| 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 |
|
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Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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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
|
|
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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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 . |