Treadmill Training Effects on Cardiorespiratory Endurance and Constipation in Children With Cerebral Palsy

NCT06480448 | Completed

• 1 other identifier: RIPHAH/FR&AHS/letter-01826
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the impact of treadmill training on cardiorespiratory endurance and constipation in children with cerebral palsy (CP). Treadmill training is evaluated for its potential to improve cardiovascular fitness and alleviate constipation through its rhythmic movements. The findings shed light on the broader health benefits of treadmill interventions beyond motor function improvement in children with CP

Conditions

Cardiopulmonary

Keywords

motor function

Outcome Measures

Primary Outcomes (5)

• Constipation Assessment Scale (CAS)

  One commonly used tool for assessing constipation in children is the "Rome IV Criteria," which is part of the Rome IV diagnostic criteria for functional gastrointestinal disorders. These criteria provide a standardized framework for diagnosing constipation based on specific symptoms and duration requirements

  Baseline - 12th Week

• 6-mintues walk test

  The 6-Minute Walk Test (6MWT) is a standardized assessment used to measure a person's functional exercise capacity and endurance. During the test, individuals are instructed to walk as far as they can within a six-minute period along a flat, straight course. The test is typically conducted in a corridor or along a marked pathway, and the distance covered is recorded at the end of the test. Before the test begins, participants receive instructions on the procedure and are given the opportunity to ask questions. Baseline measurements such as heart rate, blood pressure, and oxygen saturation may be taken. Participants are encouraged to walk at a self-selected pace, and they are allowed to rest if needed during the test. However, the timer continues to run during rest periods.

  Baseline - 12th Week

• Heart Rate

  The number of pulses over a minute is the standard heart rate measurement. This can also be calculated by doubling the number of pulses felt over 30 seconds.

  Baseline - 12th Week

• VO2 Max

  VO2 max, or maximal oxygen consumption, refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. This measurement is generally considered the best indicator of cardiovascular fitness and aerobic endurance.

  Baseline - 12th Week

• Respiratory Rate

  Baseline - 12th Week

Study Arms (2)

Traditional physical therapy

EXPERIMENTAL

This group will only getting conventional therapy which include core stability training, strength training, gait training through Parallel bar etc.

Other: Traditional physical herapy

Treadmill training

ACTIVE COMPARATOR

This group will getting treadmill training will be started along with conventional therapy group. Training protocol will be standardized and follow FITT protocol for 12 weeks.

Other: Treadmill training

Interventions

Traditional physical herapy OTHER

core stability, strengthening exercises, stationary bicycle training and sustained strechinng exercises.

Traditional physical therapy

Treadmill training OTHER

Treadmill training for 20 minutes three time a week.

Treadmill training

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 to 12 years.
• Children having 1, or 2 on GMFCM.
• Children with spastic diplegic cerebral palsy.
• Children with well cognitive behavior.
• Children having 1 to 2 level on constipation assessment scale.
• Defecation frequency less than 3 time a week.

You may not qualify if:

• Misdiagnosed or not conform to Cerebral palsy.
• Children should be medically stable uncontrolled seizures.
• The children with mental retardation or other neurological disorders.
• Children with taking medication like muscle relaxant or laxative

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rehman Medical Institute

Peshawar, Punjab Province, 46000, Pakistan

Location

Study Officials

• Waqar Ahmed Awan, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: June 28, 2024
• Study Start: April 28, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)