SpasticityNCT02073513
Kinesiotaping the Hand in Cerebral Palsy
A study testing Kinesiotape plus thenar pressure (PPTG) and Taping Group (TG) in people with Spasticity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands. OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Spasticity
- What is being tested?
- Kinesiotape plus thenar pressure (PPTG) and Taping Group (TG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2009to Sep 2010
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Cerebral Palsy
- Stable clinical status
- Hand and/ or wrist spasticity
- No passive movement limitation
- Receiving regular neurodevelopmental rehabilitation
- Sufficient cognitive level
Who cannot join
- Surgery of the upper extremity
- Orthotic treatment
- Sensory deficit
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Ankara, 06100
About this study
Official title: Effects of Kinesiotaping the Hand of Children With Cerebral Palsy
BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.
OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure hand function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.
Read the detailed description
BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.
OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on upper extremity function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure upper extremity function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.
- Conditions
- Spasticity
- Being tested
- Kinesiotape plus thenar pressure (PPTG), Taping Group (TG)
- Keywords
- Spasticity, Hand Function, Cerebral Palsy, Kinesiotape
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotape plus thenar pressure (PPTG)Device
In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied to control the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied.
The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions.
Taping Group (TG)Device
In the taping group (TG) kinesiotape was applied to control the cortical thumb sign.
| Study group | Role | What they receive |
|---|---|---|
| kinesiotape plus thenar pressure (PPTG) | Experimental | In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied which controled the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied.
The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions. Receives: Device: Kinesiotape plus thenar pressure (PPTG) |
| Taping Group (TG) | Experimental | In the taping group (TG) kinesiotape was applied to control the cortical thumb sign. Receives: Device: Taping Group (TG) |
| Control Group (CG) | No intervention | No application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine hole peg test
Measured: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed
Secondary outcomes (1)
nine parts puzzle test
Measured: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hhotaman, Hacettepe University
- Investigators
- Fatma UYGUR, Prof. PhD., Study director, Hacettepe University Ethical Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073513
- Sponsor's protocol ID
- LUT 09/24-47
- Status last verified
- Feb 2014
- First submitted
- 12 Dec 2013
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesiotaping the Hand of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02073513
- Acronym / sponsor ID
- LUT 09/24-47
- Conditions
- Spasticity
- Keywords
- Spasticity, Hand Function, Cerebral Palsy, Kinesiotape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Feb 2014 (estimated)
- 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.
BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.
OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure hand function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.
Detailed description
BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.
OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on upper extremity function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure upper extremity function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kinesiotape plus thenar pressure (PPTG) | Experimental | Device: Kinesiotape plus thenar pressure (PPTG)In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied which controled the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied. The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions. |
| Taping Group (TG) | Experimental | Device: Taping Group (TG)In the taping group (TG) kinesiotape was applied to control the cortical thumb sign. |
| Control Group (CG) | No intervention | –No application. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Clinical diagnosis of Cerebral Palsy
- Stable clinical status
- Hand and/ or wrist spasticity
- No passive movement limitation
- Receiving regular neurodevelopmental rehabilitation
Key exclusion criteria (3 listed)
- Surgery of the upper extremity
- Orthotic treatment
- Sensory deficit
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 |
|---|---|---|
| Kinesiotape plus thenar pressure (PPTG)In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied to control the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied. The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions. | Device | kinesiotape plus thenar pressure (PPTG) |
| Taping Group (TG)In the taping group (TG) kinesiotape was applied to control the cortical thumb sign. | Device | Taping Group (TG) |
Primary outcome
Nine hole peg test
Time frame: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed
1 secondary outcome
nine parts puzzle test
Time frame: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed
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 27 Feb 2014.
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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.
Fatma UYGUR, Prof. PhD. study director
Hacettepe University Ethical Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape plus thenar pressure (PPTG) and Taping Group (TG) in people with Spasticity, run by Hacettepe 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?
The sponsor lists 6 inclusion and 3 exclusion criteria. 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 27 Feb 2014. 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?
Nine hole peg test (time frame: at baseline (before application), at 20 minutes after application, at 20 minutes after application removed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2014.