NCT06048861

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

September 7, 2023

Last Update Submit

September 14, 2023

Conditions

Keywords

joint position senseelectrogoniometercarpal tunnel syndrome

Outcome Measures

Primary Outcomes (2)

  • Joint position sense

    The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®.

    Day 1

  • Joint position sense re-test

    The evaluation of participants' wrist position sense was performed with KForce Sens®.

    up to 1 week

Secondary Outcomes (1)

  • Function and symptom severity

    Day 1

Study Arms (2)

Individuals with Carpal Tunnel Syndrome

EXPERIMENTAL
Device: KForce SensDevice: Baseline Electrıgoniometer

Healthy Controls

EXPERIMENTAL
Device: KForce Sens

Interventions

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.

Healthy ControlsIndividuals with Carpal Tunnel Syndrome

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.

Individuals with Carpal Tunnel Syndrome

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 21, 2023

Study Start

February 20, 2022

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations