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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Exercises using Hand Tutor
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Virtual reality, Hemiplegic, Cerebral Palsy, upper extremity, hand function

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Virtual reality exercises using Hand Tutor for 8 weeks

Home exercises for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hand Grip Measurement
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
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)
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)
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
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
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).

Full Information

First Posted
May 21, 2016
Last Updated
July 25, 2016
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02841319
Brief Title
The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Virtual reality, Hemiplegic, Cerebral Palsy, upper extremity, hand function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Virtual reality exercises using Hand Tutor for 8 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Home exercises for 8 weeks
Intervention Type
Other
Intervention Name(s)
Virtual Reality Exercises using Hand Tutor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assisting Hand Assessment (AHA)
Description
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.
Time Frame
Within 7 Days
Secondary Outcome Measure Information:
Title
Hand Grip Measurement
Description
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).
Time Frame
Within 7 Days
Title
ABILHAND
Description
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).
Time Frame
Within 7 Days
Title
Range of Motion (ROM)
Description
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
Time Frame
Within 7 Days
Title
Modified Ashworth Scale (MAS)
Description
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).
Time Frame
Within 7 Days
Title
TARDIEU SCALE
Description
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)
Time Frame
Within 7 Days
Title
Pulp Pinch Strength Measurement
Description
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).
Time Frame
Within 7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Asghari Kaleibar, MD
Phone
00905380390939
Email
saraasghari@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Resa Aydin, MD, Prof
Phone
00902124142000
Ext
12850
Email
resaaydin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Resa Aydin, MD, Prof
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Asghari Kaleibar, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have no permission to share individual participant data.
Citations:
PubMed Identifier
25855688
Citation
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.
Results Reference
background
PubMed Identifier
11132255
Citation
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.
Results Reference
background
PubMed Identifier
23458353
Citation
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. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316.
Results Reference
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PubMed Identifier
25610423
Citation
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.
Results Reference
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PubMed Identifier
17370476
Citation
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.
Results Reference
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PubMed Identifier
23948688
Citation
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.
Results Reference
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PubMed Identifier
25015650
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
Results Reference
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Citation
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.
Results Reference
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The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy

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