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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06170814
Other study ID # Cerebral palsy and gait
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 30, 2023
Est. completion date September 15, 2024

Study information

Verified date May 2024
Source Gazi University
Contact Rabia ERASLAN
Phone +905424362082
Email rabiaeraslan118@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

In the external focus of attention (EF), attention is directed to movement and an environmental stimulus. In the internal focus (IF), attention is directed directly to body movements. In revealing positive effects in external focus; Methods such as metaphor, analogy, imaginary objects, mental analogies can be used. Adopting an External focus of attention (focusing on the effects of movements on the object or environment), as opposed to an Internal focus of attention (focusing on body movements), has been found to significantly improve performance on a variety of tasks. Walking and balance are essential for activities of daily living and social participation; Therefore, it is often considered one of the most important activities in daily life. Walking and balance is an automatic rhythmic motor behavior controlled mostly by subcortical brain regions. Automaticity means that walking can be performed without requiring attention. Although it seems like a very simple activity, it is actually a very complex chain of movements in which the brain, spinal cord, muscles, bones and joints work together in coordination. However, movement, balance and gait disorders cause individuals with CP to spend more energy, deteriorate their mobility and decrease their independence. Although the beneficial effects of EF have not yet been demonstrated for every population, the constrained action hypothesis encourages the use of an EF for teaching motor skills. Looking at the literature, the effects of EF on the development of motor performance in children with cerebral palsy have not been examined. Therefore, this study aims to examine the effects of external focus of attention on gait and balance. Individuals with CP between the ages of 6-18 will be included in the research. After the purpose and scope of the study are explained to all individuals and their families who agree to participate in the study, their families will be asked to read and sign the volunteering form. All individuals who meet the inclusion criteria will be randomly divided into 2 groups (external focus and internal focus). It was planned to include 24 individuals in total, 12 individuals in each group. The same evaluations will be made to all individuals participating in the study by a physiotherapist who is an expert in the field. In addition to conventional physiotherapy for 6 weeks, individuals will be included in an exercise program that focuses on external and internal attention for 30 minutes a day, 3 days a week. Evaluation of walking function will be done with the C-Mill Walking Training System. Balance function will be performed by standing on one leg, pediatric berg balance scale and functional reaching tests.Independence Pediatric Functional Independence Scale will be evaluated with.Trunk control, trunk control measurement scale will be evaluated with.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date September 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Exercise
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.

Locations

Country Name City State
Turkey Rabia ERASLAN Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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 o — View Citation

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: 10.1177/108705471 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 balance Balance function will be evaluated twice, before and at the end of treatment (6 weeks of treatment), with the one-leg standing test and the functional reaching test. 6 week
Secondary Trunk control measurement scale trunk control, trunk control measurement scale will be evaluated with. 6 week
Secondary Pediatric Functional Independence Scale Independence, Pediatric Functional Independence Scale will be evaluated with. 6 week
Secondary pediatric berg balance scale The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. 6 week
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