Clinical Trials Directory

Trials / Completed

CompletedNCT07136129

Functional Exercise Performance in Children With Cerebral Palsy: Is the One-Minute Sit-to-Stand Test an Alternative to the Six-Minute Walk Test

Status
Completed
Phase
Study type
Observational
Enrollment
78 (actual)
Sponsor
Inonu University · Academic / Other
Sex
All
Age
5 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This study investigates the validity of the 1-minute sit-to-stand test (1MSTS) as a practical and time-efficient alternative to the 6-minute walk test (6MWT) for assessing functional exercise capacity in children with spastic cerebral palsy (CP). Children aged 5 to 18 years with spastic hemiplegic CP, classified as Level I or II according to the Gross Motor Function Classification System (GMFCS), will perform both tests on the same day. Cardiopulmonary responses and fatigue will be monitored before and after each test. The study aims to determine whether the 1MSTS can be reliably used in clinical settings as a simpler assessment tool for this population.

Detailed description

This cross-sectional study was conducted between December 2024 and July 2025 at Kayseri City Hospital with children diagnosed with spastic hemiplegic cerebral palsy, aged 5-18 years, classified as Level I or II on the Gross Motor Function Classification System (GMFCS). Children with severe cognitive impairment, additional neurological disorders, or uncontrolled health conditions were excluded. Participants completed both the 6-minute walk test (6MWT) and the 1-minute sit-to-stand test (1MSTS) on the same day, in random order. Tests were performed twice, and a 1-hour rest was given between them. Cardiovascular and respiratory parameters (heart rate, oxygen saturation, blood pressure), dyspnea, and leg fatigue were measured before and after each test using standard tools (pulse oximeter, sphygmomanometer, Modified Borg Scale). The 6MWT followed ATS guidelines. The 1MSTS was performed using a height-adjustable chair without armrests, and participants stood up and sat down repeatedly for one minute. The number of completed repetitions was recorded. This study followed the Declaration of Helsinki, and written informed consent was obtained from all participants and their guardians.

Conditions

Timeline

Start date
2024-12-31
Primary completion
2025-03-01
Completion
2025-07-01
First posted
2025-08-22
Last updated
2025-08-22

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07136129. Inclusion in this directory is not an endorsement.