NCT04627558

Brief Summary

Increased muscle tone, decreased normal range of motion, and functional impairments may result in decreased load on the affected limb, deviations in gait patterns, balance and coordination disorders in individuals with stroke. In the literature, there are many scales that evaluate balance and functional performance in stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

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

November 6, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

November 8, 2020

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Dubousset Function Test

    The four components of the DFT included (1) the Up Walking Test: participants rose without assistance from a and seated position in a chair that did not have arms, walked 5 meters (500 cm) forward before stopping, walked backwards 5 meters, and sat again without assistance; (2) the Steps Test: from a starting position 50 cm away, volunteers climbed three stairs, turned around on the third step (top), and walked down the three steps; (3) Down and Sitting Test: from a standing position, participants sat on the ground and stood up again, using assistance as needed; (4) Dual-Tasking Test: participants walked 5 meters forward, turned around, and walked 5 meters back to the starting position while performing a working memory test (counting down from 50 by intervals of 2).

    First 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

  • 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

  • Tinetti Balance and Gait Test

    In the test used to evaluate balance, walking score is maximum 12 points, balance score is maximum 16 points and a total of 28 points.

    first day

  • Berg Balance Test

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

    first day

  • Funtional 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, balance assessment

Dubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test

Other: stroke patients, balance assessment

Interventions

validity relability dubousset functional test

stroke patients, balance assessment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

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)

Yusuf Emre Bozkurt

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (1)

  • Diebo BG, Challier V, Shah NV, Kim D, Murray DP, Kelly JJ, Lafage R, Paulino CB, Passias PG, Schwab FJ, Lafage V. The Dubousset Functional Test is a Novel Assessment of Physical Function and Balance. Clin Orthop Relat Res. 2019 Oct;477(10):2307-2315. doi: 10.1097/CORR.0000000000000820.

    PMID: 31135543BACKGROUND

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

  • Yusuf Emre Bozkurt, PT

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2020

First Posted

November 13, 2020

Study Start

November 6, 2020

Primary Completion

February 1, 2022

Study Completion

February 15, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations