Taping in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Kinesio taping
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring taping, functionality, rehabilitation, muscle activity, electromyography
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
Sites / Locations
- Universidade Federal de São Carlos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Placebo Comparator
Arm Label
Without taping
Kinesio taping
Placebo
Arm Description
Evaluations without taping
Kinesio taping was apllied only one time. It was removed after intervention.
Placebo was apllied only one time. It was removed after intervention.
Outcomes
Primary Outcome Measures
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.
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.
Time used to perform sit to stand movement
Time in seconds from kinematics evaluation
Secondary Outcome Measures
Full Information
NCT ID
NCT03296865
First Posted
September 25, 2017
Last Updated
September 28, 2017
Sponsor
Adriana Neves Dos Santos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03296865
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
March 3, 2015 (Actual)
Study Completion Date
March 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adriana Neves Dos Santos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
taping, functionality, rehabilitation, muscle activity, electromyography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
We used a blinded and repeated-measure design, with the application of a placebo condition
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without taping
Arm Type
No Intervention
Arm Description
Evaluations without taping
Arm Title
Kinesio taping
Arm Type
Experimental
Arm Description
Kinesio taping was apllied only one time. It was removed after intervention.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was apllied only one time. It was removed after intervention.
Intervention Type
Device
Intervention Name(s)
Kinesio taping
Other Intervention Name(s)
taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rectus femoris muscle activity
Description
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.
Time Frame
change measures (2 days, 3 measures)
Title
Trunk and lower limbs alignment (kinematics)
Description
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.
Time Frame
change measures (2 days, 3 measures)
Title
Time used to perform sit to stand movement
Description
Time in seconds from kinematics evaluation
Time Frame
change measures (2 days, 3 measures)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelci Adriana Cicuto Ferreira Rocha, Phd
Organizational Affiliation
Universidade de São Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary outcomes will be made available
IPD Sharing Time Frame
One year after study completion
Learn more about this trial
Taping in Children With Cerebral Palsy
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