Evaluation of Joint Position Sense in Carpal Tunnel Syndrome

Sponsor

Pamukkale University (Other)

Overall Status

Completed

CT.gov ID

NCT06048861

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Device: KForce Sens Device: Baseline Electrıgoniometer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Joint Position Sense With Two Different Electrogoniometers in Mild and Moderate Carpal Tunnel Syndrome

Actual Study Start Date :

Feb 20, 2022

Actual Primary Completion Date :

Apr 4, 2023

Actual Study Completion Date :

Apr 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Individuals with Carpal Tunnel Syndrome	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. Device: Baseline Electrıgoniometer 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.
Experimental: Healthy Controls	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.

Arm

Intervention/Treatment

Experimental: Individuals with Carpal Tunnel Syndrome

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.

Device: Baseline Electrıgoniometer

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.

Experimental: Healthy Controls

Device: KForce Sens

Outcome Measures

Primary Outcome Measures

Joint position sense [Day 1]
The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®.
Joint position sense re-test [up to 1 week]
The evaluation of participants' wrist position sense was performed with KForce Sens®.

Secondary Outcome Measures

Function and symptom severity [Day 1]
The Boston Carpal Tunnel Questionnaire included 19 items indicating the severity, frequency, and duration of symptoms and difficulty in performing daily tasks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli		Turkey

Sponsors and Collaborators

Pamukkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sinem Yenil, PT, MSc, Research Assistant, Pamukkale University

ClinicalTrials.gov Identifier:

NCT06048861

Other Study ID Numbers:

E-60116787-020-136447

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sinem Yenil, PT, MSc, Research Assistant, Pamukkale University

joint position sense

electrogoniometer

carpal tunnel syndrome

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Syndrome

Study Results

No Results Posted as of Sep 21, 2023