NCT06170814

Brief Summary

This study was planned to examine the effects of different focuses (external and internal focus)of attention on functional walking and balance in children with cerebral palsy. Individuals with CP between the ages of 6-18 will be included in the research. It was planned to include 24 individuals in total, 12 individuals in each group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 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

First Submitted

Initial submission to the registry

December 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

December 4, 2023

Last Update Submit

December 30, 2024

Conditions

Keywords

cerebral palsyExternal focusinternal focusgait and balance

Outcome Measures

Primary Outcomes (1)

  • Gait

    Walking function will be evaluated twice with the C-Mill Walking Training System, before and at the end of treatment (6 weeks of treatment).

    6 week

Secondary Outcomes (4)

  • balance

    6 week

  • Trunk control measurement scale

    6 week

  • Pediatric Functional Independence Scale

    6 week

  • pediatric berg balance scale

    6 week

Study Arms (2)

external odak

Exercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs and tracks will be built to improve walking and balance functions. During exercises, attention is directed to movement and an environmental stimulus in the external focus of attention.

Other: Exercise

internal focus

Exercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs, and tracks will be built to improve walking and balance functions. In internal focus during exercises, attention is directed directly to body movements.

Other: Exercise

Interventions

Exercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs and tracks will be built to improve walking and balance functions. One group will be given external focus stimuli, the other group will be given internal focus stimuli.

external odakinternal focus

Eligibility Criteria

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

Children with hemiparatic cerebral palsy between the ages of 6 and 18 will be included in the study. In order to perceive the commands during the exercise, the children participating in the study must have a level of cognitive development to be cooperative.

You may qualify if:

  • Being diagnosed with spastic type cerebral palsy between the ages of 6-18
  • Volunteerism of the family and individuals to participate in the study
  • Being at levels I and II according to the Gross Motor Classification System
  • Having the cognitive development to be cooperative

You may not qualify if:

  • Having undergone any orthopedic and/or neurological surgery in the last 6 months,
  • Having hearing and/or vision loss that would prevent participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabia ERASLAN

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Beauchet O, Berrut G. [Gait and dual-task: definition, interest, and perspectives in the elderly]. Psychol Neuropsychiatr Vieil. 2006 Sep;4(3):215-25. French.

  • Yamada M, Raisbeck LD, Porter JM. The Effects of Using Imagery to Elicit an External Focus of Attention. Res Q Exerc Sport. 2021 Sep;92(3):559-565. doi: 10.1080/02701367.2020.1733455. Epub 2020 Mar 6.

  • Bunger A, Urfer-Maurer N, Grob A. Multimethod Assessment of Attention, Executive Functions, and Motor Skills in Children With and Without ADHD: Children's Performance and Parents' Perceptions. J Atten Disord. 2021 Feb;25(4):596-606. doi: 10.1177/1087054718824985. Epub 2019 Jan 30.

  • Blank R, Barnett AL, Cairney J, Green D, Kirby A, Polatajko H, Rosenblum S, Smits-Engelsman B, Sugden D, Wilson P, Vincon S. International clinical practice recommendations on the definition, diagnosis, assessment, intervention, and psychosocial aspects of developmental coordination disorder. Dev Med Child Neurol. 2019 Mar;61(3):242-285. doi: 10.1111/dmcn.14132. Epub 2019 Jan 22.

  • Zorlular R, Akinci M, Elbasan B. Effects of focus of attention on gait parameters and balance performance in children with unilateral cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2026 Feb;48(3):829-841. doi: 10.1080/09638288.2025.2548412. Epub 2025 Aug 21.

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 14, 2023

Study Start

December 30, 2023

Primary Completion

August 15, 2024

Study Completion

September 15, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations