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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06048861
Other study ID # E-60116787-020-136447
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2022
Est. completion date April 4, 2023

Study information

Verified date September 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to investigate the validity and reliability of the KForce Sens® for the evaluation of wrist joint position sense in individuals with CTS. Wrist joint position sense was assessed with KForce Sens® and Baseline® electrogoniometer. The validity and reliability of the KForce Sens® for wrist position sense evaluation were investigated by comparing the two data sets.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 4, 2023
Est. primary completion date April 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 65 Years
Eligibility Inclusion Criteria: - mild to moderate CTS confirmed with EMG - having symptoms for at least 3 months - not receiving medical treatment and physiotherapy until 3 months before the study at the latest Exclusion Criteria: - having trauma in the affected extremity in the last 6 months - having cervical radiculopathy - having brachial plexopathy - having cognitive problems - having neurological problems - being pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Device:
KForce Sens
The device was attached to the middle of the wrist joint with the help of Velcro for all movements. Starting position of the extremity was determined and this position was introduced to the device as the reference position. Then, the participant was asked to perform the movement.
Baseline Electrigoniometer
The pivot point of the goniometer was placed next to the ulnar styloid for 30° and 60° wrist flexion and extension, and also it was placed in the middle carpometacarpal joint for radial and ulnar deviation. A passive movement was made to the extremity in a predetermined amount and direction. The participant was asked to remember this position. Then, the participant was asked to return the extremity to this position when their eyes were closed.

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Joint position sense The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®. Day 1
Primary Joint position sense re-test The evaluation of participants' wrist position sense was performed with KForce Sens®. up to 1 week
Secondary Function and symptom severity The Boston Carpal Tunnel Questionnaire included 19 items indicating the severity, frequency, and duration of symptoms and difficulty in performing daily tasks. Day 1
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