Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy

NCT04529343 | Completed

• 1 other identifier: 2018/1442
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy (CP) refers to a group of permanent disorders that occur in the brain of the fetus or infant, which are non-progressive, cause movement and posture disorder along with activity limitation. The upper extremity is frequently affected in patients with CP. The prevalence of upper extremity involvement has been reported between 60-83% in different studies. Virtual reality applications have been increasing recently in the field of neurological rehabilitation. In this study, researchers aimed to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation in patients with hemiplegic cerebral palsy.

Conditions

Cerebral Palsy; Upper Extremity Paresis

Keywords

virtual reality; rehabilitation; gamification

Outcome Measures

Primary Outcomes (1)

• Assisting Hand Assessment (AHA)

  AHA is a test that measures how patients with impaired upper extremity functions, such as hemiplegic CP or congenital brachial plexus injury, use the affected hand together with the healthy hand when playing with both hands. The AHA 5.0 version consists of 20 items that evaluate hand functions, and the raw score range is between 20 and 80 points. Higher scores indicate better hand function.

  12 weeks

Secondary Outcomes (6)

• Joint Range of Motion Measurement

  12 weeks

• Modified Ashworth Scale

  12 weeks

• Tardieu Scale

  12 weeks

• ABILHAND-Kids

  12 weeks

• QUEST

  12 weeks

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

To the virtual reality group; In addition to upper extremity exercises applied 2 days a week, upper extremity rehabilitation via virtual reality glasses will be performed 3 days a week for 6 weeks and each session will be 45 minutes.

Other: Virtual reality mediated upper extremity rehabilitation; Other: Classical exercise therapy for upper extremities

Control Group

ACTIVE COMPARATOR

Upper extremity exercises will be applied to the participants in the control group 2 days a week for 6 weeks.

Other: Classical exercise therapy for upper extremities

Interventions

Virtual reality mediated upper extremity rehabilitation OTHER

Game-based exercise will be applied for different range of motion of the upper extremity. Gamified exercise program consisting of 4 different scenarios will be applied 3 days a week for 6 weeks to the patients in the virtual reality group. A session takes an average of 45 minutes. Games to be applied; 1. Finger flexion-extension (10 minutes / session) 2. Wrist flexion, extension, ulnar and radial deviation (10 minutes / session) 3. Forearm pronation and supination (10 minutes / session) 4. Elbow flexion-extension-shoulder internal and external rotation (15 minutes / session) will have scenarios controlled with. All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes.

Virtual Reality Group

Classical exercise therapy for upper extremities OTHER

All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes.

Control Group; Virtual Reality Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having been diagnosed with hemiplegic CP by a specialist pediatric neurologist,
• Being between the ages of 5-12,
• Following the child's simple commands and participating in the given tasks,
• Being at the Gross Motor Function Classification System (KMFSS) Stage 1, 2 or 3,
• Being in Hand Skills Classification System (MACS) Stage 1, 2 or 3,
• Mild / moderate muscle tone; Modified Ashworth Scale level 1-2 and Tardieu Scale level 1-2,
• Parents agree to participate in the intensive treatment program and to cease all other upper extremity therapeutic interventions during the 3-month follow-up period.

You may not qualify if:

• Having uncontrollable epileptic seizures
• Significant contractures in the fingers, wrists, elbows and shoulders that prevent daily activities,
• Having serious vision and hearing problems,
• Cognitive impairments that prevent understanding and performing simple commands and tasks,
• Not being able to continue the treatment protocol due to the school program,
• Current or previous treatments that are not compatible with the treatment protocol of the study,
• Orthopedic surgery (tendon transfer / tendon lengthening) applied to the upper extremity,
• Receiving upper extremity treatment within the last 6 months (BTX-A or orthopedic interventions),
• Uncontrolled disease (endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal), active systemic inflammatory disease and / or history of malignancy

Sponsors & Collaborators

• Istanbul University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

Location

Related Publications (7)

• Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.

  PMID: 28109566 RESULT

• Cho C, Hwang W, Hwang S, Chung Y. Treadmill Training with Virtual Reality Improves Gait, Balance, and Muscle Strength in Children with Cerebral Palsy. Tohoku J Exp Med. 2016 Mar;238(3):213-8. doi: 10.1620/tjem.238.213.

  PMID: 26947315 RESULT

• Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.

  PMID: 29088476 RESULT

• Ren Z, Wu J. The Effect of Virtual Reality Games on the Gross Motor Skills of Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 14;16(20):3885. doi: 10.3390/ijerph16203885.

  PMID: 31614990 RESULT

• Hung YC, Gordon AM. Virtual reality training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Apr;60(4):334-335. doi: 10.1111/dmcn.13699. Epub 2018 Feb 14. No abstract available.

  PMID: 29442357 RESULT

• Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Vision-based serious games and virtual reality systems for motor rehabilitation: A review geared toward a research methodology. Int J Med Inform. 2019 Nov;131:103909. doi: 10.1016/j.ijmedinf.2019.06.016. Epub 2019 Jul 10.

  PMID: 31557701 RESULT

• Menekseoglu AK, Capan N, Arman S, Aydin AR. Effect of a Virtual Reality-Mediated Gamified Rehabilitation Program on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy: A Prospective, Randomized Controlled Study. Am J Phys Med Rehabil. 2023 Mar 1;102(3):198-205. doi: 10.1097/PHM.0000000000002060. Epub 2022 Jun 9.

  PMID: 35687751 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Paresis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe Resa Aydın, Prof. Dr.

  Istanbul University Istanbul Medicine Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assisting Hand Assessment was planned to be used in the evaluation of upper extremity functions as the primary outcome assessment tool. The person making this assessment will be blind to the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The virtual reality group will be given upper extremity rehabilitation via virtual reality glasses (3 days a week for 6 weeks and 45 minutes each session) and upper extremity exercises 2 days a week, while the control group will only be given upper extremity exercises 2 days a week.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 27, 2020
• Study Start: August 20, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)