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

NCT04630678 | Completed

• 1 other identifier: 2017/08-23, KA-17050
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Upper Extremity Rehabilitation; Virtual Reality; Technology-Assisted Therapy,; Active Video Game

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and after 8 weeks treatment.

Secondary Outcomes (2)

• Change from Baseline "The Modified Ashworth Scale Scores" at 8 weeks.

  At baseline and after 8 weeks treatment.

• Change from Baseline "The Reaching Map Test Scores" at 8 weeks.

  At baseline and after 8 weeks treatment.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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.

Other: Virtual Reality Therapy; Other: Conventional Physiotherapy

Activity Training (Control) Group

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy; Other: Activity Training

Interventions

Virtual Reality Therapy OTHER

Virtual reality games were applied to participants for 30 minutes.

Virtual Reality Group

Conventional Physiotherapy OTHER

Joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles were applied to participants for 30 minutes.

Activity Training (Control) Group; Virtual Reality Group

Activity Training OTHER

Unilateral, bilateral, and bimanual activity training that supported manual skills for 30 minutes.

Activity Training (Control) Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mert Doğan, mSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 16, 2020
• Study Start: August 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)