Clinical trial NCT04630678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral Palsy
Upper Extremity Rehabilitation
Virtual Reality
Technology-Assisted Therapy,
Active Video Game
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Change from Baseline "The Quality of Upper Extremity Skills Test Scores" at 8 weeks.
timeFrame: At baseline and after 8 weeks treatment.
Secondary outcomes:
measure: Change from Baseline "The Modified Ashworth Scale Scores" at 8 weeks.
timeFrame: At baseline and after 8 weeks treatment.
measure: Change from Baseline "The Reaching Map Test Scores" at 8 weeks.
timeFrame: At baseline and after 8 weeks treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Mert Doğan, mSc
role: PRINCIPAL_INVESTIGATOR
References: