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

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic
• Interventions: Other: Virtual Reality Therapy; Other: Conventional Physiotherapy; Other: Activity Training

• Registration Number: NCT04630678
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-07
• Study First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Study First Posted: 2020-11-16
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Group	Conventional Physiotherapy	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.
Virtual Reality Group	Virtual Reality Therapy	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.
Activity Training (Control) Group	Activity Training	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.
Activity Training (Control) Group	Conventional Physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline "The Quality of Upper Extremity Skills Test Scores" at 8 weeks.	At baseline and after 8 weeks treatment.	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

Name	Time	Method
Change from Baseline "The Modified Ashworth Scale Scores" at 8 weeks.	At baseline and after 8 weeks treatment.	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.	At baseline and after 8 weeks treatment.	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey