Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Effectiveness of Dual Task Exercise Training on Balance, Mobility, Physical Performance and Quality of Life in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999617
• Other study ID #: CPdualtask
• Status: Completed
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Fethiye Special Son Atilim Special Education and Rehabilitation Center	Mugla	Fethiye

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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