| CTRI Number |
CTRI/2024/06/068678 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Backward walking training for cerebral palsy |
|
Scientific Title of Study
|
Effect of Backward Walking Training on Balance and Walking Distance in children with Cerebral Palsy A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
Opd number - 402, physiotherapy school and Centre , Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Choudhary |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
Opd no - 402, physiotherapy school and Centre , Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9167666028 |
| Fax |
|
| Email |
sonal.choudhary10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
Opd no - 402, physiotherapy school and Centre , Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg Parel, Mumbai - 400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Sonal Choudhary Seth GS Medical College and KEM Hospital |
| Address |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg Parel, Mumbai - 400012, Maharashtra, India |
| Type of Sponsor |
Government medical college |
|
|
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 Archana Gore |
Seth G. S. Medical College and KEM Hospital, Mumbai |
Opd number - 402, physiotherapy school and Centre , Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA |
9082621220
nilarch17@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Seth G.S. Medical College and KEM HospitalHospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Backward Walking Training with Conventional Therapy |
Backward walking training for 20 mins excluding rest periods for 8 sessions along with 40 mins of Conventional therapy |
| Comparator Agent |
Conventional Therapy |
1 hour of Conventional treatmentfor cerebral palsy for 8 sessions which would include Active stretching program for muscles around ankle, hip, knee, trunk. Postural stability training, sit to stand exercises, strengthening exercises, balance training, gait training. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Day(s) |
| Age To |
12.00 Day(s) |
| Gender |
Both |
| Details |
Gross Motor Functional Classification 1 & 2
Mini mental Scale for children cut off score 24 |
|
| ExclusionCriteria |
| Details |
Seizures in the past 6 months
Recent lower limb surgeries
Recent botulinum toxin injection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance by pediatric Balance scale |
At baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Walking distance by 1 minute walk test |
At baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/06/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Backward walking training (BWT) includes supervised gait training on the ground without obstacles in the backward direction. This study aims to evaluate the effect of BWT on the balance and walking distance of children with cerebral palsy (CwCP). The outcome measures are paediatric balance scale (PBS) for balance and 1 minute walk test (1MWT) for assessing walking distance. It is a randomised controlled trial in which control group will receive conventional therapy (60 mins) and experimental group will receive BWT (20 mins) along with conventional therapy (40 mins) for 8 sessions over a period of 4 weeks. CwCP (aged 5-12 years) will be recruited from the paediatric physiotherapy OPD of tertiary health care centre. It will be an all-inclusive study in which all children coming to the set-up and fitting into the inclusion criteria will be included as sample size. Informed consent documents will be obtained from the parents and assent will be obtained from the children. The children will be randomly assigned to two groups using the coin flipping method. Pre intervention outcome measures will be taken. Both groups will receive assigned therapeutic intervention. Post intervention outcome measures will be taken after 8 sessions. This will be assessor blinded. The results will be statistically analysed. Intergroup analysis, depending on normality, will be done using independent T-test (Parametric) or Mann-Whitney (non parametric) to compare paediatric balance scale scores and one minute walk distance between control group and interventional group. Depending on normality, Paired T test (parametric) or Wilcoxon Signed Rank Test (non parametric) will be used to compare Paediatric balance scale score and One minute walk distance for intragroup analysis. |