Clinical trial NCT02841319: The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy
Official title: The Effects of Virtual Reality Therapy Compared With Home Exercise Program on Upper Extremity Functions in Children With Hemiplegic Cerebral Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Virtual reality
Hemiplegic
Cerebral Palsy
upper extremity
hand function
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: Within 7 Days
Secondary outcomes:
measure: Hand Grip Measurement
timeFrame: Within 7 Days
measure: ABILHAND
timeFrame: Within 7 Days
measure: Range of Motion (ROM)
timeFrame: Within 7 Days
measure: Modified Ashworth Scale (MAS)
timeFrame: Within 7 Days
measure: TARDIEU SCALE
timeFrame: Within 7 Days
measure: Pulp Pinch Strength Measurement
timeFrame: Within 7 Days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
name: Resa Aydin, MD, Prof
role: STUDY_DIRECTOR
References:
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