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

NCT ID: NCT06198153

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2024-01-29

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stationary Cycling

This group will receive stationary cycling for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Stationary Cycling

Intervention Type: OTHER

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

This group will receive Progressive Functional Training programs for 6 weeks.

Group Type: EXPERIMENTAL

Progressive Functional Training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aneeza Maryam, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Imran Amjad

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 34158790 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0751

Identifier Type: -

Identifier Source: org_study_id