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CTRI Number  CTRI/2021/06/034399 [Registered on: 25/06/2021] Trial Registered Prospectively
Last Modified On: 23/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON BETWEEN ROBOTIC BIOFEEDBACK- BASED UPPER LIMB REHABILITATION AND CONVENTIONAL PHYSIOTHERAPY IN CHILDREN WITH HEMIPLEGIC CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL 
Scientific Title of Study   A Pilot Study to evaluate the efficacy of Robotic Biofeedback-based upper limb rehabilitation in children with Hemiplegic Cerebral Palsy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyotindra Narayan Goswami 
Designation  Associate Professor 
Affiliation  Army Hospital Research & Referral 
Address  Department of Pediatrics Army Hospital Research and Referral Delhi Cantonment
P 18 Army Hospital Research and Referral Delhi Cantonment
South West
DELHI
110010
India 
Phone  8727993888  
Fax    
Email  jngswami@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jyotindra Narayan Goswami 
Designation  Associate Professor 
Affiliation  Army Hospital Research & Referral 
Address  Department of Pediatrics Army Hospital Research and Referral Delhi Cantonment
P 18 Army Hospital Research and Referral Delhi Cantonment

DELHI
110010
India 
Phone    
Fax    
Email  jngswami@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jyotindra Narayan Goswami 
Designation  Associate Professor 
Affiliation  Army Hospital Research & Referral 
Address  Department of Pediatrics Army Hospital Research and Referral Delhi Cantonment
P 18 Army Hospital Research and Referral Delhi Cantonment
South West
DELHI
110010
India 
Phone  8727993888  
Fax    
Email  jngswami@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical Research Committee Government of India 
 
Primary Sponsor  
Name  Armed Forces Medical Research Cell 
Address  Armed Forces Medical research Cell Office of DGAFMS New Delhi:110001 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vishal Sondhi  Armed Forces Medical College  Department of Pediatrics Armed Forces Medical College Old Sholapur Road Pune
Pune
MAHARASHTRA 
9560664032

rtmsproject@rediffmail.com 
Jyotindra Narayan Goswami  Army Hospital Research and Referral  Department of Pediatrics Army Hospital Research and Referral Delhi Cantonment
South West
DELHI 
8727993888

jngswami@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC Army Hospital Research and Referral Delhi Cantonment  Approved 
Institutional Ethics committee Armed Forces Medical College Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  (a) Exercises to improve gross motor functions of affected upper limb (b) Exercises to improve fine motor functions of affected upper limb (c) Constraint induced movement therapy (d) Range of movement activities (e) Occupational therapy activities such as peg board. Duration per session : 30 minutes Frequency of sessions: Thrice weekly ; Total duration of therapy : 12 months  
Intervention  robotic biofeedback based rehabilitation programme for upper limb   (a)The device can be used to provide goal directed movement training for entire upper limb with movements at shoulder, elbow ,wrist and finger joints. (b)Audio-visual feedback would be provided for fine-tuning the movements. (c) The device can be used to measure hand-grip strength Duration per session : 30 minutes Frequency of sessions: Thrice weekly Total duration of therapy : 12 months  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details 
Children of either sex aged 5 to 18 years clinically diagnosed to have hemiplegic cerebral palsy

Gross Motor Functional Classification System Score or GMFCS Score either I to III

Minimum visual acuity of 6/60

Ability to follow simple single step commands

Either parent should be willing and capable of following instructions and maintaining activity log
 
 
ExclusionCriteria 
Details  Children who have received botulinum toxin injection in upper limb in the past one year prior to enrolment

Children who have undergone orthopaedic corrective surgery in the past one year prior to enrolment

Children with concomitant chronic systemic illnesses that can interfere with execution of intervention or physiotherapy

Children with any acute illness that can interfere with execution of intervention or physiotherapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of robotic biofeedback based rehabilitation for upper limb with that of conventional physiotherapy in 5to 18 year old children and adolescents with hemiplegic CP with Gross Motor Function Classification Scale Scores between I to III as measured by change in grip strength of affected hand at one year of initiation of therapy  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change in following scores between 5 to18 year old children and adolescents with hemiplegic CP with GMFCS I to III receiving robotic biofeedback based rehabilitation for one year with those receiving conventional physiotherapy for one year

Quality of Upper Extremity Skills Test Scores or QUEST scores at 12 months and 15 months of initiation of therapy

Grip strength of affected upper limb at 15 months of initiation of therapy
 
12 months and 15 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2021 
Date of Study Completion (India) 30/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2022 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Cerebral palsy (CP) is a common neurodevelopmental  disorder of childhood, occurring secondary to a static insult to the developing fetal or infant brain (1).The worldwide prevalence of CP is 2 to 2.5 per1000 live births (1). Hemiparetic CP comprises of about one third of the total cases of CP (2).The incidence of hemiparetic CP in North India is noted to be 13.8% among all CP children (3). Multiple forms of physical therapy are practised for CP rehabilitation , each one having its unique pros and cons (4).Existence of these different schools of therapy indicates the absence of a universally effective management technique in CP.

Biofeedback-based therapy is a recent concept wherein children with CP are allowed to  interact with virtual events that motivate them to perform certain movements and undergo motor rehabilitation (5).Activity based therapy and robot assisted rehabilitation are two other contemporary concepts in rehabilitation.Activity based therapy utilizes the principle of neuroplasticity whereby functional rehabilitation is achieved through repetitive performance of activities(6). Robotic upper limb rehabilitation is the technique of  application of computer-controlled robotic devices for  goal directed task-specific functioning (7). Biofeedback is the provision of external sensory inputs about a particular movement or action that is being done during rehabilitation (8).Biofeedback  keeps the patient motivated and engaged in structured activity as well as provides real-time inputs for corrective action/modification of his or her action (9).Though there have been reports of positive effects of  robotic rehabilitation in children with CP, there is nouniversally accepted common protocol related to the technique  Current literature review does not mention any Indian trial on robotic rehabilitation in hemiparetic CP. Hence this is a novel research area.

CP is commonly encountered not only in the pediatric out-patient departments(OPD) of our service hospitals but also in Neurology OPDs since increasing number of these children are transitioning to adult care owing to standardized medical practices. Robotic upper limb rehabilitation with biofeedback appears promising in this regard in being a novel, effective,feasible,user-friendly  therapeutic regimen  which may revolutionize rehabilitation medicine. All children enrolled in the study shall receive physical therapy and hence , would be benefitted. T-lhe therapy is highly unlikely to cause any adverse effects to the patients other than the extremely rare known risks of physical therapy, the chances of occurrence of which would be remote as the programme would be supervised by a certified physical medicine and rehabilitation specialist. If found effective, mass scale implementation of this therapeutic model in our hospitals as well as  rehabilitation centres would be suggested ,which would prove economical in the long run .

 
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