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

NCT ID: NCT05883488

Last Updated: 2023-09-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-19

Study Completion Date

2023-11-15

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Upper Extremity Problem

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Robot-assisted upper extremity rehabilitation

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

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.

Intervention Type OTHER

Conventional rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Banuçiçek Türk

Role: CONTACT

0536 299 02 38

Facility Contacts

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Banuçiçek Türk, Doctor

Role: primary

+905362990238

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.

Reference Type BACKGROUND
PMID: 24724587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23080043 (View on PubMed)

Other Identifiers

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AnkaraCHBilkent-BT

Identifier Type: -

Identifier Source: org_study_id

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