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Completed

NCT Number: NCT04263701

Dual Task Training in Spastic Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KMSU

Kütahya, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

therapeutic exercises

Other

Conventional physiotherapy exercises for children with cerebral palsy

Dual task training

Other

Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy

Primary outcomes

  1. Gate speed of time-distance gait parameters

    Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week

    Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.

  2. Step length of time-distance gait parameters

    Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week

    Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.

  3. Stride length of time-distance gait parameters

    Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week

    Stride length will be evaluated using with gait platform.The software gives the outcome as cm.

  4. Step time of time-distance gait parameters

    Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week

    Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.

  5. Stride time of time-distance gait parameters

    Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week

    Step time will be evaluated using with gait platform.The software gives the outcome as sec.

  6. Cadance of time-distance gait parameters

    Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week

    Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.

  7. Visual gait analysis

    Time frame: Change from baseline visual gait analysis at 8th week and 16th week

    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.

  8. Center of Pressure path length of balance parameters

    Time frame: Change from baseline balance parameters at 8th week and 16th week.

    Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.

  9. Ellipse area of balance parameters

    Time frame: Change from baseline balance parameters at 8th week and 16th week.

    Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.

  10. Functional balance

    Time frame: Change from baseline functional balance at 8th week and 16th week

    Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance.

Secondary outcomes

  1. Gross Motor Function Measurement

    Time frame: Change from baseline Gross Motor Function Measurement at 8th week and 16th week

    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.

  2. Muscle Tonus

    Time frame: Change from baseline Muscle Tonus at 8th week and 16th week

    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.

  3. Functional Mobility Skills

    Time frame: Change from baseline Functional Mobility Skills at 8th week and 16th week

    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.

  4. Functional Independence Levels

    Time frame: Change from baseline Functional Independence Levels at 8th week and 16th week

    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.

  5. Health-related quality of life

    Time frame: Change from baseline health-related quality of life at 8th week and 16th week

    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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2020
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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