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Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Therapy
Conventional Physiotherapy
Activity Training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral Palsy, Upper Extremity Rehabilitation, Virtual Reality, Technology-Assisted Therapy,, Active Video Game

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed as spastic hemiparetic cerebral palsy by a physician,
  • must be level I, II, and III according to the Gross Motor Function Classification System (GMFCS)
  • must be level I, II, and III according to the Manuel Ability Classification System (MACS)

Exclusion Criteria:

  • have cardiac or orthopedic contraindications for sitting, standing, and walking
  • have orthopedic surgery to upper extremity and trunk in the last 6 months
  • have used of spasticity-reducing medication or botulinum toxin injections to upper extremity or trunk in the last 6 months
  • being severely mentally affected
  • have any neurological conditions accompanying cerebral palsy (seizures, visual deficits, etc.)

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Group

Activity Training (Control) Group

Arm Description

The first group was received conventional physiotherapy and virtual reality therapy for 60 minutes. The conventional physiotherapy interventions, including joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles and special for the needs of the child, was applied to both groups. The virtual reality group received that simulate daily life and contain individual scenarios by using the USE-IT system for thirty minutes. USE-IT (Most Rehabilitation, Ankara, Turkey) is a 2D non-immersive virtual reality system that plays games on a 50-inches touchscreen. The children played "the matching, plumber, plumber, math, and car wash games" in accordance with their reaching map results. The treatment were given three times a week for eight weeks.

The second group was received conventional physiotherapy and, activity training which the same movement patterns with virtual reality games for 60 minutes. The children in the activity training group received unilateral, bilateral, and bimanual activity training that supported manual skills for thirty minutes. Similar activity patterns were presented to the virtual reality group and activity training (control) group. The treatment were given three times a week for eight weeks.

Outcomes

Primary Outcome Measures

Change from Baseline "The Quality of Upper Extremity Skills Test Scores" at 8 weeks.
The Quality of Upper Extremity Skills Test was used to assess the function and quality of upper limb movements. This test has a total of 7 subdivisions, and the scoring of each section is calculated using a standardized formula. Each chapter is scored between 0-100 within itself. The first four section scores are used to calculate the total score. A high score indicates better the quality of the movement. The participant evaluated by a physiotherapist at baseline and after 8 weeks treatment.

Secondary Outcome Measures

Change from Baseline "The Modified Ashworth Scale Scores" at 8 weeks.
The Modified Ashworth Scale was used to assess the severity of spasticity of shoulder internal rotators, elbow, wrist, and finger flexors and elbow pronators, thumb abductors. The score is between 0-5 for each muscle. As the score increases, the severity of spasticity increases.
Change from Baseline "The Reaching Map Test Scores" at 8 weeks.
Forty balloons, randomized, appears on the screen, and the system asked the child to exploded the balloons. The child was positioned in front of the screen, and hip-knee angles were positioned 90° flexion. Through the special algorithm in the system, the "individual" access area was determined, and the scenario of the games was automatically adjusted accordingly. The areas that the child can reach on the screen were divided into five difficulty levels. Five levels from easy to very difficult describe as yellow, green, blue, navy blue and red areas were automatically calculated by the USE-IT system.

Full Information

First Posted
November 7, 2020
Last Updated
November 13, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04630678
Brief Title
Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy
Official Title
Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy: an Evaluator Blinded, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to investigate the effect of individualized virtual reality therapy on upper extremity functions of children with hemiparetic cerebral palsy. Forty children (26 boys, 14 girls) with spastic hemiparetic cerebral palsy were included in this study. The primary outcome measure of this study was the Quality of Upper Extremity Skill Test, secondary outcome measures were the Modified Ashworth Scale and the "Reaching Map Test". The children were randomized into two groups. The first group was received conventional physiotherapy and virtual reality therapy for 60 minutes.The second group was received conventional physiotherapy and, activity training which the same movement patterns with virtual reality games for 60 minutes. Both treatments were given three times a week for eight weeks.
Detailed Description
Participants Forty children (20 boys, 20 girls) were included in the study, and their demographic information was recorded. The participants were divided, using "randomizer.org" with a simple randomization method, into two different groups: the Virtual Reality or Activity Training (control) groups. Study Design All children were assessed at baseline and after eight weeks of treatment. The children in both groups were evaluated by the same physiotherapist who was blinded. The treatment was given by a different physiotherapist who has been working in the field of pediatric physiotherapy for ten years Interventions The participants were randomized into two groups. The first group was received conventional physiotherapy and virtual reality therapy for 60 minutes. The second group was received conventional physiotherapy and, activity training which the same movement patterns with virtual reality games for 60 minutes. Both treatments were given three times a week for eight weeks. The conventional physiotherapy interventions, including joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles and special for the needs of the child, was applied to both groups. The virtual reality therapy group received that simulate daily life and contain individual scenarios by using the USE-IT system for thirty minutes. USE-IT (Most Rehabilitation, Ankara, Turkey) is a 2D non-immersive virtual reality system that plays games on a 50-inches touchscreen. The children played "the matching, plumber, plumber, math, and car wash games" in accordance with their reaching map results. As the system detects not only hand but also object touch the real-life materials (cloths and hoses etc.) were used to stimulate grip and sense during games. The children in the activity training group received unilateral, bilateral, and bimanual activity training that supported manual skills for thirty minutes. Similar activity patterns were presented to the virtual reality group and activity training group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral Palsy, Upper Extremity Rehabilitation, Virtual Reality, Technology-Assisted Therapy,, Active Video Game

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The children were randomized into two groups.The first group was received virtual reality therapy. The second group was received activity training. Both treatments were given three times a week for eight weeks.
Masking
Outcomes Assessor
Masking Description
The children in both groups were evaluated by the same physiotherapist who was blinded. The treatment was given by a different physiotherapist who has been working in the field of pediatric physiotherapy for ten years.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
The first group was received conventional physiotherapy and virtual reality therapy for 60 minutes. The conventional physiotherapy interventions, including joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles and special for the needs of the child, was applied to both groups. The virtual reality group received that simulate daily life and contain individual scenarios by using the USE-IT system for thirty minutes. USE-IT (Most Rehabilitation, Ankara, Turkey) is a 2D non-immersive virtual reality system that plays games on a 50-inches touchscreen. The children played "the matching, plumber, plumber, math, and car wash games" in accordance with their reaching map results. The treatment were given three times a week for eight weeks.
Arm Title
Activity Training (Control) Group
Arm Type
Active Comparator
Arm Description
The second group was received conventional physiotherapy and, activity training which the same movement patterns with virtual reality games for 60 minutes. The children in the activity training group received unilateral, bilateral, and bimanual activity training that supported manual skills for thirty minutes. Similar activity patterns were presented to the virtual reality group and activity training (control) group. The treatment were given three times a week for eight weeks.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Therapy
Intervention Description
Virtual reality games were applied to participants for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
Joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles were applied to participants for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Activity Training
Intervention Description
Unilateral, bilateral, and bimanual activity training that supported manual skills for 30 minutes.
Primary Outcome Measure Information:
Title
Change from Baseline "The Quality of Upper Extremity Skills Test Scores" at 8 weeks.
Description
The Quality of Upper Extremity Skills Test was used to assess the function and quality of upper limb movements. This test has a total of 7 subdivisions, and the scoring of each section is calculated using a standardized formula. Each chapter is scored between 0-100 within itself. The first four section scores are used to calculate the total score. A high score indicates better the quality of the movement. The participant evaluated by a physiotherapist at baseline and after 8 weeks treatment.
Time Frame
At baseline and after 8 weeks treatment.
Secondary Outcome Measure Information:
Title
Change from Baseline "The Modified Ashworth Scale Scores" at 8 weeks.
Description
The Modified Ashworth Scale was used to assess the severity of spasticity of shoulder internal rotators, elbow, wrist, and finger flexors and elbow pronators, thumb abductors. The score is between 0-5 for each muscle. As the score increases, the severity of spasticity increases.
Time Frame
At baseline and after 8 weeks treatment.
Title
Change from Baseline "The Reaching Map Test Scores" at 8 weeks.
Description
Forty balloons, randomized, appears on the screen, and the system asked the child to exploded the balloons. The child was positioned in front of the screen, and hip-knee angles were positioned 90° flexion. Through the special algorithm in the system, the "individual" access area was determined, and the scenario of the games was automatically adjusted accordingly. The areas that the child can reach on the screen were divided into five difficulty levels. Five levels from easy to very difficult describe as yellow, green, blue, navy blue and red areas were automatically calculated by the USE-IT system.
Time Frame
At baseline and after 8 weeks treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed as spastic hemiparetic cerebral palsy by a physician, must be level I, II, and III according to the Gross Motor Function Classification System (GMFCS) must be level I, II, and III according to the Manuel Ability Classification System (MACS) Exclusion Criteria: have cardiac or orthopedic contraindications for sitting, standing, and walking have orthopedic surgery to upper extremity and trunk in the last 6 months have used of spasticity-reducing medication or botulinum toxin injections to upper extremity or trunk in the last 6 months being severely mentally affected have any neurological conditions accompanying cerebral palsy (seizures, visual deficits, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mert Doğan, mSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy

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