NCT05962749

Brief Summary

Children aged between 6-18 years old, diagnosed with cerebral palsy and meeting the inclusion criteria, will be included in this study. All children and their parents who agree to participate in the study will be informed about the study and will be required to sign an "Informed Consent Form" indicating their voluntary participation. To evaluate gait, the 3-Meter Backward Walking Test (3MBWT) and the 10-Meter Walk Test (10MWT) will be performed on a flat. The Selective Control Assessment of the Lower Extremity (SCALE) will be used to assess selective motor control in the lower extremity (hip, knee, ankle, subtalar, and toe joints). To evaluate trunk control, the Trunk Control Measurement Scale (TCMS) will be applied in a sitting position. For balance assessment, the Pediatric Balance Scale will be used to reflect activities of daily living. To assess functional independence, the Pediatric Functional Independence Measure (WeeFIM) will be applied. The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

July 19, 2023

Last Update Submit

November 6, 2024

Conditions

Keywords

Cerebral PalsyBackward WalkingSelective Motor ControlTrunk ControlBalance

Outcome Measures

Primary Outcomes (2)

  • 3 meter backward walk test (3MBWT)

    The 3-Meter Backward Walk Test (3MBWT) measures the time it takes for a person to walk 3 meters backward. This test assesses balance, coordination, and leg strength, making it especially useful for individuals at risk of falling or those with neurological issues. During the test, the participant is timed while walking backward over a flat 3-meter distance. Completing the distance quickly and safely indicates good balance and backward walking ability, while taking longer may suggest potential issues with balance or motor control. This simple yet effective test is used in clinical settings to evaluate functional mobility and monitor progress over time.

    First day

  • 10 meter walk test (10MWT)

    The 10-Meter Walk Test (10MWT) measures the time it takes for a person to walk a distance of 10 meters at their comfortable walking pace. This test is widely used to assess walking speed, gait, and functional mobility, and it can be particularly beneficial for individuals with mobility impairments, including those with neurological conditions or musculoskeletal issues. During the test, the participant is timed while walking the 10-meter distance, with the time recorded starting when the participant's foot crosses the starting line and stopping when they cross the finish line. A shorter completion time indicates better walking speed and mobility, while longer times may suggest difficulties in gait or increased risk of falls. The 10MWT is a straightforward and effective tool used in clinical settings to evaluate functional mobility and track changes over time.

    First day

Secondary Outcomes (5)

  • Selective Control Assessment of the Lower Extremities (SCALE)

    First day

  • Trunk Control Measurement Scale (TCMS)

    First day

  • Pediatric Balance Scale (PBS)

    First day

  • Functional Independence Measure for Children (WeeFIM)

    First day

  • Modified Ashworth Scale (MAS)

    First day

Study Arms (1)

Children With Cerebral Palsy

Other: Assessment

Interventions

3 meter backward walk test (3MBWT), 10 meter walk test (10MWT), Selective Control Assessment of the Lower Extremities (SCALE), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Functional Independence Measure for Children (WeeFIM), Modified Ashworth Scale (MAS)

Children With Cerebral Palsy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children who apply for rehabilitation in Special Education and Rehabilitation Centers affiliated to the Ministry of National Education in the city of Antalya will be included in the study.

You may qualify if:

  • To be diagnosed with cerebral palsy by a specialist physician
  • Gross Motor Function Classification System (GMFCS) level I or II
  • Children with lower extremity muscles level ≤ 2 according to the Modified Ashworth Scale (MAS)
  • Ability to follow verbal commands
  • Modified Ashworth Scale (MAS) Level ≤2
  • Complete passive range of motion in the ankle and knee joints
  • Agree to participate in the study (with parent and child consent)

You may not qualify if:

  • Having had Botox (Botulinum toxin) or a surgical operation in the last 6 months
  • Having contractures in the ankle and knee joints that affect walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University

Antalya, Alanya, 07425, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Ebru Keklikci, Res. Assist.

    Alanya Alaaddin Keykubat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

July 17, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations