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NCT Number: NCT07136129

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Spastic Hemiplegic Nervous System Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Heart Rate (HR) Before and After Exercise Tests

    Time frame: Pre-intervention and immediately after the intervention

    Heart rate is measured using a pulse oximeter before and after both the 1MSTS and 6MWT to assess cardiovascular response to physical activity.

  2. Oxygen Saturation (SpO2) Before and After Exercise Tests

    Time frame: Pre-intervention and immediately after the intervention

    Peripheral oxygen saturation is recorded before and after each exercise test to monitor oxygenation changes in response to activity.

  3. Systolic and Diastolic Blood Pressure Before and After Exercise Tests

    Time frame: Pre-intervention and immediately after the intervention

    Blood pressure values are recorded before and after the tests using a standard sphygmomanometer to evaluate cardiovascular load.

  4. Perceived Dyspnea and Leg Fatigue Using Modified Borg Scale

    Time frame: Pre-intervention and immediately after the intervention

    Dyspnea and lower extremity fatigue are assessed before and after each test using the Modified Borg Scale (0-10), which evaluates subjective exertion levels.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Collaborators

  • Kayseri University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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