NCT04229914

Brief Summary

The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. Reliability is extremely important, especially for research and clinical applications. In order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. However, there are no studies investigating the validity and reliability of this test in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

January 1, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

January 1, 2020

Last Update Submit

November 20, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 3-m backwards walk test,

    A distance of 3 m is measured and marked with black tape. Individuals are asked to follow the heel and black band. With the 'start' command they are asked to walk backwards quickly. When the distance of 3 m is completed, a stop is instructed. Individuals are not allowed to run during the test. They are allowed to look back if they wish. The assessor walks behind individuals throughout the test. The test is repeated 3 times, the averages are recorded

    first day and second day

  • timed up and go test

    A standard chair is used for testing. First, the patient is asked to sit on the chair. The patient is then asked to stand up and walk regularly at a distance of 3 meters with a predetermined length, then return to the chair after 3 meters.

    first day

  • 10 m walking test

    In this test, the individual is asked to walk at his / her normal speed within a pre-measured 10-meter area and is started when the individual is at the starting line of the foot and terminated when he crosses the finish line.

    first day

  • Berg balance test

    The BBS consists of 14 items to directly monitor the maintenance of body balance during performance.

    first day

  • Functional reach test

    It is used to measure both the balance of the individual functionally and the amount of dynamic reach.

    first day

Study Arms (1)

stroke patients

OTHER

Assessment

Other: stroke patinets

Interventions

3-m backwards walk test, timed up and go test, 10 m walk test, Berg BalanceTest, Functional Reach Test

stroke patients

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older,
  • Getting a diagnosis of stroke,
  • Not having cooperation and communication problems
  • To be able to walk 10 m independently with or without device

You may not qualify if:

  • Have a neurological or orthopedic problem other than stroke that will affect functionality and balance
  • Individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Abit Kocaman

Kırıkkale, 7110, Turkey (Türkiye)

Location

Related Publications (1)

  • Carter V, Jain T, James J, Cornwall M, Aldrich A, de Heer HD. The 3-m Backwards Walk and Retrospective Falls: Diagnostic Accuracy of a Novel Clinical Measure. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):249-255. doi: 10.1519/JPT.0000000000000149.

    PMID: 29095771BACKGROUND

MeSH Terms

Conditions

StrokeMobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşe A Abit Kocaman

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 1, 2020

First Posted

January 18, 2020

Study Start

January 10, 2020

Primary Completion

August 30, 2020

Study Completion

September 11, 2020

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations