Cerebral PalsyNCT03296865
Taping in Children With Cerebral Palsy
A study testing Kinesio taping in people with Cerebral Palsy, run by Adriana Neves Dos Santos at 1 site in Brazil.
Trial summary
Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in children with spastic UCP (USCP). Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Kinesio taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2014to 1 Mar 2016
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with unilateral spastic Cerebral Palsy
- Aged from 6 and 12 years
- Ability to perform sit to stand movement without support in three seat heights
Who cannot join
- Ability to understand simple commands
- Muscle shortening in hamstrings, gastrocnemius and hip flexors
- Deformity in the lower limbs, such as fixed hip and knee flexion, that could compromise STS
- Surgical procedures in lower limbs and trunk in previous 12 months
- Botulinum toxin injection in lower limbs in the previous 6 months
- Not attending physical therapy at least 2 times a week during the last 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Effects of Kinesio Taping in Rectus Femoris Activity and Sit-to-stand Movement in Children With Unilateral Cerebral Palsy: Placebo-controlled, Repeated-measure Design
Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in children with spastic UCP (USCP). A blinded, placebo and repeated-measure design was applied. The setting was the rehabilitation clinic of the university and care facilities. Eleven children, aged from 6 to 12 years old (10.5±-2.8 years), diagnosed with USCP, Gross Motor Function Classification System levels I and II were evaluated. KT was applied over rectus femoris (RF) muscle of the affected limb. We considered three taping conditions: KT, without KT (with tension) and placebo (KT without tension). Mean root mean square (mRMS) of RF; initial, final and peak angles, and range of motion of trunk, pelvis, hip, knee and ankles joints; and total duration of STS were considered. STS was evaluated from three seat heights, neutral (100%), lowered (80%) and elevated (120%). Mixed ANOVA test was applied for angular variables of hip, knee and ankle, and mRMS of RF. Repeated ANOVA was applied for angular variables of trunk and pelvis, total duration.
Read the detailed description
We evaluated a non-probability convenience sample. Participants were recruited in the rehabilitation clinic of the university and care facilities, between July of 2013 and July of 2014.
Body structures and functions and functionality component of the International Classification of Functioning, Disability and Healthy, were evaluated. Muscle activity (electromyography) and trunk and lower limbs alignment (kinematics) were evaluated as body structures and functions measures. Time used to perform STS was used as functionality measure.
We evaluated sit to stand in three conditions: a) without taping; b) with KT, which was characterized as the use of KT with tension; c) placebo.
Baseline measurement: STS without taping. The child was seated in a seat with adjustable height, without shoes. Both feet were symmetrically positioned shoulder width apart and arms were crossed over the chest. The participants could not use their arms to push up off the chair. Also, the child should be seated with gluteal and the upper thighs regions supported in seat. Children performed STS in a speed that simulated the one usually adopted in daily routine.
Baseline measurement was evaluated in three seat heights: neutral, elevated and lowered. Neutral corresponded to a seated position with 90° of hip, knee and ankle flexion. Lowered and elevated were defined as, respectively, 80 and 120% of neutral height.The order of seat heights was randomized by drawing lots. A interval of 5 minutes was allowed between each seat height.
Evaluations were carried out in two testing episodes, with one-week interval between them. On the first day, additional to baseline, the child performed STS with KT or placebo. The determination of which tape condition would be applied was randomized by drawing lots. A 15-minute interval between baseline and tape condition was established. On the second day, the tape condition that was not performed on the first day was evaluated. In all conditions, the child performed STS in three seat heights.
- Conditions
- Cerebral Palsy
- Being tested
- Kinesio taping
- Keywords
- taping, functionality, rehabilitation, muscle activity, electromyography
- 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 tapingDevice
Also called taping
We applied a hypoallergenic, porous and adhesive tape of cotton (Kinesio Tex Gold) placed over Rectus Femoris muscle of the affected limb. Children were taped in accordance to Kenzo Kase's Kinesio manual. We used a facilitation technique, from muscle origin to insertion, in a Y shape. For KT condition: base of the KT strip 3cm below the anterior iliac spine, over the RF muscle until the upper edge of the patella and stretchered with 100% tension. For placebo condition: same technique without tension in the entire tape.
We verified the immediate effect of KT/placebo. After the evaluation, KT/placebo was removed.
| Study group | Role | What they receive |
|---|---|---|
| Without taping | No intervention | Evaluations without taping |
| Kinesio taping | Experimental | Kinesio taping was apllied only one time. It was removed after intervention. Receives: Device: Kinesio taping |
| Placebo | Placebo comparator | Placebo was apllied only one time. It was removed after intervention. Receives: Device: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus femoris muscle activity
A portable surface electromyography (Trigno™ Wireless EMG System, DelSys®, Boston, USA) was used to evaluate RF activity (sampling 2400Hz).
Electrode was positioned at RF of both limbs while the child was lying in supine. Skin preparation and electrode placement were performed according to SENIAM guidelines.
Measured: change measures (2 days, 3 measures)
Trunk and lower limbs alignment (kinematics)
A six-camera motion analysis system Qualisys ProReflex MCU (QUALISYS-MEDICAL AB®, Gothenburg, Sweden) recorded body kinematics (sampling 240Hz). 27 non co-linear passive markers (15mm) were placed.
Angular variation of trunk, pelvis, hip, knee and ankle were assessed using the Visual 3D software. We considered initial, final and peak angles. We also evaluated range of motion defined as the difference between final and initial angles.
Measured: change measures (2 days, 3 measures)
Time used to perform sit to stand movement
Time in seconds from kinematics evaluation
Measured: change measures (2 days, 3 measures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Mar 2014
- Primary completion3 Mar 2015
- Study completion1 Mar 2016
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
- Model description
- We used a blinded and repeated-measure design, with the application of a placebo condition
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adriana Neves Dos Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Adriana Neves Dos Santos, Universidade Federal de Santa Catarina
- Investigators
- Nelci Adriana Cicuto Ferreira Rocha, Phd, Study director, Universidade de São Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296865
- Sponsor's protocol ID
- fapesc2012/10558-6
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 2 Oct 2017
- 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 outcomes will be made available
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping in Rectus Femoris Activity and Sit-to-stand Movement in Children With Unilateral Cerebral Palsy: Placebo-controlled, Repeated-measure Design
- ClinicalTrials.gov ID
- NCT03296865
- Acronym / sponsor ID
- fapesc2012/10558-6
- Conditions
- Cerebral Palsy
- Keywords
- taping, functionality, rehabilitation, muscle activity, electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Adriana Neves Dos SantosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 3 Mar 2015 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 28 Sep 2017 (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.
Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in children with spastic UCP (USCP). A blinded, placebo and repeated-measure design was applied. The setting was the rehabilitation clinic of the university and care facilities. Eleven children, aged from 6 to 12 years old (10.5±-2.8 years), diagnosed with USCP, Gross Motor Function Classification System levels I and II were evaluated. KT was applied over rectus femoris (RF) muscle of the affected limb. We considered three taping conditions: KT, without KT (with tension) and placebo (KT without tension). Mean root mean square (mRMS) of RF; initial, final and peak angles, and range of motion of trunk, pelvis, hip, knee and ankles joints; and total duration of STS were considered. STS was evaluated from three seat heights, neutral (100%), lowered (80%) and elevated (120%). Mixed ANOVA test was applied for angular variables of hip, knee and ankle, and mRMS of RF. Repeated ANOVA was applied for angular variables of trunk and pelvis, total duration.
Detailed description
We evaluated a non-probability convenience sample. Participants were recruited in the rehabilitation clinic of the university and care facilities, between July of 2013 and July of 2014.
Body structures and functions and functionality component of the International Classification of Functioning, Disability and Healthy, were evaluated. Muscle activity (electromyography) and trunk and lower limbs alignment (kinematics) were evaluated as body structures and functions measures. Time used to perform STS was used as functionality measure.
We evaluated sit to stand in three conditions: a) without taping; b) with KT, which was characterized as the use of KT with tension; c) placebo.
Baseline measurement: STS without taping. The child was seated in a seat with adjustable height, without shoes. Both feet were symmetrically positioned shoulder width apart and arms were crossed over the chest. The participants could not use their arms to push up off the chair. Also, the child should be seated with gluteal and the upper thighs regions supported in seat. Children performed STS in a speed that simulated the one usually adopted in daily routine.
Baseline measurement was evaluated in three seat heights: neutral, elevated and lowered. Neutral corresponded to a seated position with 90° of hip, knee and ankle flexion. Lowered and elevated were defined as, respectively, 80 and 120% of neutral height.The order of seat heights was randomized by drawing lots. A interval of 5 minutes was allowed between each seat height.
Evaluations were carried out in two testing episodes, with one-week interval between them. On the first day, additional to baseline, the child performed STS with KT or placebo. The determination of which tape condition would be applied was randomized by drawing lots. A 15-minute interval between baseline and tape condition was established. On the second day, the tape condition that was not performed on the first day was evaluated. In all conditions, the child performed STS in three seat heights.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- We used a blinded and repeated-measure design, with the application of a placebo condition
| Arm | Type | Receives |
|---|---|---|
| Without taping | No intervention | –Evaluations without taping |
| Kinesio taping | Experimental | Device: Kinesio tapingKinesio taping was apllied only one time. It was removed after intervention. |
| Placebo | Placebo comparator | Device: Kinesio tapingPlacebo was apllied only one time. It was removed after intervention. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with unilateral spastic Cerebral Palsy
- Aged from 6 and 12 years
- Ability to perform sit to stand movement without support in three seat heights
Key exclusion criteria (6 listed)
- Ability to understand simple commands
- Muscle shortening in hamstrings, gastrocnemius and hip flexors
- Deformity in the lower limbs, such as fixed hip and knee flexion, that could compromise STS
- Surgical procedures in lower limbs and trunk in previous 12 months
- Botulinum toxin injection in lower limbs 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 tapingAlso: tapingWe applied a hypoallergenic, porous and adhesive tape of cotton (Kinesio Tex Gold) placed over Rectus Femoris muscle of the affected limb. Children were taped in accordance to Kenzo Kase's Kinesio manual. We used a facilitation technique, from muscle origin to insertion, in a Y shape. For KT condition: base of the KT strip 3cm below the anterior iliac spine, over the RF muscle until the upper edge of the patella and stretchered with 100% tension. For placebo condition: same technique without tension in the entire tape. We verified the immediate effect of KT/placebo. After the evaluation, KT/placebo was removed. | Device | Kinesio taping, Placebo |
Primary outcome
Rectus femoris muscle activity
Time frame: change measures (2 days, 3 measures)
A portable surface electromyography (Trigno™ Wireless EMG System, DelSys®, Boston, USA) was used to evaluate RF activity (sampling 2400Hz). Electrode was positioned at RF of both limbs while the child was lying in supine. Skin preparation and electrode placement were performed according to SENIAM guidelines.
Trunk and lower limbs alignment (kinematics)
Time frame: change measures (2 days, 3 measures)
A six-camera motion analysis system Qualisys ProReflex MCU (QUALISYS-MEDICAL AB®, Gothenburg, Sweden) recorded body kinematics (sampling 240Hz). 27 non co-linear passive markers (15mm) were placed. Angular variation of trunk, pelvis, hip, knee and ankle were assessed using the Visual 3D software. We considered initial, final and peak angles. We also evaluated range of motion defined as the difference between final and initial angles.
Time used to perform sit to stand movement
Time frame: change measures (2 days, 3 measures)
Time in seconds from kinematics evaluation
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 2 Oct 2017.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary outcomes will be made 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.
Nelci Adriana Cicuto Ferreira Rocha, Phd study director
Universidade de São Carlos
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 in people with Cerebral Palsy, run by Adriana Neves Dos Santos 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 3 inclusion and 6 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 2 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
Rectus femoris muscle activity (time frame: change measures (2 days, 3 measures)). 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 2 Oct 2017.