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

Cerebral Palsy Clinical Trial

Official title:

Comparative Effects of Stationary Cycling and Progressive Functional Training on Balance and Motor Control of Lower Extremity in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06198153
• Other study ID #: REC/RCR&AHS/23/0751
• Status: Completed
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 29, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Stationary Cycling
In addition to the conventional physical therapy, children in this group will receive 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks.
• Progressive Functional Training
In addition to the conventional physical therapy, the training will follow a 6-week progressive functional training program for lower extremities. These exercises will include sit-to-stand exercise, lateral/forward step-up exercise (i.e. climbing a stair or stepping up onto a kerb), and half-knee rise exercise (i.e. rising from the ground). All exercises will be performed in 1-3 sets of 10-15 repetitions, with a 90 second rest in between the sets. Each exercise will be performed within 10-15 minutes. Training session will be given 3 times a week. During the training, intensity will be progressively increased by increasing the repetitions

Locations

Country	Name	City	State
Pakistan	Imran Amjad	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMFM Scale	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; initiates; partially completes; 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	6weeks
Primary	Pediatrics Balance Scale	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).	6 weeks