| CTRI Number |
CTRI/2022/01/039696 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
21/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Physiotherapy for cerebral palsy |
|
Scientific Title of Study
|
Comparison of the efficacy of Hand Arm Bimanual Intensive Therapy (HABIT) versus modified constraint induced movement therapy (mCIMT) in children with hemiparetic cerebral palsy aged 5-18 years: an open labelled randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRATEEK KUMAR PANDA |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
Dept of Pediatrics, 6th Floor, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRATEEK KUMAR PANDA |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
Dept of Pediatrics, 6th Floor, AIIMS, Rishikesh
UTTARANCHAL
249201
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATEEK KUMAR PANDA |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
Dept of Pediatrics, 6th Floor, AIIMS, Rishikesh
UTTARANCHAL
249201
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| PRATEEK KUMAR PANDA |
AIIMS, Rishikesh |
6th Floor, Department of Pediatrics, AIIMS, Rishikesh, Pin-249201
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand arm bimanual intensive therapy |
the duration of intervention will be for 8 weeks. Instead of using physical restraint, participants will be engaged in age-appropriate fineand
gross-motor bimanual activities using motor learning approaches. Activities will be selected
by considering the role of the paretic hand, increasing in complexity from a nondominant passive
assist (eg, stabilizing paper while drawing) to active manipulator (eg, reorienting paper while
cutting) using increasingly complex bimanual coordination and participants’ interests. Task
demands will be graded, and participants will be engaged in active problem solving.
Interventionists will avoid verbal prodding to use the paretic hand and instead constrain the
environment by providing tasks necessitating the use of both hands to elicit desired movements.
Part practice will include both bilateral symmetrical (eg, reaching toward objects with both hands)
and asymmetrical (eg, pulling apart objects) movements. |
| Intervention |
modified constraint induced movement therapy |
An arm sling will be used for restraint of the non affected limb and will be worn only
during the intervention (arm sling will be provided free of cost to the children in both the groups).
The children will be provided structured intervention in a child friendly atmosphere. During the 2
hour intervention period, they will be constantly given the instructions involving the specific
practice of the designated task movement by the affected, unrestrained extremity. They will be
made to perform various repetitive and shaping activities of practicing a target movement in
isolation of other movements in the given time frame. Successively the difficulty of the tasks
would be increased on completion of a particular task and would be given constant reinforcement
throughout the session. A specific and individualized exercise plan will be provided at every
session to be practiced at home for 2 hours a day. Duration of the intervention will be for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged >5-18 years with hemiparetic cerebral palsy
2.IQ >70 |
|
| ExclusionCriteria |
| Details |
Contractures of the affected limb |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in upper limb function of the hemiparetic side in both groups as compared to baseline as measured by Quality of Upper Extremity Skills Test (QUEST) |
At baseline (week 0) and at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life in both groups as compared to baseline by PedsQL TM (Pediatric Quality of Life Inventory TM) |
At baseline (week 0) and at 8 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/01/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study tends to explore a relatively less explored rehabilitation modality, albeit highly promising in preliminary studies i.e. hand arm bimanual intensive training as an equivalent and less restrictive, more acceptable alternative to modified CIMT for children with hemiparetic cerebral palsy. If found successful, this will generate level I evidence in this regard and is likely to change the management of children with hemiparetic cerebral palsy favourably in upcoming years. The design of the study is open label RCT. The participant will receive either modified CIMT or HABIT for 8 weeks. |