NCT04777773

Brief Summary

There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. In all these studies, it is clearly seen that children with CP have more dual-task complexities than their typically developing peers. Some of these studies draw attention to dual-task education in children with CP. However, other than a randomized controlled study and a case report in the literature, we did not find any studies investigating the effectiveness of dual-task training in children with CP. When the literature is examined in detail, there is no study that examines the effect of dual-task exercise programs on walking activities and children's participation in daily life in children with CP. This study has been planned based on this deficiency in the literature. Based on ICF, This study has been planned dual-task training for children with CP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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

June 27, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

February 26, 2021

Last Update Submit

March 1, 2021

Conditions

Cerebral PalsyDiplegiaHemiplegic Cerebral PalsyPhysical DisabilityParticipation, PatientActivity, Motor

Keywords

cerebral palsydual-task trainingactivityparticipation

Outcome Measures

Primary Outcomes (7)

  • 10m walking test

    10m walking test (the speed of gait is measured)

    5 min

  • 10m walking test with dual-task

    10m walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)

    5 min

  • 10m backward walking test

    10m backward walking test (the speed of gait is measured)

    5 min

  • 10m backward walking test with dual-task

    10m backward walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)

    5 min

  • balance

    Balance skills of participators are assessed with 'Pediatric Berg Balance' .

    15 min

  • participation of daily life

    Participation of daily life of children are assessed with PODCI questionnaire.

    15 min

  • Visual Gait Assessment

    Participators' positions of joints are assessed with Edinburg Visual Score. Children walked 10m walking pathway. The camera records were frontside, backward, and laterals.

    10 min

Study Arms (2)

control group

OTHER

classical physical therapy+ classical physical therapy

Other: dual-task training

study group

OTHER

classical physical therapy+ dual-task training

Other: dual-task training

Interventions

dual-task trainingOTHER

dual-task training

control groupstudy group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being diagnosed with cerebral palsy,
  • Having spastic type unilateral and bilateral involvement,
  • Being between the ages of 7-18,
  • Being GMFCSS Level I and Level II,
  • Continuing normal education (not being a mainstreaming student),
  • Not having any surgical operation involving the musculoskeletal system in the last 6 months,
  • Not having Botulinum Toxin application in the last 6 months.

You may not qualify if:

  • Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
  • Being a behavioral problem that makes it difficult to participate in the study,
  • Inability to walk without support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu Uni

Ordu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyPatient ParticipationMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 2, 2021

Study Start

June 27, 2019

Primary Completion

February 27, 2020

Study Completion

February 27, 2020

Last Updated

March 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)