Effects of Stationary Cycling and Progressive Functional Training in Cerebral Palsy Children

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Progressive Functional Training; Other: Stationary Cycling

• Registration Number: NCT06198153
• Lead Sponsor: Riphah International University

Brief Summary

Cerebral palsy is not a progressive disease but movement problem and musculoskeletal disorders in cerebral palsy change with time. Children with CP usually with the lower limb involvement presents with muscle weakness, limited muscular control which results in muscular insufficiency, coordination and balance impairment. These impairments effect the normal activities of child in daily living. There are many children who have good cognition but poor lower limb coordination which is leading cause of disability in them and multiple factors are responsible for them like lake of awareness in parents, no time, expensive therapy program and inappropriate techniques.

Detailed Description

The study will be randomized clinical trial and will be conducted in Bahawalpur. The study will be completed in time duration of 6 months after approval of synopsis. Non probability convenience sampling technique will be used and 22 children will be recruited in the study meeting the inclusion criteria. The participants will be divided into two groups through randomization using lottery method. Group A will perform 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks. While group B will be given progressive functional training 3 times a week for 10-15 minutes for 6 weeks. Pediatrics balance scale will be used to measure functional balance skills and GMFS scale will be used to measure gross motor function. The data will be assessed at the baseline and after 6 weeks of intervention. After data collection data will be analyzed by using SPSS version 25.

Study Timeline

• Study Start: 2023-11-28
• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-10
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• • Children with cerebral palsy (Hemiplegic)

  • Age: 4 to 10 years
  • Able to sit without foot or arm support
  • Children with level I & II on Gross motor function classification system
  • Normal cognitive function; can understand and follow command

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Exclusion Criteria

• • Children with mental retardation.

  • Visual and auditory disorders.
  • History of any surgical procedure.
  • Any infections, unstable seizures, etc.
  • Fixed deformities or contractures of lower limbs.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive Functional Training	Progressive Functional Training	This group will receive Progressive Functional Training programs for 6 weeks.
Stationary Cycling	Stationary Cycling	This group will receive stationary cycling for 6 weeks.

Primary Outcome Measures

Name	Time	Method
GMFM Scale	6weeks	The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. (13) However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item.; Scoring Key: 0= does not initiate; 1. initiates; 2. partially completes; 3. completes 9 (or leave blank) = not tested (NT) \[used for the GMAE-2 scoring\*\] It is important to differentiate a true score of -0‖ (child does not initiate) from an item which is Not Tested (NT) if you are interested in using the GMFM-66 Ability Estimator (GMAE) Software. It is reliable with 95% confidence interval=0.965-0.994. The validity with 95% confidence interval=0.972-0.997
Pediatrics Balance Scale	6 weeks	The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. (15) The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points Reliability testing performed with a sample of 20 children ages 5-15 years old with mild to moderate motor impairments showed good test-retest reliability (ICC=0.998) and good interrater reliability (ICC=0.997).

Trial Locations

Locations (1)

Imran Amjad; 🇵🇰 Lahore, Punjab, Pakistan