
paretic upper extremity for 6 hours a day,5 days a week for 2 weeks (Edward
Taub).
Further evidence
shows about modified CIMT with less clinical hours and increased amount of time
to be spent on home-based practice. A study by Mithil Shah et al (2016) had
compared effects of CIMT with Motor relearning program where constraint was
given for 3 hours daily for 14 days.
This puts burden on family members / care
givers for application of sling and influences the degree and completion of
compliance. Therefore, there is a need to frame a revised protocol for CIMT.
|