Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy

Ankara City Hospital

Status: Enrolling

Conditions: Upper Extremity Problem; Cerebral Palsy

Treatments: Other: Robot-assisted upper extremity rehabilitation; Other: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05883488

AnkaraCHBilkent-BT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Robotic rehabilitation group

Experimental group

Description:

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.

Treatment:

Other: Robot-assisted upper extremity rehabilitation

Other: Conventional rehabilitation

Conventional rehabilitation group

Active Comparator group

Description:

Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.

Treatment:

Other: Conventional rehabilitation