Cerebral PalsyNCT05988944
The Hand Functions In Cerebral Palsy
A study testing TT+CIMT+VR, TT+CIMT and TT in people with Cerebral Palsy and Hand Functions, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Hand Functions
- What is being tested?
- TT+CIMT+VR, TT+CIMT and TT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2023to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Cerebral Palsy, Hand Functions
- Being tested
- TT+CIMT+VR, TT+CIMT, TT
- Keywords
- Hand Functions, Virtual Reality, Constraint-Induced Movement Therapy, Cerebral Palsy, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT+CIMT+VROther
TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality
TT+CIMTOther
TT: Traditional Techniques CIMT: constraint-induced movement therapy
TTOther
TT: Traditional Techniques
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: TT+CIMT+VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start13 Oct 2023
- Primary completion10 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cetin Sayaca, Uludag University
- Investigators
- Esin KADIKOYLU, Pt, Study chair, Uskudar UniversityEren DEMIRAYAK, Pt, Study chair, Uskudar UniversityCetin Sayaca, Assoc. Prof., Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988944
- Sponsor's protocol ID
- CIMT vs VR
- Status last verified
- Mar 2024
- First submitted
- 4 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21131201Hoare 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.
PubMed 30932166Sakzewski 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.
PubMed 19451190Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
PubMed 19489088Jung 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.
PubMed 30010148
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05988944
- Acronym / sponsor ID
- CIMT vs VR
- Conditions
- Cerebral Palsy, Hand Functions
- Keywords
- Hand Functions, Virtual Reality, Constraint-Induced Movement Therapy, Cerebral Palsy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional techniques | Active comparator | Other: TTTT 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 | Experimental | Other: TT+CIMTThe 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 | Experimental | Other: TT+CIMT+VRAfter 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TT+CIMT+VRTT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality | Other | traditional therapy with constraint induced movement therapy and virtual reality |
| TT+CIMTTT: Traditional Techniques CIMT: constraint-induced movement therapy | Other | traditional therapy with constraint induced movement therapy |
| TTTT: Traditional Techniques | Other | Traditional techniques |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 21131201Elliott 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.
- Background: PubMed 30932166Hoare 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.
- Background: PubMed 19451190Sakzewski 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.
- Background: PubMed 19489088Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
- Background: PubMed 30010148Jung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin KADIKOYLU, Pt study chair
Uskudar University
Eren DEMIRAYAK, Pt study chair
Uskudar University
Cetin Sayaca, Assoc. Prof. principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TT+CIMT+VR, TT+CIMT and TT in people with Cerebral Palsy and Hand Functions, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Jebsen-Taylor Test (time frame: this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05988944, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.