Skip to main content
Clinical Trials/CTRI/2024/06/068678
CTRI/2024/06/068678
Not yet recruiting
Phase 2

Effect of Backward Walking Training on Balance and Walking Distance in children with Cerebral Palsy A Randomized Controlled Trial

Sonal Choudhary Seth GS Medical College and KEM Hospital1 site in 1 country42 target enrollmentStarted: June 20, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Sonal Choudhary Seth GS Medical College and KEM Hospital
Enrollment
42
Locations
1
Primary Endpoint
Balance by pediatric Balance scale

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
5.00 Day(s) to 12.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • Gross Motor Functional Classification 1 & 2 Mini mental Scale for children cut off score 24.

Exclusion Criteria

  • Seizures in the past 6 months Recent lower limb surgeries Recent botulinum toxin injection.

Outcomes

Primary Outcomes

Balance by pediatric Balance scale

Time Frame: At baseline, 4 weeks

Secondary Outcomes

  • Walking distance by 1 minute walk test(At baseline, 4 weeks)

Investigators

Sponsor
Sonal Choudhary Seth GS Medical College and KEM Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Archana Gore

Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai

Study Sites (1)

Loading locations...

Similar Trials