Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04932538 |
| Other study ID # |
A7698 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2020 |
| Est. completion date |
March 15, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
BACKGROUND: Walking and balance problems are among the most common problems in individuals
with cerebral palsy (CP). Hip abduction and extension muscle function insufficiencies are
common in children with CP.
OBJECTIVE: The aim of this study was to investigate the immediate and long-term effects of
Kinesio® Taping (KT) applied on the gluteus maximus and gluteus medius muscles on walking,
functionality, balance, and participation in children with unilateral spastic CP.
METHOD: This study was designed as a randomized controlled trial. The study included 20
children with unilateral spastic CP: 11 in the taping group and 9 in the control group. KT
was applied in the taping group for 4 weeks in addition to a physiotherapy program. The
control group received only the physiotherapy program. Body structure and functions were
evaluated with the Pediatric Berg Balance Scale (PBBS). Activity was evaluated with the Timed
Up and Go Test (TUG), Functional Mobility Scale (FMS), Gross Motor Function Scale (GMFM-88),
the BTS G-Walk Spatiotemporal Gait Analysis System. Participation was evaluated with the
Canadian Occupational Performance Measure (COPM). Evaluations were made at the beginning of
the study and 30 minutes after the first tape application, and at the end of 4 weeks in the
taping group. The level of significance was accepted as p<0.05.
Description:
INTRODUCTION Walking and balance problems are frequently seen in individuals with cerebral
palsy (CP). In individuals with CP, co-contraction of the distal and proximal muscles
increase and muscle activation patterns are not fluent. Spasticity causes a decrease in
muscle strength and length and a reduction in muscular coordination. Secondary to all this,
decreases are seen in the energy production of the muscles.
Insufficiencies in hip abduction and extension muscle function are common in CP. Excessive
muscles tonus in the hip adductors and flexors and a loss of reciprocal inhibition cause a
weakness in the gluteus medius and maximus. This weakness negatively affects the movement
patterns of the lumbar spine, pelvis, and hip region, and also causes incorrect loadings in
hip joint and abnormalities in hip biomechanics. Gait anomalies occur and pelvis
stabilization is impaired. In particular, negative impacts on participation are a concern.
With the physiotherapy and rehabilitation approaches, these negative effects may be minimized
by facilitating the gluteal muscles. Gait training and exercises to strengthen the gluteal
muscles are routinely used in the rehabilitation of CP. With these approaches, it is aimed to
maximize the gait function and promote independence and participation.
The somatosensory system may be affected in unilateral spastic CP. These children often
suffer sensory impairments that could affect the development of future motor skills. Kinesio
Taping® (KT) is used for pediatric rehabilitation to reduce pain, facilitate or inhibit
muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support
postural alignment, and improve proprioception.
Yasukawa et al. stated that the use of KT for children with CP might influence the cutaneous
receptors of the sensory motor system, resulting in an improvement in voluntary control and
coordination via a physiotherapy program. Therefore, facilitating the gluteal muscles by KT
may affect walking and balance positively.
In the literature, the clinical use of KT techniques in children with CP is generally at the
upper extremity. In studies in which KT is applied to the lower extremity, it is generally
applied to the distal part of extremity. In addition, most of the studies have investigated
the immediate effect. There are few studies investigating the effects of KT applied to the
gluteus medius and gluteus maximus muscles, which are located in the proximal hip with
important contributions in stabilization.
The aim of this study was to investigate the immediate and long-term effects of KT applied to
the gluteus maximus and gluteus medius muscles on walking, functionality, balance, and
participation in children with unilateral spastic CP.
MATERIAL AND METHODS The permission of the University Ethics Committee was received
(91610558-302.08.01) and written informed consent was obtained from each participant and/or
guardian.
Participants
The inclusion criteria were: having unilateral spastic CP; being in an age between 6 years
and 12 years; being classified in levels I or II of the Gross Motor Function Classification
System (GMFCS); having spasticity at lower extremity 2 or less according to Modified Ashworth
Scale, and being able to follow and accept verbal instructions. The exclusion criteria were
having any orthopedic surgery or botulinum toxin injection in the past 6 months and having
allergic reactions to the adhesive compound of KT.
Procedure
This study was designed as a randomized controlled trial. Twenty children (10 girls, 10 boys)
were included in the study. The children were divided into two randomized groups using a
computer program. Of the 20 participants, 11 were randomized to the taping group and 9 to the
control group.
Measurements In the taping group, measurements were made at the beginning of the study, 30
minutes after the first tape was applied, and at the end of the 4th week. In the control
group, measurements were made at the beginning of the study and at the end of the 4th week.
The BTS G-Walk Spatiotemporal Gait Analysis System was administered by the third author (S.
Ö.). All other measurements were administered by the same physiotherapist (S. N. K.). Gross
motor function was classified using the GMFCS.
Body Structures and Functions Body composition was evaluated by body mass index (BMI)
calculated with the following formula: weight in kilograms divided by the square of the
height in meters. Balance was evaluated with the Pediatric Berg Balance Scale (PBBS).
Activity functioning Functionality was assessed using the Timed Up and Go test (TUG) and the
Functional Mobility Scale (FMS). The TUG measures various components such as walking speed,
postural control, functional mobility, and balance . The walking ability of the participants
was evaluated with the Functional Mobility Scale at 3 different distances (5 meters-indoor,
50 meters-school, 500 meters-community). Inter-observer reliability of the FMS, which can
reveal changes that cannot be detected with the GMFCS, was also demonstrated. Gross motor
function was assessed using dimensions D and E of the Gross Motor Function Measurement
(GMFM), which consists of standing, walking, running, and jumping. The GMFM is a valid,
reliable, and sensitive method, which demonstrates the change in motor functions in children
with CP and other disabilities via videotape recordings.
Gait parameters were assessed using the BTS G-Walk Spatiotemporal Gait Analysis System. In
this system, the analysis results of the sensor attached to the L5-S1 level of the patient
was transferred to a computer via Bluetooth. This system allows gait analysis by comparing
the left and right extremities with normal values, and it also enables a 3-dimensional
kinematic analysis of the pelvis. The track length was preset as 10 meters. The children with
CP were asked to walk the 10-meter track three times. Three measurements were averaged in the
analysis.
Participation Participation was assessed using the Canadian Occupational Performance Measure
(COPM). The COPM is a client-centered outcome measure to identify and prioritize everyday
issues that restrict individuals' participation in everyday life.
Intervention
Every group received routine traditional physiotherapy twice a week over the period of 4
weeks. This routine traditional treatment consisted of stretching, weight bearing, functional
reaching, walking, and electrotherapy. Sessions were 40 minutes. The children in the taping
group were taped 6 days per week for 4 weeks. The children were checked for allergies before
applying the tape. A 5-cm tape was applied and kept in position for 3 days, and the region
was then left to rest for 24 hours.
KT was applied to the gluteus maximus and gluteus medius muscles. The KT muscle facilitation
technique was used to support and facilitate the function of the muscles. For the gluteus
maximus, a "Y" tape was used. The child was placed in a side lying position and the beginning
of the tape was applied to the origin of the muscle (center of the sacrum). The leg flexed
and adducted, and the first tail was applied to enclose the lower part of the gluteus maximus
muscle. The second tail was applied diagonally from the sacrum to the greater trochanter. For
the gluteus medius muscle, 2 "I" tapes were applied. The first tape was applied from the
spina iliaca anterior superior to the greater trochanter, the second tape was applied from
the spina iliaca posterior superior to the greater trochanter. During the applications, the
hip was adducted and extended, and all tape ends were applied without tension.
Statistical analysis Post-hoc power analysis was performed when 20 participants (11 in the
taping group, 9 in the control group) were enrolled in our study. Power analysis was
conducted using G*Power (version 3.0.10 Universitat Düsseldorf, Düsseldorf, Germany) to
compare pairs of independent sample means. In the post-hoc power analysis, when the
statistical significance of alpha was 5% and the confidence interval was 95%, the power of
the study (1-β) was found to be 99%. The study was completed by deciding that a sufficient
sample size was reached. The Statistical Package for the Social Sciences (SPSS) version 26
was used to analyze the obtained data. The level of significance was set at p<0.05.
One-sample Kolmogorov-Smirnov Tests were used to evaluate distribution of variables before
test selection. Descriptive analyses are presented using medians and the interquartile ranges
for the non-normally distributed and ordinal variables. In the comparison of two independent
nominal variables, while the Chi-Square Test was used, the Fisher Test was preferred
according to the expected values in the table cells. The Mann-Whitney U test was used to
compare non-normally distributed ordinal data in independent groups. The Wilcoxon Signed
Ranks Test or the Friedman was used in dependent groups. The Student's t-test was used to
compare normally distributed numerical data. Repeated Measures Anova was used to compare
normally distributed numerical data in more than two dependent groups. Groups were compared
with each other using the paired T test.
