Clinical trial NCT03296865: Taping in Children With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: taping
functionality
rehabilitation
muscle activity
electromyography
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-09-28
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We used a blinded and repeated-measure design, with the application of a placebo condition
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Rectus femoris muscle activity
timeFrame: change measures (2 days, 3 measures)
measure: Trunk and lower limbs alignment (kinematics)
timeFrame: change measures (2 days, 3 measures)
measure: Time used to perform sit to stand movement
timeFrame: change measures (2 days, 3 measures)
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de São Carlos
state: São Paulo
Study officials:
affiliation: Universidade de São Carlos
name: Nelci Adriana Cicuto Ferreira Rocha, Phd
role: STUDY_DIRECTOR
References: