Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy

NCT05999617 | Completed

• 1 other identifier: CPdualtask
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (6)

• Pediatric Balance Scale (PBS)

  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.

  Change from Baseline PBS at 12 weeks

• Timed Up and Go Test (TUG)

  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.

  Change from Baseline TUG at 12 weeks

• One Leg Standing Test (OLST)

  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.

  Change from Baseline OLST at 12 weeks

• 3-Meter Backward Walk Test (3MBWT)

  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.

  Change from Baseline 3MBWT at 12 weeks

• 6 Meter Walk Test (6MWT)

  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.

  Change from Baseline 6MWT at 12 weeks

• The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)

  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.

  Change from Baseline KINDL at 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Other: Rehabilitation

Interventions

Rehabilitation OTHER

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Fethiye Special Son Atilim Special Education and Rehabilitation Center

Muğla, Fethiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• İsmail Uysal, PhD

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

• Fatih Özden, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• İsmet Tümtürk, MSc

  Süleyman Demirel University

  PRINCIPAL INVESTIGATOR

• Ahmet İmerci, MD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: May 12, 2023
• Primary Completion: August 21, 2023
• Study Completion: August 31, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)