Clinical trial NCT05883488: Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
Official title: Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Upper Extremity Problem
Keywords: Cerebral Palsy
Robotic rehabilitation
Upper extremity
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of robotic rehabilitation, a treatment method for improving the motor functions of the upper extremities, is gradually increasing in children with cerebral palsy.

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.

Detailed description: In this study, it was planned to include 42 patients diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy, aged 5-15 years, who were treated in the Pediatric Rehabilitation Service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and met the inclusion criteria.

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.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy
* 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:

* Injection of antispasticity drugs (eg Botox) into upper extremity muscles and/or upper extremity orthopedic surgery in the last 6 months
* 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

Primary outcomes:
measure: QUEST (Quality of Upper Extremity Skills Test)
timeFrame: Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months
Secondary outcomes:
measure: ABILHAND-Kids
timeFrame: Change from baseline ABILHAND-Kids at 4 weeks and 3 months
measure: Box and Block Test
timeFrame: Change from baseline Box and Block Test at 4 weeks and 3 months
measure: KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)
timeFrame: Change from baseline KINDL at 4 weeks and 3 months
measure: Modified Ashworth Scala (MAS)
timeFrame: Change from baseline Modified Ashworth Scala at 4 weeks and 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
References:
citation: 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.
citation: 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.