Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
NCT ID: NCT05883488
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2023-07-19
2023-11-15
Brief Summary
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The aim of this study is to investigate the effect of robot-assisted rehabilitation for the upper extremity on upper extremity functions, manual skills and quality of life in patients with unilateral or bilateral/triplegic spastic cerebral palsy and also to compare the effect of robot-assisted upper extremity rehabilitation compared to traditional rehabilitation methods.
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Detailed Description
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Participants will be divided into two groups as study and control groups. In addition to the conventional rehabilitation program, the study group will be included in the robot-assisted upper extremity rehabilitation program, while the control group will be included in the conventional rehabilitation program only.
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment. Assessments will be made before initiating treatment, at the end of treatment, and 3 months after initiation of treatment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic rehabilitation group
The robotic rehabilitation group will receive a robot-assisted upper extremity rehabilitation program in addition to the conventional rehabilitation program.The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes.
Robot-assisted upper extremity rehabilitation
The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment.
Conventional rehabilitation
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
Conventional rehabilitation group
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
Conventional rehabilitation
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
Interventions
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Robot-assisted upper extremity rehabilitation
The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment.
Conventional rehabilitation
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
Eligibility Criteria
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Inclusion Criteria
* Be between the ages of 5-15
* Levels I, II and III according to the Manual Ability Classification System (MACS)
* Have sufficient cognitive level, such as the ability to understand and follow simple instructions, and to perform desired tasks
* The upper extremity dimensions are suitable for the robot
* Parents and patients aged ≥ 9 years have agreed to participate in the study
Exclusion Criteria
* Having musculoskeletal disorders and peripheral nervous system disorders that impair the ability to use the upper extremity robotic system
* Having severe muscle spasticity and/or contracture
* Having uncontrolled seizures and/or presence of visually induced seizures
* Having severe learning difficulties, behavioral problems, skin lesions, visual and/or hearing difficulties that may affect function and participation
5 Years
15 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Locations
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Ankara Bilkent City Hospital
Ankara, Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Chen YP, Howard AM. Effects of robotic therapy on upper-extremity function in children with cerebral palsy: A systematic review. Dev Neurorehabil. 2016;19(1):64-71. doi: 10.3109/17518423.2014.899648. Epub 2014 Apr 11.
Fasoli SE, Ladenheim B, Mast J, Krebs HI. New horizons for robot-assisted therapy in pediatrics. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S280-9. doi: 10.1097/PHM.0b013e31826bcff4.
Other Identifiers
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AnkaraCHBilkent-BT
Identifier Type: -
Identifier Source: org_study_id
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