The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT02841319|
Recruitment Status : Unknown
Verified July 2016 by Sara Asghari Kaleibar, Istanbul University.
Recruitment status was: Recruiting
First Posted : July 22, 2016
Last Update Posted : July 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Other: Virtual Reality Exercises using Hand Tutor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||May 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Virtual reality exercises using Hand Tutor for 8 weeks
Other: Virtual 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.
No Intervention: Control
Home exercises for 8 weeks
- Assisting Hand Assessment (AHA) [ Time Frame: Within 7 Days ]AHA 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.
- Hand Grip Measurement [ Time Frame: Within 7 Days ]Grip 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).
- ABILHAND [ Time Frame: Within 7 Days ]ABILHAND-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) [ Time Frame: Within 7 Days ]By 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
- Modified Ashworth Scale (MAS) [ Time Frame: Within 7 Days ]One 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).
- TARDIEU SCALE [ Time Frame: Within 7 Days ]
Tardieu 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 Measurement [ Time Frame: Within 7 Days ]Pulp 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841319
|Contact: Sara Asghari Kaleibar, MDfirstname.lastname@example.org|
|Contact: Resa Aydin, MD, Prof||00902124142000 ext email@example.com|
|Istanbul Faculty of Medicine||Recruiting|
|Istanbul, Turkey, 34093|
|Contact: Sara Asghari Kaleibar, MD|
|Study Director:||Resa Aydin, MD, Prof||Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation|