NCT05883488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

September 28, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

March 13, 2023

Last Update Submit

September 26, 2023

Conditions

Cerebral PalsyUpper Extremity Problem

Keywords

Cerebral PalsyRobotic rehabilitationUpper extremity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • ABILHAND-Kids

    Change from baseline ABILHAND-Kids at 4 weeks and 3 months

  • Box and Block Test

    Change from baseline Box and Block Test at 4 weeks and 3 months

  • KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)

    Change from baseline KINDL at 4 weeks and 3 months

  • Modified Ashworth Scala (MAS)

    Change from baseline Modified Ashworth Scala at 4 weeks and 3 months

Study Arms (2)

Robotic rehabilitation group

EXPERIMENTAL

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.

Other: Robot-assisted upper extremity rehabilitationOther: Conventional rehabilitation

Conventional rehabilitation group

ACTIVE COMPARATOR

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

Other: Conventional rehabilitation

Interventions

Robot-assisted upper extremity rehabilitationOTHER

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.

Robotic rehabilitation group
Conventional rehabilitationOTHER

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

Conventional rehabilitation groupRobotic rehabilitation group

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 24724587BACKGROUND

  • 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.

    PMID: 23080043BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Banuçiçek Türk

CONTACT

0536 299 02 38banuciceku@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

June 1, 2023

Study Start

July 19, 2023

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

September 28, 2023

Record last verified: 2023-05

Locations

TU(1)