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

NCT ID: NCT02841319

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Virtual reality exercises using Hand Tutor for 8 weeks

Group Type EXPERIMENTAL

Virtual Reality Exercises using Hand Tutor

Intervention Type 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.

Control

Home exercises for 8 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Sara Asghari Kaleibar

Sara ASGHARI KALEIBAR, MD Resident in the Department of Physical Medicine and Rehabilitation Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Resa Aydin, MD, Prof

Role: STUDY_DIRECTOR

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

Locations

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Istanbul Faculty of Medicine

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sara Asghari Kaleibar, MD

Role: CONTACT

00905380390939

Resa Aydin, MD, Prof

Role: CONTACT

00902124142000 ext. 12850

Facility Contacts

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Sara Asghari Kaleibar, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25855688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11132255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23458353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25610423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17370476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23948688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25015650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17370477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24051208 (View on PubMed)

Other Identifiers

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SKaleibar

Identifier Type: -

Identifier Source: org_study_id

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