NCT07136129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 10, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

cerebral palsyOne-Minute Sit-to-Stand TestFunctional Exercise Performance in Cerebral PalsySix-Minute Walk Test

Outcome Measures

Primary Outcomes (2)

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

    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.

    At baseline (single assessment session)

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

    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.

    At baseline (single assessment session)

Secondary Outcomes (4)

  • 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

Study Arms (1)

Spastic hemiplegic type SP

Individuals between 5 and 18 years of age, diagnosed with spastic hemiplegic type CP and in level I or II according to the Gross Motor Function Classification System (GMFCS) were included.

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of children aged between 5 and 18 years who were diagnosed with spastic hemiplegic type cerebral palsy (CP) and were being followed up at the Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital between December 2024 and July 2025. These individuals were classified as Level I or II according to the Gross Motor Function Classification System (GMFCS), indicating relatively high levels of functional mobility. All participants and their legal guardians were informed about the study's purpose and procedures, and written informed consent was obtained. The study was approved and conducted in accordance with the principles of the Declaration of Helsinki.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asistant

Study Record Dates

First Submitted

July 10, 2025

First Posted

August 22, 2025

Study Start

December 31, 2024

Primary Completion

March 1, 2025

Study Completion

July 1, 2025

Last Updated

August 22, 2025

Record last verified: 2025-07

Locations