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CompletedNCT04630678Updated Nov 16, 2020

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

An interventional study of Virtual Reality Therapy and Conventional Physiotherapy in Cerebral Palsy, Spastic, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-11-16.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Aug 2017, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy, Spastic

Keywords

  • Cerebral Palsy
  • Upper Extremity Rehabilitation
  • Virtual Reality
  • Technology-Assisted Therapy,
  • Active Video Game
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 40 is above the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Virtual Reality Group

    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

  • Active comparator
    Activity Training (Control) Group

    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

  • OtherVirtual Reality Therapy

    Virtual reality games were applied to participants for 30 minutes.

  • OtherConventional Physiotherapy

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

  • OtherActivity Training

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

06

What researchers measure

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.

    Time frame: At baseline and after 8 weeks treatment.

Secondary outcomes

  1. 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.

    Time frame: At baseline and after 8 weeks treatment.

  2. 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.

    Time frame: At baseline and after 8 weeks treatment.

07

Study locations

1 site
  • Hacettepe University
    Ankara, 06100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04630678
Lead sponsor
Hacettepe University
Responsible party
Mert Doğan (Master of Science, Hacettepe University) — Principal investigator
First posted
Nov 16, 2020
Start date
Aug 1, 2017
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Nov 16, 2020

Study contacts

Mert Doğan, mSc
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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