Taping in Children With Cerebral Palsy

NCT03296865 | Completed DMC

• 1 other identifier: fapesc2012/10558-6
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

taping; functionality; rehabilitation; muscle activity; electromyography

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  change measures (2 days, 3 measures)

• Time used to perform sit to stand movement

  Time in seconds from kinematics evaluation

  change measures (2 days, 3 measures)

Study Arms (3)

Without taping

NO INTERVENTION

Evaluations without taping

Kinesio taping

EXPERIMENTAL

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

Device: Kinesio taping

Placebo

PLACEBO COMPARATOR

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

Device: Kinesio taping

Interventions

Kinesio taping 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.

Also known as: taping

Kinesio taping; Placebo

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adriana Neves Dos Santos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nelci Adriana Cicuto Ferreira Rocha, Phd

  Universidade de São Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Reseacher

Model Details: We used a blinded and repeated-measure design, with the application of a placebo condition

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: March 1, 2014
• Primary Completion: March 3, 2015
• Study Completion: March 1, 2016
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One year after study completion

Locations

BR (1)