NCT04932538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 1, 2021

Last Update Submit

June 18, 2021

Conditions

Keywords

cerebral palsygaitbalancekinesio taping

Outcome Measures

Primary Outcomes (6)

  • Pediatric Berg Balance Scale (PBBS)

    Balance was evaluated with the Pediatric Berg Balance Scale (PBBS).On this scale minimum score is 0 and maximum score is 56. As the score increases, the balance improves. Between baseline and fourth week the balance change was assessed.

    baseline and after 4 weeks

  • Timed Up and Go test (TUG)

    The TUG measures various components such as walking speed, postural control, functional mobility, and balance. Change in functionality was assessed between baseline, 30 minutes after the first taping, and at the fourth week.

    baseline, 30 minutes after the first tape was applied, and at the end of the 4th week

  • Functional Mobility Scale (FMS)

    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.On this scale the minimum score is 1, and the maximum score is six. The higher the score, the better the functional status.Change in functionality was assessed between baseline and at the fourth week.

    baseline and after 4 weeks

  • Gross Motor Function Measurement (GMFM)

    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. Minimum score is 0 and maximum score is 74. The higher the score, the better the functional status. Between baseline and fourth week the motor performance change was assessed.

    baseline and after 4 weeks

  • BTS G-Walk Spatiotemporal Gait Analysis System

    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 (11). 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. Change in gait parameters was assessed between baseline, 30 minutes after first taping and at the fourth week.

    baseline, 30 minutes after the first tape was applied, and at the end of the 4th week

  • Canadian Occupational Performance Measure (COPM)

    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.There is no minimum maximum score on this scale. The pre- and post-treatment scores of the person are compared. Between baseline and fourth week the participation change was assessed.

    baseline and after 4 weeks

Study Arms (2)

Control Group

NO 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.

Kinesio Taping

EXPERIMENTAL

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.

Other: Kİnesio Taping

Interventions

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

Kinesio Taping

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • being able to follow and accept verbal instructions.

You may not qualify if:

  • having any orthopedic surgery or botulinum toxin injection in the past 6 months
  • having allergic reactions to the adhesive compound of Kinesio Taping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Nur KEMER,PT, MSc

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Master of Science, Lecturer, Principal İnvestigator

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 21, 2021

Study Start

August 15, 2020

Primary Completion

December 30, 2020

Study Completion

March 15, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations