Dual Task Training in Spastic Cerebral Palsy

Study Overview
=================
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.

Official Title
-----------------
Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Therapeutic exercises
* Other: Dual Task Training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Self-controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Physiotherapy Group<br>45 minutes, 2 days in a week for 8 weeks | Other: Therapeutic exercises<br>* Conventional physiotherapy exercises for children with cerebral palsy<br>|
| Experimental: Dual Task Training Group<br>45 minutes, 2 days in a week for 8 weeks | Other: Dual Task Training<br>* Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gate speed of time-distance gait parameters | Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h. | Change from baseline time-distance gait parameters at 8th week and 16th week | 
| Step length of time-distance gait parameters | Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity. | Change from baseline time-distance gait parameters at 8th week and 16th week | 
| Stride length of time-distance gait parameters | Stride length will be evaluated using with gait platform.The software gives the outcome as cm. | Change from baseline time-distance gait parameters at 8th week and 16th week | 
| Step time of time-distance gait parameters | Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity. | Change from baseline time-distance gait parameters at 8th week and 16th week | 
| Stride time of time-distance gait parameters | Step time will be evaluated using with gait platform.The software gives the outcome as sec. | Change from baseline time-distance gait parameters at 8th week and 16th week | 
| Cadance of time-distance gait parameters | Step time will be evaluated using with gait platform.The software gives the outcome as steps/min. | Change from baseline time-distance gait parameters at 8th week and 16th week | 
| Visual gait analysis | Visual gait analysis will be performed with Edinburgh Visual Gait Score. Edinburg Visual Gait Score is scoring between 0 to 34 for each lower extremity. The higher scores points above 0 means abnormal gate. | Change from baseline visual gait analysis at 8th week and 16th week | 
| Center of Pressure path length of balance parameters | Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm. | Change from baseline balance parameters at 8th week and 16th week. | 
| Ellipse area of balance parameters | Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2. | Change from baseline balance parameters at 8th week and 16th week. | 
| Functional balance | Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance. | Change from baseline functional balance at 8th week and 16th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measurement | Gross motor function measurement will be evaluate using with Gross Motor Function Measurement-88. The instrument consist of 5 dimensions which names are A- Lying and rolling, B- Sitting, C- Crawling and Kneeling, D- Standing and E- Walking-running-jumping. Each dimension is scoring 0-100. The higher scores indicate better motor function. | Change from baseline Gross Motor Function Measurement at 8th week and 16th week | 
| Muscle Tonus | Muscle tonus will be evaluate using with Modified Ashworth Scale. This assesment will be performed by a physiotherapist. The Physiotherapist evaluate the muscle tonus of upper and lower extremity muscules. Scoring is between 0-4 and higher scores indicate hypertonus. | Change from baseline Muscle Tonus at 8th week and 16th week | 
| Functional Mobility Skills | Functional mobility skills will be evaluate using with 1-Minute Walk Test. The test perform on a 20 meters platform. The patient walk on the platform as quick as in 1 munite. The walking distance is recorded. | Change from baseline Functional Mobility Skills at 8th week and 16th week | 
| Functional Independence Levels | Functional independence levels will be evaluate using with Functional Independence Measurement (WeeFIM). WeeFIM is consist of 6 part, 18 items. It consists of self-care, sphincter control, locomotion, transfers, communication and social cognition subtitles. Scoring is between 18 to 126 and the higher scores indicate better functional indepence levels. | Change from baseline Functional Independence Levels at 8th week and 16th week | 
| Health-related quality of life | Health-related quality of life will be evaluate using with Pediatric Quality of Life Inventory TM. The inventory include daily activities, school activities, movement and balance, pain and hurt, fatique, eating activities and speech and communication subtitles. Each subtitles is scoring 0 to 100 and the higher scores indicate lower problems. | Change from baseline health-related quality of life at 8th week and 16th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, dual task training, gait, balance