The Hand Functions In Cerebral Palsy
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.
1 other identifier
interventional
45
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2024
CompletedMarch 13, 2024
March 1, 2024
5 months
August 4, 2023
March 12, 2024
Conditions
Keywords
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 COMPARATORTT 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.
traditional therapy with constraint induced movement therapy
EXPERIMENTALThe 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.
traditional therapy with constraint induced movement therapy and virtual reality
EXPERIMENTALAfter 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.
Interventions
TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality
TT: Traditional Techniques CIMT: constraint-induced movement therapy
Eligibility Criteria
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)
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: 21131201BACKGROUNDHoare 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: 30932166BACKGROUNDSakzewski 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: 19451190BACKGROUNDBrady 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: 19489088BACKGROUNDJung 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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Esin KADIKOYLU, Pt
Uskudar University
- STUDY CHAIR
Eren DEMIRAYAK, Pt
Uskudar University
- PRINCIPAL INVESTIGATOR
Cetin Sayaca, Assoc. Prof.
Uludag University
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