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Taping in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03296865
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Adriana Neves Dos Santos, Universidade Federal de Santa Catarina

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Kinesio taping Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: We used a blinded and repeated-measure design, with the application of a placebo condition
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Children and the person that performed the evaluation were blind only to KT and placebo conditions, since they did not know if KT was tensioned were not. The person that performed data analysis was blind to all conditions.
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : March 3, 2015
Actual Study Completion Date : March 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Without taping
Evaluations without taping
Experimental: Kinesio taping
Kinesio taping was apllied only one time. It was removed after intervention.
Device: Kinesio 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.

Other Name: taping

Placebo Comparator: Placebo
Placebo was apllied only one time. It was removed after intervention.
Device: Kinesio 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.

Other Name: taping




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. Time used to perform sit to stand movement [ Time Frame: change measures (2 days, 3 measures) ]
    Time in seconds from kinematics evaluation



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296865


Locations
Brazil
Universidade Federal de São Carlos
São Carlos, São Paulo, Brazil, 13565-905
Sponsors and Collaborators
Adriana Neves Dos Santos
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Nelci Adriana Cicuto Ferreira Rocha, Phd Universidade de São Carlos

Responsible Party: Adriana Neves Dos Santos, Professor, Reseacher, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT03296865     History of Changes
Other Study ID Numbers: fapesc2012/10558-6
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary outcomes will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: One year after study completion
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adriana Neves Dos Santos, Universidade Federal de Santa Catarina:
taping
functionality
rehabilitation
muscle activity
electromyography

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases