Back to resultsThe Hand Functions In Cerebral Palsy
Primary Purpose
Cerebral Palsy, Hand Functions
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TT+CIMT+VR
TT+CIMT
TT
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Hand Functions, Virtual Reality, Constraint-Induced Movement Therapy, Cerebral Palsy, Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Uskudar UniverstyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Traditional techniques
traditional therapy with constraint induced movement therapy
traditional therapy with constraint induced movement therapy and virtual reality
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05988944
Brief Title
The Hand Functions In Cerebral Palsy
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hand Functions
Keywords
Hand Functions, Virtual Reality, Constraint-Induced Movement Therapy, Cerebral Palsy, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional techniques
Arm Type
Active Comparator
Arm Description
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.
Arm Title
traditional therapy with constraint induced movement therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional therapy with constraint induced movement therapy and virtual reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TT+CIMT+VR
Intervention Description
TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality
Intervention Type
Other
Intervention Name(s)
TT+CIMT
Intervention Description
TT: Traditional Techniques CIMT: constraint-induced movement therapy
Intervention Type
Other
Intervention Name(s)
TT
Intervention Description
TT: Traditional Techniques
Primary Outcome Measure Information:
Title
The Jebsen-Taylor Test
Description
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.
Time Frame
this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
Title
Moberg pick-up test
Description
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.
Time Frame
this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cetin Sayaca, Assoc. Prof.
Phone
+90 543 621 8023
Email
cetinsayaca@uludag.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esin KADIKOYLU, Pt
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eren DEMIRAYAK, Pt
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cetin Sayaca, Assoc. Prof.
Organizational Affiliation
Uludag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uskudar Universty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cetin SAYACA
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21131201
Citation
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.
Results Reference
background
PubMed Identifier
30932166
Citation
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.
Results Reference
background
PubMed Identifier
19451190
Citation
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.
Results Reference
background
PubMed Identifier
19489088
Citation
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.
Results Reference
background
PubMed Identifier
30010148
Citation
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.
Results Reference
background
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The Hand Functions In Cerebral Palsy
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