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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02841319
Enrollment
34
Registered
2016-07-22
Start date
2016-05-31
Completion date
2016-12-31
Last updated
2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Virtual reality, Hemiplegic, Cerebral Palsy, upper extremity, hand function

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.

Interventions

OTHERVirtual Reality Exercises using Hand Tutor

Virtual reality technology is rapidly becoming a popular application for physical rehabilitation and motor control research. The prototype, which includes a built-in movement sensor, allows the user to do controlled exercises as part of a rehabilitation program. 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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assisting Hand Assessment (AHA)Within 7 DaysAHA measures are valid and reliable for children aged between 18 months and 12 years with the diagnosis of unilateral cerebral palsy. It measures how effectively children with unilateral hand dysfunction use their involved hand in collaboration with their uninvolved hand to perform bimanual tasks.The test is administered in two steps. First, a video-recorded play session lasting 10 to 15 minutes is conducted with specific toys from the AHA test kit.Second, the scoring is performed by a review of the video on 22 items by certificated professional. The AHA version 4.4 includes 22 test items each rated on a 4-point scale, with a total raw score range between 22-88 points. The higher score indicating higher ability.

Secondary

MeasureTime frameDescription
ABILHANDWithin 7 DaysABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs. 21 manual activities perceived by the children parents. Each item is answered on a 3-level scale (impossible, difficult, easy). The Parent is asked to fill in the questionnaire by estimating their child's performance independent of the limb the child actually. The online analysis converts the raw scores into a linear measure of manual ability. ABILHAND-Kids has been validated in cerebral palsy children (age 6-15).
Range of Motion (ROM)Within 7 DaysBy using the Universal Goniometer, the active and passive ROM will be assessed based on the 360-degrees system in radioulnar pronation and supination, wrist flexion and extension, 2nd to 5th metacarpophalangeal joints
Hand Grip MeasurementWithin 7 DaysGrip strength will measured with BASELINE Dynamometer. The participants will seat and the shoulder is hold in the adducted and minimally internal rotated, elbow flexed at 90 degrees, forearm in natural position and wrist flexed between 0 and 30 degrees (Kg/f).
TARDIEU SCALEWithin 7 DaysTardieu Scale (TS): It assesses the response of the muscle to passive movement of limb in both slow and fast speeds, on the other word it evaluated velocity dependent muscle tonicity. Intensity of muscle reaction (Y) is included six-point scale (0-5)
Pulp Pinch Strength MeasurementWithin 7 DaysPulp pinch strength is measured by the JAMAR Hydraulic Pinch Gauge which evaluates the pinch strength between first and second digits. The participants will seat and the shoulder is hold in the adducted and minimally internal rotated, elbow flexed at 90 degrees, forearm in natural position and wrist flexed between 0 and 30 degrees (Kg/f).
Modified Ashworth Scale (MAS)Within 7 DaysOne of the methods for measuring muscle spasticity includes manually moving a limb through its ROM to passively stretch specific muscle groups. Modified Ashworth Scale for Grading Spasticity is six-point scale (0-5).

Countries

Turkey (Türkiye)

Contacts

Primary ContactSara Asghari Kaleibar, MD
saraasghari@yahoo.com00905380390939
Backup ContactResa Aydin, MD, Prof
resaaydin@gmail.com00902124142000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026