NCT04425811

Brief Summary

The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

June 4, 2020

Last Update Submit

June 8, 2020

Conditions

Keywords

StrokeKinesiological TapingWalkingTibialis Anterior

Outcome Measures

Primary Outcomes (1)

  • non-taping walking parameter measurement

    The dominant side lower extremity of the participants was determined as the first preferred lower limb to take steps when walking. Walking parameters of the participants included in the study were evaluated with BTS G-Walk Spatio-Temporal Gait Analysis System. Before the banding applications of the patients, walking parameters were measured by asking them to walk with a shoe that they always use daily with the command "walk normally" on a 10-meter course, and stop with the command "stop" after 10 meters.

    2 hours

Secondary Outcomes (2)

  • With kinesiological taping walking parameter measurement

    2 hours

  • With sham taping walking parameter measurement

    2 hours

Study Arms (3)

No tape applied

NO INTERVENTION

Walking parameters were evaluated without any intervention.

Kinesiological Tape

EXPERIMENTAL

Walking parameters were evaluated after kinesiological taping on the tibialis anterior muscle

Other: kinesiological taping

Sham taping

SHAM COMPARATOR

Walking parameters were evaluated after sham taping on the tibialis anterior muscle

Other: kinesiological taping

Interventions

The kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control.

Kinesiological TapeSham taping

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke individuals (hemiplegic / hemiparetic) who were treated in the Adult
  • Neurological Rehabilitation Unit of Pamukkale University Medical Faculty Hospital were included in the study.
  • Being between the ages of 25-70
  • Volunteers with written consent
  • With a 1-year history of stroke
  • Who had a stroke for the first time
  • Having a lesion in one brain hemisphere

You may not qualify if:

  • Having neurological or orthopedic comorbid disease
  • Patients with a gastrocnemius spasticity greater than 2 according to the modified ashworth scale
  • Patients with communication problems
  • Patients with cognitive functions below 7 points according to the Hodkinson Mental Test
  • Patients with ambulation level below 3 according to Functional Ambulation Classification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Emre Baskan, Phd

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Original kinesiological tape was applied to the participants. Then sham banding application was done with sticking plaster tape.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Sham Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

June 14, 2018

Primary Completion

July 22, 2019

Study Completion

May 5, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations