NCT04622657

Brief Summary

In order to achieve collaborative patient-centered rehabilitation in Parkinson's disease, detailed evaluation of walking and balance in evaluating the perceived difficulty in daily life is important to evaluate the progression of the disease and its response to treatments. In the literature, there are many scales that evaluate balance and functional performance in Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.

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 parkinson-disease

Timeline
Completed

Started Oct 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

October 25, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

October 29, 2020

Last Update Submit

April 9, 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).

    through study completion, an average of 1 year

  • 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.

    through study completion, an average of 1 year

  • 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

    through study completion, an average of 1 year

  • 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.

    through study completion, an average of 1 year

  • Funtional Reach Test

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

    through study completion, an average of 1 year

  • Berg Balance Test

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

    through study completion, an average of 1 year

Study Arms (1)

parkinson disease

EXPERIMENTAL

Assessment

Other: dubousset functional test

Interventions

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

parkinson disease

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with Parkinson's Disease (Hoehn Yahr level (1-3)
  • Volunteering to participate in research and approving the informed consent form Being over the age of 40
  • Using stable Parkinson's Disease medication for at least 4 weeks
  • No cooperation and communication problems

You may not qualify if:

  • Individuals with any other neurological and orthopedic problems Uncontrollable hypertension To your serious disk Significant comorbidity affecting balance and gait
  • Those with cooperation and communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Abit Kocaman

Kırıkkale, 7110, 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

Parkinson DiseaseGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşe Abit Kocaman, PhD

    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

October 29, 2020

First Posted

November 10, 2020

Study Start

October 25, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations