Clinical trial NCT04263701: Dual Task Training in Spastic Cerebral Palsy
Official title: Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
dual task training
gait
balance
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self-controlled study
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.

Detailed description: In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27 and above from the Modified Mini Mental Test were included.

Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8 weeks, and in addition to the routine physiotherapy program dual task training program 45 minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the routine physiotherapy program and after the dual task training program. Children will be evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform, Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with spastic diplegic cerebral palsy,
* Being at level 1 or 2 according to the Gross Motor Function Classification System,
* Being at level 1 according to Communication Function Classification System,
* To adapt to the evaluations,
* To get 27 points or above from the Modified Mini Mental Test (MMMT).

Exclusion Criteria:

* Having had injuries such as strains, sprains or fractures of the lower extremity in the last six months,
* Having undergone a surgical intervention or Botulinum toxin in the last six months,
* Having any known chronic systemic problems,
* Having uncontrollable seizures,
* Having vision or hearing problems.

Primary outcomes:
measure: Gate speed of time-distance gait parameters
timeFrame: Change from baseline time-distance gait parameters at 8th week and 16th week
measure: Step length of time-distance gait parameters
timeFrame: Change from baseline time-distance gait parameters at 8th week and 16th week
measure: Stride length of time-distance gait parameters
timeFrame: Change from baseline time-distance gait parameters at 8th week and 16th week
measure: Step time of time-distance gait parameters
timeFrame: Change from baseline time-distance gait parameters at 8th week and 16th week
measure: Stride time of time-distance gait parameters
timeFrame: Change from baseline time-distance gait parameters at 8th week and 16th week
measure: Cadance of time-distance gait parameters
timeFrame: Change from baseline time-distance gait parameters at 8th week and 16th week
measure: Visual gait analysis
timeFrame: Change from baseline visual gait analysis at 8th week and 16th week
measure: Center of Pressure path length of balance parameters
timeFrame: Change from baseline balance parameters at 8th week and 16th week.
measure: Ellipse area of balance parameters
timeFrame: Change from baseline balance parameters at 8th week and 16th week.
measure: Functional balance
timeFrame: Change from baseline functional balance at 8th week and 16th week
Secondary outcomes:
measure: Gross Motor Function Measurement
timeFrame: Change from baseline Gross Motor Function Measurement at 8th week and 16th week
measure: Muscle Tonus
timeFrame: Change from baseline Muscle Tonus at 8th week and 16th week
measure: Functional Mobility Skills
timeFrame: Change from baseline Functional Mobility Skills at 8th week and 16th week
measure: Functional Independence Levels
timeFrame: Change from baseline Functional Independence Levels at 8th week and 16th week
measure: Health-related quality of life
timeFrame: Change from baseline health-related quality of life at 8th week and 16th week
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: KMSU
Study officials:
affiliation: KMSU
name: Eda Ozge Okur, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Okur EO, Arik MI, Okur I, Gokpinar HH, Gunel MK. Dual-task training effect on gait parameters in children with spastic diplegic cerebral palsy: Preliminary results of a self-controlled study. Gait Posture. 2022 May;94:45-50. doi: 10.1016/j.gaitpost.2022.02.020. Epub 2022 Feb 17.