Taping in Children With Cerebral Palsy

NCT ID: NCT03296865

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2016-03-01

Brief Summary

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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

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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

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

We used a blinded and repeated-measure design, with the application of a placebo condition
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Without taping

Evaluations without taping

Group Type NO_INTERVENTION

No interventions assigned to this group

Kinesio taping

Kinesio taping was apllied only one time. It was removed after intervention.

Group Type EXPERIMENTAL

Kinesio taping

Intervention Type DEVICE

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.

Placebo

Placebo was apllied only one time. It was removed after intervention.

Group Type PLACEBO_COMPARATOR

Kinesio taping

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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taping

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Adriana Neves Dos Santos

OTHER

Sponsor Role lead

Responsible Party

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Adriana Neves Dos Santos

Professor, Reseacher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nelci Adriana Cicuto Ferreira Rocha, Phd

Role: STUDY_DIRECTOR

Universidade de São Carlos

Locations

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Universidade Federal de São Carlos

São Carlos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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fapesc2012/10558-6

Identifier Type: -

Identifier Source: org_study_id