Taping in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296865
• Other study ID #: fapesc2012/10558-6
• Status: Completed
• Phase: N/A
• First received: September 25, 2017
• Last updated: September 28, 2017
• Start date: March 1, 2014
• Est. completion date: March 1, 2016

Study information

• Verified date: September 2017
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 1, 2016
• Est. primary completion date: March 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Adriana Neves Dos Santos	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Time used to perform sit to stand movement	Time in seconds from kinematics evaluation	change measures (2 days, 3 measures)