Effect of Backward Walking Training on Balance and Walking Distance in children with Cerebral Palsy A Randomized Controlled Trial
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
Dr Archana Gore
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai