Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05999617
Collaborator
(none)
30
1
2
3.6
8.2

Study Details

Study Description

Brief Summary

Cerebral palsy (CP) is the most common neurological disorder in children and one of the major causes of motor disability. CP causes changes in postural and sensory integration, balance, coordination disorders and muscle weakness due to problems in muscle tone. An effective rehabilitation program is of great importance in solving many problems that can be associated with decreased balance control. Researchers have stated that rehabilitation programs with repetitive special tasks are effective. The aim of the study was to compare the effects of conventional physiotherapy and dual task exercise training in addition to conventional physiotherapy on balance, mobility, physical performance and quality of life in children with cerebral palsy.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Dual Task Exercise Training on Balance, Mobility, Physical Performance and Quality of Life in Children With Cerebral Palsy
Actual Study Start Date :
May 12, 2023
Anticipated Primary Completion Date :
Aug 21, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Conventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.

Other: Rehabilitation
Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.

Active Comparator: Control Group

Conventional rehabilitation program (stretching, strengthening, balance) will be employed.

Other: Rehabilitation
Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.

Outcome Measures

Primary Outcome Measures

  1. Pediatric Balance Scale (PBS) [Change from Baseline PBS at 12 weeks]

    The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.

  2. Timed Up and Go Test (TUG) [Change from Baseline TUG at 12 weeks]

    Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.

  3. One Leg Standing Test (OLST) [Change from Baseline OLST at 12 weeks]

    Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.

  4. 3-Meter Backward Walk Test (3MBWT) [Change from Baseline 3MBWT at 12 weeks]

    A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.

  5. 6 Meter Walk Test (6MWT) [Change from Baseline 6MWT at 12 weeks]

    A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command "Start". The stopwatch is stopped by touching the finish line.

  6. The Generic Children's Health-Related Quality of Life Questionnaire (KINDL) [Change from Baseline KINDL at 12 weeks]

    The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Hemiplegic, monoplegic, unilaterally affected or diplegic children aged 5-12 years with cerebral palsy

  • Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions) or 2 (walks with restrictions)

  • Understand simple commands

  • Signing the consent form

Exclusion Criteria:
  • Children and their families who do not want to be involved in the study

  • Children with vision and hearing problems

  • hildren with secondary orthopedic problems and children with walking aids

  • Circumstances that would prevent carrying out assessments and exercise training or communicating

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fethiye Special Son Atilim Special Education and Rehabilitation Center Muğla Fethiye Turkey

Sponsors and Collaborators

  • Muğla Sıtkı Koçman University

Investigators

  • Study Director: İsmail Uysal, PhD, Muğla Sıtkı Koçman University
  • Principal Investigator: Fatih Özden, PhD, Muğla Sıtkı Koçman University
  • Principal Investigator: İsmet Tümtürk, MSc, Süleyman Demirel University
  • Principal Investigator: Ahmet İmerci, MD, Muğla Sıtkı Koçman University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatih Ozden, Assistant Professor, Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier:
NCT05999617
Other Study ID Numbers:
  • CPdualtask
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023