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

NCT02841319 | Unknown

• 1 other identifier: SKaleibar
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assisting Hand Assessment (AHA)

  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.

  Within 7 Days

Secondary Outcomes (6)

• Hand Grip Measurement

  Within 7 Days

• ABILHAND

  Within 7 Days

• Range of Motion (ROM)

  Within 7 Days

• Modified Ashworth Scale (MAS)

  Within 7 Days

• TARDIEU SCALE

  Within 7 Days

Study Arms (2)

Intervention

EXPERIMENTAL

Virtual reality exercises using Hand Tutor for 8 weeks

Other: Virtual Reality Exercises using Hand Tutor

Control

NO INTERVENTION

Home exercises for 8 weeks

Interventions

Virtual Reality Exercises using Hand Tutor OTHER

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.

Intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• Gabis LV, Tsubary NM, Leon O, Ashkenasi A, Shefer S. Assessment of Abilities and Comorbidities in Children With Cerebral Palsy. J Child Neurol. 2015 Oct;30(12):1640-5. doi: 10.1177/0883073815576792. Epub 2015 Apr 8.

  PMID: 25855688 BACKGROUND

• Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.

  PMID: 11132255 BACKGROUND

• Green D, Schertz M, Gordon AM, Moore A, Schejter Margalit T, Farquharson Y, Ben Bashat D, Weinstein M, Lin JP, Fattal-Valevski A. A multi-site study of functional outcomes following a themed approach to hand-arm bimanual intensive therapy for children with hemiplegia. Dev Med Child Neurol. 2013 Jun;55(6):527-33. doi: 10.1111/dmcn.12113. Epub 2013 Mar 5.

  PMID: 23458353 BACKGROUND

• Basu AP, Pearse J, Kelly S, Wisher V, Kisler J. Early intervention to improve hand function in hemiplegic cerebral palsy. Front Neurol. 2015 Jan 6;5:281. doi: 10.3389/fneur.2014.00281. eCollection 2014.

  PMID: 25610423 BACKGROUND

• Morris C. Definition and classification of cerebral palsy: a historical perspective. Dev Med Child Neurol Suppl. 2007 Feb;109:3-7. doi: 10.1111/j.1469-8749.2007.tb12609.x.

  PMID: 17370476 BACKGROUND

• Meyer-Heim A, van Hedel HJ. Robot-assisted and computer-enhanced therapies for children with cerebral palsy: current state and clinical implementation. Semin Pediatr Neurol. 2013 Jun;20(2):139-45. doi: 10.1016/j.spen.2013.06.006.

  PMID: 23948688 BACKGROUND

• Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, Detrembleur C, Lejeune TM, Stoquart G. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb;29(2):183-92. doi: 10.1177/1545968314541172. Epub 2014 Jul 11.

  PMID: 25015650 BACKGROUND

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

• Schiariti V, Klassen AF, Cieza A, Sauve K, O'Donnell M, Armstrong R, Masse LC. Comparing contents of outcome measures in cerebral palsy using the International Classification of Functioning (ICF-CY): a systematic review. Eur J Paediatr Neurol. 2014 Jan;18(1):1-12. doi: 10.1016/j.ejpn.2013.08.001. Epub 2013 Sep 17.

  PMID: 24051208 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Resa Aydin, MD, Prof

  Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Central Study Contacts

Sara Asghari Kaleibar, MD

CONTACT

00905380390939; saraasghari@yahoo.com

Resa Aydin, MD, Prof

CONTACT

00902124142000; resaaydin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sara ASGHARI KALEIBAR, MD Resident in the Department of Physical Medicine and Rehabilitation Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey

Study Record Dates

• First Submitted: May 21, 2016
• First Posted: July 22, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)