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

NCT06198153 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0751
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

: Balance, Cerebral palsy, Cycling,; Motor control; Functional training,

Outcome Measures

Primary Outcomes (2)

• 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 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

  6weeks

• 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

Study Arms (2)

Stationary Cycling

ACTIVE COMPARATOR

This group will receive stationary cycling for 6 weeks.

Other: Stationary Cycling

Progressive Functional Training

EXPERIMENTAL

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

Other: Progressive Functional Training

Interventions

Stationary Cycling 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.

Stationary Cycling

Progressive Functional Training 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

Progressive Functional Training

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

  PMID: 34158790 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Aneeza Maryam, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: November 28, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 29, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)