Cerebral PalsyNCT03403322
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
A study testing Kinesio taping and Without taping in people with Cerebral Palsy, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
Children with Cerebral Palsy (CP) present limited performance of functional activities and activities of daily life. Kinesio taping has been definied as a promising technique for children with CP ans has been extensively used in clinical practice. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Kinesio taping and Without taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2016to 30 Dec 2017
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with spastic CP
- aged from 5 to 18 years
- Gross Motor Function Classification System levels I and II
- able to understand simple commands
- able to perform the sit-to-stand movement without support
Who cannot join
- muscle shortening in hamstring, gastrocnemius and hip flexors
- deformities in the lower limbs such as fixed hip and knee flexion that could compromise the sit-to-stand movement
- surgical procedures in the lower limbs and trunk in the previous 12 months
- botulinum toxin injection in the previous 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Santa Catarina
Araranguá, Santa Catarina, 88.906-072
About this study
Official title: Imediate Effects of Kinesio Tapin in Muscle Activity and Time to Perform Sit to Stand Movement in Children With Cerebral Palsy
Children with Cerebral Palsy (CP) present limited performance of functional activities and activities of daily life. Kinesio taping has been definied as a promising technique for children with CP ans has been extensively used in clinical practice. However, several studies have found a low level of evidence of its effectiveness in healthy individuals. We aim to evaluate the effects of the immediate application of Kinesio taping on the activation of the rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- Kinesio taping, Without taping
- Keywords
- intervention, children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
An experienced physiotherapist placed the base of the Kinesio taping strip, over rectus femoris muscle, 3cm bellow the anterior iliac spine, without tension. From this point, the Kinesio taping was placed up to the upper edge of the patella and stretched to 100% tension. It was, then, bi-sectioned, circled the patella and ended in the tuberosity of the femur, without tension. In order to avoid interference in the electromyography signals, a section was held at Kinesio taping at the point where the electrode was placed.
Without tapingOther
Children performed functional activities without tape
| Study group | Role | What they receive |
|---|---|---|
| First test | Other | All measures were evaluated Receives: Other: Kinesio taping; Other: Without taping |
| Second test | Other | All measures were evaluated Receives: Other: Kinesio taping; Other: Without taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity
An electromyography analysis was performed to evaluate the rectus femoris and tibialis anterior activity during the sit-to-stand movement and the five time sit-to-stand test. Electrodes were placed in both lower limbs. Mean root mean square (mRMS) values were used for statistical analysis. Mean root mean square values were normalized by the maximum value of each trial and individual.
Measured: on the day of evaluation
Time to perform sit to stand
Children were seated with hip, knee and ankle flexed at 90°. Both feet were symmetrically positioned shoulder width apart and arms were crossed over the chest. Children should get up from the seat after the verbal command of the evaluator. Children performed the sit-to-stand movement at a speed that simulated the one usually adopted in daily routine
Measured: on the day of evaluation
Time to perform five time sit-to-stand test
Children had to get up and sit down five times as fast as possible. The instructions before starting the test were: "Stand up and sit down as quickly as possible for 5 times. The test will be finished when you return to the seated position the 5th time. Continue the sit-to-stand movement until I ask you to stop. If you try but cannot stand up, just let me know. Ready? go!"
Measured: on the day of evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Apr 2016
- Primary completion30 Aug 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Neves Dos Santos, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403322
- Sponsor's protocol ID
- UFSC-SIGPEX / 201702940
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imediate Effects of Kinesio Tapin in Muscle Activity and Time to Perform Sit to Stand Movement in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03403322
- Acronym / sponsor ID
- UFSC-SIGPEX / 201702940
- Conditions
- Cerebral Palsy
- Keywords
- intervention, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 18 Jan 2018 (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.
Children with Cerebral Palsy (CP) present limited performance of functional activities and activities of daily life. Kinesio taping has been definied as a promising technique for children with CP ans has been extensively used in clinical practice. However, several studies have found a low level of evidence of its effectiveness in healthy individuals. We aim to evaluate the effects of the immediate application of Kinesio taping on the activation of the rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First test | Other | Other: Kinesio taping, Other: Without tapingAll measures were evaluated |
| Second test | Other | Other: Kinesio taping, Other: Without tapingAll measures were evaluated |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- diagnosed with spastic CP
- aged from 5 to 18 years
- Gross Motor Function Classification System levels I and II
- able to understand simple commands
- able to perform the sit-to-stand movement without support
Key exclusion criteria (4 listed)
- muscle shortening in hamstring, gastrocnemius and hip flexors
- deformities in the lower limbs such as fixed hip and knee flexion that could compromise the sit-to-stand movement
- surgical procedures in the lower limbs and trunk in the previous 12 months
- botulinum toxin injection in the previous 6 months
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 |
|---|---|---|
| Kinesio tapingAn experienced physiotherapist placed the base of the Kinesio taping strip, over rectus femoris muscle, 3cm bellow the anterior iliac spine, without tension. From this point, the Kinesio taping was placed up to the upper edge of the patella and stretched to 100% tension. It was, then, bi-sectioned, circled the patella and ended in the tuberosity of the femur, without tension. In order to avoid interference in the electromyography signals, a section was held at Kinesio taping at the point where the electrode was placed. | Other | First test, Second test |
| Without tapingChildren performed functional activities without tape | Other | First test, Second test |
Primary outcome
Muscle activity
Time frame: on the day of evaluation
An electromyography analysis was performed to evaluate the rectus femoris and tibialis anterior activity during the sit-to-stand movement and the five time sit-to-stand test. Electrodes were placed in both lower limbs. Mean root mean square (mRMS) values were used for statistical analysis. Mean root mean square values were normalized by the maximum value of each trial and individual.
Time to perform sit to stand
Time frame: on the day of evaluation
Children were seated with hip, knee and ankle flexed at 90°. Both feet were symmetrically positioned shoulder width apart and arms were crossed over the chest. Children should get up from the seat after the verbal command of the evaluator. Children performed the sit-to-stand movement at a speed that simulated the one usually adopted in daily routine
Time to perform five time sit-to-stand test
Time frame: on the day of evaluation
Children had to get up and sit down five times as fast as possible. The instructions before starting the test were: "Stand up and sit down as quickly as possible for 5 times. The test will be finished when you return to the seated position the 5th time. Continue the sit-to-stand movement until I ask you to stop. If you try but cannot stand up, just let me know. Ready? go!"
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 18 Jan 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Without taping in people with Cerebral Palsy, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
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 5 inclusion and 4 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 18 Jan 2018. 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 Brazil. 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?
Muscle activity (time frame: on the day of evaluation). The study lists 3 primary outcomes in all. 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 18 Jan 2018.