NCT05940792

Brief Summary

After a stroke, most patients have poor ankle control and difficulty walking. Considering that proper foot placement will provide a more balanced and controlled gait, the aim of this study was to investigate the immediate effect of non-elastic ankle taping providing eversion support on gait balance in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable stroke

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

July 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

June 20, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

balancegaitimmediatestroketaping

Outcome Measures

Primary Outcomes (1)

  • Dynamic Gait Index (DGI)

    The dynamic gait index includes 8 items: walking, walking at different speeds, crossing an obstacle, walking around an obstacle, suddenly turning 180 degrees while walking and stopping, climbing steps, walking by turning the head left and right in the horizontal plane, and walking by turning the head up and down in the vertical plane. The performance of each item was graded with 4 points. The score scale is as follows; 3 independent walking, 2 mild impairment, 1 moderate impairment and 0 severe impairment; the total score that can be obtained varies between 0-24 points. If the total score is between 22and24, it can be said that individuals have safe ambulation, 20-21 points are considered to be a harbinger of fall risk, and scores of 19 or lower have been associated with an increased incidence of falls

    5 months

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support.

Other: Nonelastic taping

control group

ACTIVE COMPARATOR

The control group received 45 min of conventional physiotherapy

Other: Conservative physiotherapy

Interventions

Non-elastic taping was placed on the ankle of the affected side with a plaster band starting from the middle of the sole of the foot and extending from the lateral side of the foot to the level below the knee to provide eversion support.

intervention group

The conventional physiotherapy programme included range of motion exercises, balance and gait training and neuromuscular electrical stimulation.

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having a stroke diagnosis at least 6 months ago,
  • being between the ages of 18 and 75,
  • having a spasticity grade of 0, 1, 1+, 2 according to the Modified Ashworth Scale,
  • having no cooperation problems and being mobilized without support.

You may not qualify if:

  • orthopedic problems such as surgical intervention, fracture history, presence of cognitive, visual, or cardiovascular diseases
  • skin sensitivity in the foot and ankle that may affect gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Beyzanur Dikmen Hoşbaş

    Uskudar University

    PRINCIPAL INVESTIGATOR
  • Berna Karamancıoglu

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 11, 2023

Study Start

July 1, 2022

Primary Completion

October 15, 2022

Study Completion

December 30, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations