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CTRI Number  CTRI/2021/09/036429 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On: 15/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Occupational therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Control Trial to Compare the Efficacy of Caregiver Directed Home Based HABIT With and Without Tele-rehabilitation in Cerebral Palsy Children 
Scientific Title of Study   A Randomized Control Trial to Compare the Efficacy of Caregiver Directed Home Based HABIT With and Without Tele-rehabilitation in Cerebral Palsy Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gita Handa 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of Physical Medicine and Rehablitation, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone  9899664489  
Fax    
Email  gitahanda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gita Handa 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of Physical Medicine and Rehablitation, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi South DELHI 110029 India


DELHI
110029
India 
Phone  9899664489  
Fax    
Email  gitahanda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Veluguleti Ujwal 
Designation  Junior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of Physical Medicine and Rehablitation, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone  9581881995  
Fax    
Email  veluguletiujwal@gmail.com  
 
Source of Monetary or Material Support  
Department of Physical Medicine and Rehablitation, All India Institute Of Medical Sciences  
 
Primary Sponsor  
Name  Dr Gita Handa 
Address  Department of Physical Medicine and Rehablitation, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi South DELHI 110029 India  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gita Handa  AIIMS, Ansari Nagar,New Delhi-110029  Department of Physical Medicine and Rehablitation, Academic block,All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi South DELHI 110029 India
South
DELHI 
9899664489

gitahanda@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee,AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Home based Hand Arm Bimanual Therapy (H-HABIT) with Telerehablitation  Home based Hand Arm Bimanual Therapy (H-HABIT) supervised by caregiver for a total of 9 weeks (90 hours) at home with additional Tele Rehab follow ups at 2 weeks, 4 weeks, 6 weeks and 8 weeks 
Comparator Agent  Home based Hand Arm Bimanual Therapy (H-HABIT) without Telerehablitation  Home based Hand Arm Bimanual Therapy (H-HABIT) supervised by caregiver for a total of 9 weeks (90 hours) 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1) Children with cerebral palsy between 6 years and 18 years.
2) Ability to actively grasp an object on table with affected hand.
3) Ability to follow two-step instructions and complete testing. (Child can listen and follow the command)
4) Caregiver to provide one-to-one attention to the child during home training activities.
5) To score grades of 2 to 4 on MACS grading, and 1 to 4 on GMFCS.
6) Ability to use devices smart phone, desktop and make video call by parent. 
 
ExclusionCriteria 
Details  1) Child unable to follow two-step instructions.
2) Normal upper limb function, Grade 1in MACS.
3) Visual problems preventing performance of intervention/testing tasks.
4) Caregivers unable to attend the entire duration of intervention.
5) Non-availability of the caregiver.
6) Botoulinum toxin injection in the upper limb in past 6 months. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To compare the manual ability (ABILHAND-Kids) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children.  baseline at 0week, 9 and 12 weeks of follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare the manual ability (MACS) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children. 2) To compare the gross motor function (GMFCS E&R) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children. 3) To compare family burden using Family burden questionnaire of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children.  baseline at 0week, 9 and 12 weeks of follow up. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/09/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Cerebral palsy (CP) is a group of permanent, but often changing disorders of movement and or posture motor function, which are due to a non-progressive lesion or abnormality of the developing immature brain(1).Worldwide incidence range between 2 and 2.5 per 1000 live births(2). Prevalence of CP in India ranges between 21 to 173 per 100 (3). The etiology of CP is multifactorial and it can be injury to developing brain during prenatal ,natal and post natal eg:-congenital, genetic, inflammatory ,infectious, anoxic, traumatic and metabolic(4). Some authors recommended to use a simplified classifications like unilateral or bilateral with indicating upper limb or lower limb is involvement(5).CP can be classified according to topography and tone. Topographically, they are classified as monoplegia, hemiplegia, quadriplegia and diplegia(2). By tone, CP is classified into spastic, hypotonic, mixed, ataxic and dyskinetic (2) .
The comorbidities associated with CP include speech and language disorders, intellectual disability, visual disability, hearing disability, motor impairment and epilepsy(6).
For assessing the level of physical ability, various tools can be used. The commonly used measures are Gross Motor Function Classification System (GMFCS) for gross motor and Manual Ability Classification System (MACS) for hand functions in Cerebral Palsy children. GMFCS & MACS enable health professionals to quantify motor function and manual ability, establish therapeutic goals and improve the communication with relatives or caregivers(7). The children who can ambulate with or without assistive devices categorized under the first three GMFCS levels(8).Other scales like functional mobility(FMS) scale are also used. Mobility is rated for three distances in this scale representative of the home (5 m), school (50 m), and community (500 m) settings. These distances were chosen based on clinical judgment and are used as a guide, not as the exact same distances. For each distance a rating of 1–6 is given depending on the assistance or help required, ranging from wheelchair (1) to independent without devices on all surfaces (6).(9)
CP causes lots of challenges to not only the affected persons but also the family, which can be economical, psychological and social especially in low and middle income settings. Most of the time therapies for CP children are provided by trained therapists at specified centres, which add to the burden of caregivers. So caregiver driven home based rehabilitation is more appropriate.
Greater than 80% of children with CP have an upper extremity involvement, which can significantly affect the child’s activities of daily living (ADL) and quality of life. Due to damage to the motor cortex and corticospinal tract, children with CP faces difficulties in precise grasping and fine motor control and can develop an abnormal movement of hand (10).
Rehabilitation literature review indicates that the most effective interventions in CP children are motor learning-based interventions delivered at high intensity and which focus on function(11). One of such intensive therapy studied extensively is constraint-induced movement therapy (CIMT). Recent evidence has shown that children with CP could benefit from CIMT for unimanual hand ability. CIMT focuses on the practice and exercises of the involved hand, and it restrains the use of the non-involved hand during treatment (focuses only on the affected hand). This may be not practical for children to perform ADL, since most ADL tasks require use of two hands working together for activities such as opening bottles, dressing etc. Bimanual therapy is a general term for repetitive task practice using both the hands, rather than one hand, to complete functional activities. It is a child-friendly technique without the physical constraint of the less-affected hand (10).
Hand-arm bimanual intensive therapy (HABIT) is a form of intensive bimanual child friendly training effective in improving the amount and quality of involved upper-extremity use. HABIT is an example of such intensive therapy. In HABIT affected hand or most affected hand used as assisting hand in intervention(11).
The HABIT involves prioritization of the bimanual coordination skills of hands, and it also maintains the intensive quality of constraint therapy. The structured practice includes two specific types: one is the whole-task practice (e.g.,
performing the activity for at least 15 to 20 minutes) and the other is the part-task practice (e.g., practicing target movements repeatedly) (9).
Tele-rehabilitation is defined as the set of instruments and protocols aimed at prescribing rehabilitation at a distance. This can be an appropriate strategy to address health issues in low and middle-income countries and remote areas with limited access rehabilitation centre (12). Tele-rehabilitation benefits the children with physical disabilities to be in contact with their rehabilitation specialist, and maintain improvements, and it could simultaneously reduce the burden on parents.

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