NCT04529343|Completed
Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy
Evaluation of the Effectiveness of Virtual Reality-Based Upper Extremity Rehabilitation in Patients With Cerebral Palsy
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Evaluation of the Effectiveness of Virtual Reality-Based Upper Extremity Rehabilitation in Patients With Cerebral Palsy
Sponsor study identifier
interventional
40
1 country
1
Study Start
August 20, 2020
Actual (reported)Primary Completion
December 30, 2020
Actual (reported)Study Completion
December 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2020
Actual (reported)August 20, 2020
Actual (reported)August 27, 2020
Actual (reported)December 30, 2020
Actual (reported)December 30, 2020
Actual (reported)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
Joint Range of Motion Measurement
12 weeks
Modified Ashworth Scale
12 weeks
Tardieu Scale
12 weeks
ABILHAND-Kids
12 weeks
QUEST
12 weeks
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.
Upper extremity exercises will be applied to the participants in the control group 2 days a week for 6 weeks.
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.
Ahmet Kıvanç Menekşeoğlu
Istanbul, 34015, Turkey (Türkiye)
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.
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.
Ayşe Resa Aydın, Prof. Dr.
Istanbul University Istanbul Medicine Faculty
40 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2020
First Posted
Prognosis of Functionality in Cerebral Palsy: A Retrospektif Study
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
August 27, 2020
Study Start
August 20, 2020
Actual (reported)Primary Completion
December 30, 2020
Actual (reported)Study Completion
December 30, 2020
Actual (reported)Last Updated
March 20, 2023
Record last verified: 2023-03
The patient data kept in the study will be shared with other researchers in case of a possible scientific publication. Personal data of the patients will not be shared, data of primary and secondary outcome criteria will be shared.
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Source: ClinicalTrials.gov.
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