Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Sara Asghari Kaleibar, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Virtual Reality Exercises using Hand Tutor Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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

  4. 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).

  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)


  6. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841319


Contacts
Layout table for location contacts
Contact: Sara Asghari Kaleibar, MD 00905380390939 saraasghari@yahoo.com
Contact: Resa Aydin, MD, Prof 00902124142000 ext 12850 resaaydin@gmail.com

Locations
Layout table for location information
Turkey
Istanbul Faculty of Medicine Recruiting
Istanbul, Turkey, 34093
Contact: Sara Asghari Kaleibar, MD         
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Study Director: Resa Aydin, MD, Prof Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
Publications:

Layout table for additonal information
Responsible Party: Sara Asghari Kaleibar, Sara ASGHARI KALEIBAR, MD Resident in the Department of Physical Medicine and Rehabilitation Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey, Istanbul University
ClinicalTrials.gov Identifier: NCT02841319    
Other Study ID Numbers: SKaleibar
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no permission to share individual participant data.
Keywords provided by Sara Asghari Kaleibar, Istanbul University:
Virtual reality
Hemiplegic
Cerebral Palsy
upper extremity
hand function
Additional relevant MeSH terms:
Layout table for MeSH terms
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases