Clinical trial NCT06198153: Effects of Stationary Cycling and Progressive Functional Training in Cerebral Palsy Children
Official title: Comparative Effects of Stationary Cycling and Progressive Functional Training on Balance and Motor Control of Lower Extremity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: : Balance, Cerebral palsy, Cycling,
Motor control
Functional training,
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: GMFM Scale
timeFrame: 6weeks
measure: Pediatrics Balance Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Imran Amjad
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aneeza Maryam, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ansa OEO, Mprah KW, Moses MO, Owusu I, Acheampong E. Effect of Community-Based Functional Aerobic Training on Motor Performance and Quality of Life of Children with Spastic Cerebral Palsy. Ethiop J Health Sci. 2021 Mar;31(2):381-392. doi: 10.4314/ejhs.v31i2.21.