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Clinical Trials/NCT07136129
NCT07136129CompletedNot Applicable

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

Inonu University1 site in 1 country78 target enrollmentStarted: December 31, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78
Locations
1
Primary Endpoint
Number of Repetitions in the 1-Minute Sit-to-Stand Test (1MSTS)

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
5 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Having spastic hemiplegic CP between 5-18
  • Being level 1 and 2 according to KMFSS

Exclusion Criteria

  • Having cognitive/mental problems at a level that may prevent communication
  • Having genetic and/or neurological problems in addition to CP
  • Having uncontrolled heart disease
  • Having any infection Removal Criteria
  • The child or his/her parents wanting to leave the study
  • Failure to complete the tests to be applied within the scope of the study
  • Having an additional disease/surgical operation during the study

Outcomes

Primary Outcomes

Number of Repetitions in the 1-Minute Sit-to-Stand Test (1MSTS)

Time Frame: At baseline (single assessment session)

This outcome measures the total number of full sit-to-stand movements performed in one minute by participants with spastic hemiplegic cerebral palsy. The aim is to determine whether the 1MSTS is a valid measure of functional exercise performance in this population.

Distance Walked in the 6-Minute Walk Test (6MWT)

Time Frame: At baseline (single assessment session)

Measures the total distance (in meters) walked in 6 minutes by participants on a 30-meter corridor, in accordance with ATS guidelines. The 6MWT serves as the reference test to compare with the 1MSTS.

Secondary Outcomes

  • Heart Rate (HR) Before and After Exercise Tests(Pre-intervention and immediately after the intervention)
  • Oxygen Saturation (SpO2) Before and After Exercise Tests(Pre-intervention and immediately after the intervention)
  • Systolic and Diastolic Blood Pressure Before and After Exercise Tests(Pre-intervention and immediately after the intervention)
  • Perceived Dyspnea and Leg Fatigue Using Modified Borg Scale(Pre-intervention and immediately after the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Betul Ergun

research asistant

Inonu University

Study Sites (1)

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