| CTRI Number |
CTRI/2023/03/050287 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Improving the upper extremity use in children with Neurological problems |
|
Scientific Title of Study
|
Comparison of mCIMT, Hand Arm Bimanual Intensive Training & Mirror Therapy to Improve Upper Extremity Function in Children with Hemiplegic Cerebral Palsy: A Double- Blinded Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Rahul Bisen |
| Designation |
Professor |
| Affiliation |
Smt. Kashibai Navale College of Physiotherapy |
| Address |
Smt. Kashibai Navale College of Physiotherapy 49/1, off westerly bypass, Narhe Pune
49/1, off westerly Bypass, Narhe , Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
7875606275 |
| Fax |
|
| Email |
rahulsinghbisen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna Ganvir |
| Designation |
Professor & Head of Department |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
MIDC, Off Manmad Road Opposite Government Milk Dairy, Vadgaon Gupta Rd, Ahmednagar, Maharashtra
MIDC, Off Manmad Road Opposite Government Milk Dairy, Vadgaon Gupta Rd, Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Rahul Bisen |
| Designation |
Professor |
| Affiliation |
Smt. Kashibai Navale College of Physiotherapy |
| Address |
49/1, off westerly Bypass, Narhe , Pune
49/1, off westerly Bypass, Narhe , Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
7875606275 |
| Fax |
|
| Email |
rahulsinghbisen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Kashibai Navale college Physiotherapy, Department of Neurophysiotherapy, Offwesterly Bypass, Narhe |
|
|
Primary Sponsor
|
| Name |
Smt Kashibai Navale College of Physiotherapy |
| Address |
49/1, off westerly bypass, Narhe , Pune- 411046 |
| 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 |
| Dr Rahul Bisen |
Smt Kashibai Navale College of Physiotherapy |
Physiotherapy OPD of smt Kashibai Navale college of Physiotherapy, NArhe Pune, Located on the Ground floor of the hospital building, OPD No 10
Pune
MAHARASHTRA |
7875606275
rahulsinghbisen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| DVVPFs College of Physiotherapy, Opp. Govt. |Milk Dairy, Post. MIDC, Ahmednagar-414111 |
Approved |
| Smt. Kashibai Navale College of Physiotherapy,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mCIMT(modified Constraint Induced Movement Therapy), HABIT( Hand Arm Bimanual Intensive Training),
Mirror therapy |
mCIMT-in this intervention the unaffected extremity is constrained so that the the hemiplegic hand is used for upper extremity function,
HABIT- In this intervention the participant is made to do exercises involving bimanual hand use for upper extremity function,
Mirror Therapy- in this intervention Mirror is used to reflect unaffected hand and the participant does exercises using this unaffected reflection of uninvolved extremity.
The above mentioned interventions will be given for 5 days/week for period of 4 weeks.
|
| Comparator Agent |
Standard Conventional Physiotherapy Exercises |
Standard established Physiotherapy exercises will be given to all the participants in all the three groups. These exercises will also be given for 5days/ week for a period of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with hemiplegic cerebral palsy.
2. Age group 3-12 years.
3. Children with score III or less on MACS(Manual Ability Classification System)
MACS Level I- Objects are handled easily and successfully.
MACS Level II- Handles most objects but with some reduced quality and/or speed.
MACS Level III- Handles objects with difficulty – the child will need help to prepare
And /or modify activities.
4. Ability to achieve minimum of 10 degrees of active wrist extension, 10 degrees finger extension ( Criteria for CIMT)
5. GMFCS (Gross Motor Function Classification System) level I, II and III
LEVEL I -Walks without Limitations
LEVEL II - Walks with Limitations
LEVEL III – Walks using a Hand-Held Mobility Device
(GMFCS - E & R- CanChild Centre for Childhood Disability Research, McMaster University)
6. Spasticity Grade 0, 1 and 1+ according to Modified Ashworth scale.
7. Able to understand and follow commands.
|
|
| ExclusionCriteria |
| Details |
1. Visual or auditory impairments.
2. Previous orthopedic surgery in affected upper limb.
3. Fixed upper limb deformities.
4. Botulinum toxin injections in upper limb within last 6 months.
5. Neurological or orthopedic conditions unrelated to cerebral palsy.
6. Epilepsy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| QUEST ( Quality of Upper Extremity Skills Test) |
Baseline
At the end of 2 weeks
At the end of 4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
15/03/2023 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a three arm parallel group randomized clinical trial. The three interventions i.e. mCIMT, Mirror therapy & HABIT are established interventions for improving upper extremity function in children with hemiplegic cerebral palsy. In this study we aim to find the best intervention for improving upper extremity function by using QUEST |