NCT04627259

Brief Summary

Purpose of the study is the validity and reliability of the Turkish version of The Thumb Disability Examination (TDX) so that it would be used as an assessment tool for Turkish thumb patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 10, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

November 9, 2020

Last Update Submit

April 26, 2021

Conditions

Keywords

thumbthumb painthumb functionquestionnaireexaminationvalidationcultural adaptation

Outcome Measures

Primary Outcomes (2)

  • Thumb Disability Examination (TDX)

    TDX is a 20-question survey divided into 3 sections. It can be calculated as a whole or for each section alone. All scoring is done on a 0-100 scale, with 0 being the least and 100 the most disability.

    Baseline- 3 days later

  • Visüel Analog Scale- Pain

    The severity of the pain felt by individuals during the activity that they have difficulty will be evaluated using the Visual Analogue Scale (VAS).

    Baseline

Secondary Outcomes (1)

  • The Disabilities of the Arm, Shoulder and Hand (DASH)

    Baseline- 3 days later

Other Outcomes (2)

  • Michigan Hand Outcomes Questionnaire

    Baseline

  • Short Form-36

    Baseline

Study Arms (1)

patient

patients with thumb pain or functional problems

Other: Thumb Disability Examination

Interventions

Turkish Version of Thumb Disability Examination. The Turkish Version of Thumb Disability Examination consists of 20 questions related with thumb pain and functionality.

patient

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Voluntary patients who applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery and Rehabilitation Unit within the last 6 months, with a history of TMC OA, De Quervain, trigger finger, fracture involving the thumb bones, ligament and tendon injuries, will be included in the study.

You may qualify if:

  • able to speak, read, understand and write in Turkish
  • having thumb pain
  • being over the age of 18

You may not qualify if:

  • mental disorders
  • cognitive limitations
  • able not to speak, read, understand and write in Turkish
  • out of age 18-80 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Physiotherapy and Rehabilitation Faculty, Hand Surgery Rehabilitation Unit

Altındağ, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

  • Noback PC, Lombardi JM, Seetharaman M, Lee DH, Strauch RJ, Rosenwasser MP. Development and Validation of a Disease-Specific Questionnaire for Basal Joint Arthritis. J Wrist Surg. 2017 May;6(2):126-133. doi: 10.1055/s-0036-1593612. Epub 2016 Oct 14.

    PMID: 28428914BACKGROUND
  • Düger T, Yakut E, Öksüz Ç, et al. Kol, Omuz, El Sorunları (Disabilities of the Arm, Shoulder and Hand-DASH) Anketi Türkçe uyarlamasının güvenirliği ve geçerliği. Fizyoter Rehabil. 2006;17:99-107.

    BACKGROUND
  • Oksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.

    PMID: 21295925BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asssistant

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 13, 2020

Study Start

December 10, 2018

Primary Completion

June 10, 2021

Study Completion

July 10, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations