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Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Upper Extremity Paresis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality mediated upper extremity rehabilitation
Classical exercise therapy for upper extremities
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring virtual reality, rehabilitation, gamification

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Ahmet Kıvanç Menekşeoğlu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Joint Range of Motion Measurement
Goniometric measurements of upper extremity range of motion will be done actively and passively.
Modified Ashworth Scale
Evaluation of upper extremity spasticity will be done with a modified Ashworth scale.The modified ashworth scale is scored between 0 and 4, with higher scores indicating severe spasticity.
Tardieu Scale
Evaluation of upper extremity spasticity will be done with a Tardieu scale. The Tardieu scale is scored between 0 and 5, with higher scores indicating severe spasticity.
ABILHAND-Kids
ABILHAND-Kids is a functional scale that is used to measure hand ability in patients, guiding the treatment planning of CP and similar childhood neurological diseases, determining targets. ABILHAND-Kids evaluates the hand functions of patients with 21 items, and each item is scored between 0-2 points. Higher scores indicate better hand function. (Minimum: 0, Maximum: 42 points)
QUEST
Upper extremity motion quality and hand skills of patients with CP were evaluated by QUEST. This test consists of 5 parts. In the test, each item is scored between 0 and 2, depending on whether it can perform the action or not. It has subtitles including independent movements, grasping, weight bearing, protective extension, hand function degree, spasticity rating and cooperation rating. Higher scores indicate better upper limb function. (Minimum: 0, Maximum: 100 points)
KINDL
KINDL is a questionnaire prepared in 1994 to evaluate the quality of life in the pediatric population and adolescents. There are various forms of the questionnaire for children of different age groups and families. The items in this test are scored between 1-5 points. Higher scores indicate better upper limb function. (Minimum: 0, Maximum: 100 points)

Full Information

First Posted
August 18, 2020
Last Updated
March 16, 2023
Sponsor
Istanbul University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT04529343
Brief Title
Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy
Official Title
Evaluation of the Effectiveness of Virtual Reality-Based Upper Extremity Rehabilitation in Patients With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cerebral Palsy (CP) is a group of permanent disorders of movement and posture development due to non-progressive damage to the developing fetal or infant brain, causing activity limitation. Motor disorders in CP are mostly accompanied by sensory and perceptual problems, cognitive disorders, communicative and perceptual problems, epilepsy and secondary musculoskeletal problems. CP is one of the most common causes of disability in childhood. Brain damage that causes CP can occur in the prenatal, perinatal or postnatal period. Accompanying epilepsy, cognitive disorders, learning impairment, communication problems, perception limitation, behavioral problems, visual disturbances, hearing disorders, oral motor function problems, dysphagia, constipation, gastroesophageal reflux disease, dental problems, urinary symptoms, osteoporosis can be seen in patients with CP. Technologies that are developing in rehabilitation are increasingly being used. Among these technologies, the use of virtual reality by trained physiatrists and physiotherapists provides an environment where children with cerebral palsy can exercise. In addition to intense exercise, simultaneous visual and auditory feedback can be received. Virtual reality can also provide a comparison between the degree of movement children perform in the real world and the degree of movements they observe in the virtual environment. All these features make virtual reality a potentially viable tool for improving the motor skills of children with CP. Virtual reality-based rehabilitation is an emerging treatment modality for the motor rehabilitation of children with cerebral palsy. Neuroplasticity studies have shown that neurological development is positively associated with active participation and motivation during virtual reality-based rehabilitation intervention. In addition to motivation, virtual therapy also improves neural reorganization that optimizes rehabilitation outcomes in children with cerebral palsy. The virtual scenario seems to encourage motor learning, the retention of learned skills, and the transfer of skills to real-world situations. In many studies, improvement in posture, balance, upper extremity functions, joint control and walking has been detected with virtual therapy. Increased 'biofeedbacks' in neuromotor rehabilitation allowed therapists to methodologically design and control their intervention strategies. 40 patients with a diagnosis of Cerebral Palsy who applied to the Pediatric Rehabilitation Unit of Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, who meet the inclusion criteria will be included in this randomized, controlled, single blind and prospectively planned study. At the beginning of the study, 40 hemiplegic CP patients who meet the inclusion criteria will be randomized into two groups according to the random order created by the computer program after being numbered according to the order of application to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Pediatric Rehabilitation Unit. Upper extremity rehabilitation (bimanually 3 days a week for 6 weeks and 45 minutes per session) and physiotherapy (TG: Treatment Group) will be given to the first group accompanied by virtual reality, and only physiotherapy (CG: Control Group) will be given to the second group. When the power analysis was performed to calculate the number of patients and when the results obtained from other studies were taken into account, it was concluded that at least 18 patients should be included in each group to obtain 0.95 power at 95% confidence interval. Considering that few people will be excluded from the study during the study, it was found appropriate to include 20 patients in each group and to start the study with a total of 40 people. Before starting the study, the patients will be informed about the study and their consent will be obtained and demographic characteristics such as age, height and weight will be evaluated. Participants and their parents will be informed in writing and verbally about the purpose, duration and method of application of the research, and the "Informed Consent Form" will be signed after their consent is obtained. The study is planned to be carried out in a single center in the Department of Physical Medicine and Rehabilitation of Istanbul University Istanbul Medical Faculty. The virtual reality technology to be used in the study has temporary side effects such as nausea, vomiting, and dizziness, and side effects to increase epileptic seizures. For this reason, patients with uncontrolled epileptic seizures were excluded from the study. If effects such as nausea, vomiting and dizziness develop during the intervention, the session will be terminated and symptomatic treatment will be given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Upper Extremity Paresis
Keywords
virtual reality, rehabilitation, gamification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Upper extremity exercises will be applied to the participants in the control group 2 days a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Virtual reality mediated upper extremity rehabilitation
Intervention Description
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; Finger flexion-extension (10 minutes / session) Wrist flexion, extension, ulnar and radial deviation (10 minutes / session) Forearm pronation and supination (10 minutes / session) 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.
Intervention Type
Other
Intervention Name(s)
Classical exercise therapy for upper extremities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assisting Hand Assessment (AHA)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Joint Range of Motion Measurement
Description
Goniometric measurements of upper extremity range of motion will be done actively and passively.
Time Frame
12 weeks
Title
Modified Ashworth Scale
Description
Evaluation of upper extremity spasticity will be done with a modified Ashworth scale.The modified ashworth scale is scored between 0 and 4, with higher scores indicating severe spasticity.
Time Frame
12 weeks
Title
Tardieu Scale
Description
Evaluation of upper extremity spasticity will be done with a Tardieu scale. The Tardieu scale is scored between 0 and 5, with higher scores indicating severe spasticity.
Time Frame
12 weeks
Title
ABILHAND-Kids
Description
ABILHAND-Kids is a functional scale that is used to measure hand ability in patients, guiding the treatment planning of CP and similar childhood neurological diseases, determining targets. ABILHAND-Kids evaluates the hand functions of patients with 21 items, and each item is scored between 0-2 points. Higher scores indicate better hand function. (Minimum: 0, Maximum: 42 points)
Time Frame
12 weeks
Title
QUEST
Description
Upper extremity motion quality and hand skills of patients with CP were evaluated by QUEST. This test consists of 5 parts. In the test, each item is scored between 0 and 2, depending on whether it can perform the action or not. It has subtitles including independent movements, grasping, weight bearing, protective extension, hand function degree, spasticity rating and cooperation rating. Higher scores indicate better upper limb function. (Minimum: 0, Maximum: 100 points)
Time Frame
12 weeks
Title
KINDL
Description
KINDL is a questionnaire prepared in 1994 to evaluate the quality of life in the pediatric population and adolescents. There are various forms of the questionnaire for children of different age groups and families. The items in this test are scored between 1-5 points. Higher scores indicate better upper limb function. (Minimum: 0, Maximum: 100 points)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Resa Aydın, Prof. Dr.
Organizational Affiliation
Istanbul University Istanbul Medicine Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmet Kıvanç Menekşeoğlu
City
Istanbul
ZIP/Postal Code
34015
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
28109566
Citation
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.
Results Reference
result
PubMed Identifier
26947315
Citation
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.
Results Reference
result
PubMed Identifier
29088476
Citation
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.
Results Reference
result
PubMed Identifier
31614990
Citation
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.
Results Reference
result
PubMed Identifier
29442357
Citation
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.
Results Reference
result
PubMed Identifier
31557701
Citation
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.
Results Reference
result

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Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy

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