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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883488
• Other study ID #: AnkaraCHBilkent-BT
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: May 2023
• Source: Ankara City Hospital Bilkent
• Contact: Banuçiçek Türk
• Phone: 0536 299 02 38
• Email: banuciceku[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Upper Extremity Problem

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QUEST (Quality of Upper Extremity Skills Test)	It is a test developed to measure upper extremity functions. It consists of 7 sub-headings including dissociated movements, grasping, weight bearing, protective extension, hand function rating, spasticity rating and cooperativeness rating.	Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months
Secondary	ABILHAND-Kids	It is a functional scale developed to measure manual abilities. It measures the child's manual ability during daily activities and parents are asked to evaluate during these activities. The test consists of 21 questions and parents answer the questions in the test as impossible, difficult or easy. It is scored as impossible: 0, difficult: 1, easy: 2. The maximum score in the test is 42 and the minimum score is 0. Higher scores indicate better manual ability.	Change from baseline ABILHAND-Kids at 4 weeks and 3 months
Secondary	Box and Block Test	It is a time-based test that evaluates rough manual dexterity. The participant is asked to throw the cubes on one side of a wooden box divided into two into the other compartment, and the result is obtained by counting how many cubes he has thrown in 60 seconds.	Change from baseline Box and Block Test at 4 weeks and 3 months
Secondary	KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)	It is a questionnaire that measures the quality of life in children and adolescents, and there are child and family forms for different age groups. In this study, KINDL 3-6 age family form and 7-17 age family form will be used. KINDL 3-6 age family form is a questionnaire consisting of 52 questions in total about physical well-being, emotional well-being, self-esteem, family, social relations, kindergarten/nursery, other questions and illness. KINDL 7-17 age family form is a questionnaire consisting of 30 questions in total about physical well-being, emotional well-being, self-esteem, family, social relations, school, and illness. Parents answer questions as never, rarely, sometimes, often, or always. Questions are scored from 1 to 5. Negative questions are scored by reversing. Each section is scored between 0-100. A higher score indicates a higher quality of life.	Change from baseline KINDL at 4 weeks and 3 months
Secondary	Modified Ashworth Scala (MAS)	It is used to evaluate the severity of spasticity. The joint is moved passively throughout the range of motion and the felt resistance is evaluated. In this study, shoulder adductors, elbow flexors, wrist flexors, and finger flexors will be evaluated with MAS. Spasticity severity is evaluated in 4 degrees. (0: no increase in muscle tone, 4: affected parts are rigid in flexion and extension). Higher scores indicate greater spasticity severity.	Change from baseline Modified Ashworth Scala at 4 weeks and 3 months