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

Primary Purpose

Cerebral Palsy, Upper Extremity Problem

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Robot-assisted upper extremity rehabilitation
Conventional rehabilitation
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Robotic rehabilitation, Upper extremity

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Ankara Bilkent City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic rehabilitation group

Conventional rehabilitation group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 13, 2023
Last Updated
September 26, 2023
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05883488
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Upper Extremity Problem
Keywords
Cerebral Palsy, Robotic rehabilitation, Upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic rehabilitation group
Arm Type
Experimental
Arm 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.
Arm Title
Conventional rehabilitation group
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
Intervention Type
Other
Intervention Name(s)
Robot-assisted upper extremity rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
Primary Outcome Measure Information:
Title
QUEST (Quality of Upper Extremity Skills Test)
Description
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.
Time Frame
Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months
Secondary Outcome Measure Information:
Title
ABILHAND-Kids
Description
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.
Time Frame
Change from baseline ABILHAND-Kids at 4 weeks and 3 months
Title
Box and Block Test
Description
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.
Time Frame
Change from baseline Box and Block Test at 4 weeks and 3 months
Title
KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)
Description
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.
Time Frame
Change from baseline KINDL at 4 weeks and 3 months
Title
Modified Ashworth Scala (MAS)
Description
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.
Time Frame
Change from baseline Modified Ashworth Scala at 4 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Banuçiçek Türk
Phone
0536 299 02 38
Email
banuciceku@gmail.com
Facility Information:
Facility Name
Ankara Bilkent City Hospital
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banuçiçek Türk, Doctor
Phone
+905362990238
Email
banuciceku@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24724587
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.
Results Reference
background
PubMed Identifier
23080043
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.
Results Reference
background

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

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