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The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy

I

Istanbul University

Status

Unknown

Conditions

Cerebral Palsy

Treatments

Other: Virtual Reality Exercises using Hand Tutor

Study type

Interventional

Funder types

Other

Identifiers

NCT02841319
SKaleibar

Details and patient eligibility

About

The investigators have planned a research on the effects of virtual reality therapy and home exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul University Istanbul Faculty of Medicine in the Department of Physical Medicine and Rehabilitation. The eligible patients will be randomized into two groups. The patients in intervention group will participate in a computer based virtual reality exercise program for a period of 8 weeks supervised by the investigators. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.

Full description

The current study is a prospective, randomized controlled interventional trial, which will conduct in the Istanbul University Istanbul Faculty of Medicine in 2016. The study was approved by the Ethics Committee in conformity with the Declaration of Helsinki. Prior to data collection, all participants will provide informed consent. By the order of application to the outpatient clinics, the eligible participants will randomly allocated to two groups using the computer-generated random numbers: intervention group (n=17) and control group (n=17). Information on demographic characteristics (age, gender, body mass index, educational level), pre-natal history, parent educational level and past medical history will obtain at baseline assessment. After baseline assessment, the patients in intervention group will participate in a computer based virtual reality exercise program with HandTutor equipment. The supervised intervention program consists of a forty-minute exercise session three times a week for 8 weeks. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. The home exercise program consists of different games and exercises such as range of motion, stretch, and strengthening exercises for hand. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.

Enrollment

34 estimated patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children with hemiplegic cerebral palsy diagnosed by the specialist
  • Active wrist extension ≥ 20 °
  • Gross Motor Function Classification System score: 1-2
  • Manual Ability Classification System score: 1-3
  • The ability to follow simple commands and participate in the task

Exclusion criteria

  • Contracture in upper limb
  • Absence of vision and hearing problems
  • Uncontrolled seizure
  • Lack of movement in the hemiplegic upper limb
  • History of orthopedic surgery (tendon transfer / tendon lengthening) to the affected upper extremity
  • Any treatment for upper limb in the last 6 months including BTX-A or orthopedic interventions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups

Intervention
Experimental group
Description:
Virtual reality exercises using Hand Tutor for 8 weeks
Treatment:
Other: Virtual Reality Exercises using Hand Tutor
Control
No Intervention group
Description:
Home exercises for 8 weeks

Trial contacts and locations

1

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Central trial contact

Resa Aydin, MD, Prof; Sara Asghari Kaleibar, MD

Data sourced from clinicaltrials.gov

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