The Hand Functions In Cerebral Palsy

March 12, 2024 updated by: Cetin Sayaca, Uludag University

Which One is The Most Effective On The Hand Functions In Cerebral Palsy: Constraint-Induced Movement Therapy or Constraint-Induced Movement Therapy With Virtual Reality? A Randomized Controlled Trial.

The hand motor functions are very important in the daily life activities, educational, and social participation of children. Losing The hand motor functions limit these activities and participation. Constraint-induced movement therapy (CIMT) or virtual reality (VR) therapy has often been preferred to improve the hand's motor functions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CIMT and VR are used to improve the motor functions of the hand in cerebral palsy (CP). The aim of this study was to compare the effects of CIMT-VR use and only CIMT use on hand functions in children with hemiparetic cerebral palsy. Hand function and performance were evaluated with the Jebsen-Taylor and Moberg pick-up tests. All evaluations were made twice; before the first therapy and after six weeks. Children with hemiparetic CP were divided into three groups randomly (Traditional techniques (TT), TT+CIMT, and TT+CIMT+VR).

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Uskudar Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

The inclusion criteria of the study were determined to be

  • aged 8 to 18 years,
  • diagnosed with hemiparetic CP,
  • being level 2 or 3 according to the gross motor function measurement scale and the manual ability classification system.

The exclusion criteria of the study were,

  • severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping),
  • having pharmacologic medicine for spasticity,
  • having botulinum toxin A injections in the last 6 months,
  • having upper extremity surgery,
  • having visual and/or auditory problems which affect therapy or evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional techniques
TT was planned according to the child's hand that was needed. Neurodevelopmental facilitation techniques (Bobath therapy), stretching, and grasping types (cylindrical, spherical, hook, key, fingertip, lateral) were used in hands therapy for 45 minutes two days in a week for all children who were accepted to participate in this study.
Other: TT
TT: Traditional Techniques
Experimental: traditional therapy with constraint induced movement therapy
The sling was put on the child's non-paretic arm to apply CIMT. The around of the sling was sewn except the elbow and secured snugly to the trunk with a waist strap to prevent assisting the affected hand during the application of CIMT. However, children with CP who were in the this group used the sling for three hours in daily activity, playing, etc. at home. The CIMT was given as a home program and monitorization was done by the follow-up form every week with no therapy during the weekend.
Other: TT+CIMT
TT: Traditional Techniques CIMT: constraint-induced movement therapy
Experimental: traditional therapy with constraint induced movement therapy and virtual reality
After the TT session, a child with CP used the sling for 45 minutes at the rehabilitation center with VR therapy. VR therapy with CIMT was used in hands therapy for 45 minutes at two days a week after TT. During the VR therapy, the child was encouraged verbally to play X-box.The X-box Kinect 360 (by the Microsoft corporation) was used for VR therapy. It has a kinetic sensor that perceives the movement of the child with CP. The child's movement can be seen through the monitor in real time. VR does not need special buttons to play. Therefore, a child with CP who had impaired fine motor skills and dexterity can play easily.
Other: TT+CIMT+VR
TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Jebsen-Taylor Test
Time Frame: this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
The Jebsen-Taylor Test is a reliable tool that evaluates the hand function of children with CP. The test includes seven items. These items are; writing a 24-letter sentence, turning over five cards, picking up small objects (two pieces of pennies/bottle caps/paperclips), simulated feeding (using a teaspoon and five kidney beans), stacking four checkers, picking up and moving five large empty tin boxes and then five large full boxes. During the assessment, the child with CP was seated in front of a table and test was performed by hemiparetic hand. Time was recorded on each item by stopwatch. The total score was calculated by collecting all items' time.
this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
Moberg pick-up test
Time Frame: this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
To evaluate the functional performance of the hemiparetic hand Moberg pick-up test (MPUT) was used. MPUT consists of twelve items which are a wing nut, screw, key, nail, ₺1 coin, 50 kurus coin, washer, safety pin, paper clip, large and medium-sized hexagonal nut, and small square nut. The plastic container (60x30 cm) was placed lengthwise about 15 cm from the edge of the table on the opposite side of the items. The child was seated in a chair. The hemiparetic hand of children with CP was put on the same side as the 12 items which were randomly placed on the table. Children with CP were ordered to pick up the items one at a time and place them into the plastic container as fast as possible. The time was recorded with a stopwatch.
this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Study Chair: Esin KADIKOYLU, Pt, Uskudar University
  • Study Chair: Eren DEMIRAYAK, Pt, Uskudar University
  • Principal Investigator: Cetin Sayaca, Assoc. Prof., Uludag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Actual)

March 10, 2024

Study Completion (Actual)

March 12, 2024

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIMT vs VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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