NCT05988944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

August 4, 2023

Last Update Submit

March 12, 2024

Conditions

Keywords

Hand FunctionsVirtual RealityConstraint-Induced Movement TherapyCerebral PalsyRehabilitation

Outcome Measures

Primary Outcomes (2)

  • The Jebsen-Taylor Test

    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

    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.

Study Arms (3)

Traditional techniques

ACTIVE COMPARATOR

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

traditional therapy with constraint induced movement therapy

EXPERIMENTAL

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

traditional therapy with constraint induced movement therapy and virtual reality

EXPERIMENTAL

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

Interventions

TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality

traditional therapy with constraint induced movement therapy and virtual reality
TT+CIMTOTHER

TT: Traditional Techniques CIMT: constraint-induced movement therapy

traditional therapy with constraint induced movement therapy
TTOTHER

TT: Traditional Techniques

Traditional techniques

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar Universty

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra((R)) arm splints improve movement fluency in children with cerebral palsy. Gait Posture. 2011 Feb;33(2):214-9. doi: 10.1016/j.gaitpost.2010.11.008. Epub 2010 Dec 4.

    PMID: 21131201BACKGROUND
  • Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.

    PMID: 30932166BACKGROUND
  • Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.

    PMID: 19451190BACKGROUND
  • Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.

    PMID: 19489088BACKGROUND
  • Jung SH, Song SH, Kim SD, Lee K, Lee GC. Does virtual reality training using the Xbox Kinect have a positive effect on physical functioning in children with spastic cerebral palsy? A case series. J Pediatr Rehabil Med. 2018;11(2):95-101. doi: 10.3233/PRM-160415.

    PMID: 30010148BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Esin KADIKOYLU, Pt

    Uskudar University

    STUDY CHAIR
  • Eren DEMIRAYAK, Pt

    Uskudar University

    STUDY CHAIR
  • Cetin Sayaca, Assoc. Prof.

    Uludag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Assos. Prof.

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

October 13, 2023

Primary Completion

March 10, 2024

Study Completion

March 12, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations