Dual Task Training in Spastic Cerebral Palsy

NCT04263701 | Completed

• 1 other identifier: KMSU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; dual task training; gait; balance

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Gross Motor Function Measurement

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

• Muscle Tonus

  Change from baseline Muscle Tonus at 8th week and 16th week

• Functional Mobility Skills

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

• Functional Independence Levels

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

• Health-related quality of life

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

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

45 minutes, 2 days in a week for 8 weeks

Other: Therapeutic exercises

Dual Task Training Group

EXPERIMENTAL

45 minutes, 2 days in a week for 8 weeks

Other: Dual Task Training

Interventions

Therapeutic exercises OTHER

Conventional physiotherapy exercises for children with cerebral palsy

Conventional Physiotherapy Group

Dual Task Training OTHER

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

Dual Task Training Group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

KMSU

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35247824 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Eda Ozge Okur, Msc

  KMSU

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Self-controlled study

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 11, 2020
• Study Start: July 1, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)