Back to resultsEvaluation of Joint Position Sense in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
KForce Sens
Baseline Electrıgoniometer
Sponsored by
About this trial
This is an interventional diagnostic trial for Carpal Tunnel Syndrome focused on measuring joint position sense, electrogoniometer, carpal tunnel syndrome
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Individuals with Carpal Tunnel Syndrome
Healthy Controls
Arm Description
Outcomes
Primary Outcome Measures
Joint position sense
The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®.
Joint position sense re-test
The evaluation of participants' wrist position sense was performed with KForce Sens®.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06048861
First Posted
September 7, 2023
Last Updated
September 14, 2023
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT06048861
Brief Title
Evaluation of Joint Position Sense in Carpal Tunnel Syndrome
Official Title
Evaluation of Joint Position Sense With Two Different Electrogoniometers in Mild and Moderate Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
joint position sense, electrogoniometer, carpal tunnel syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individuals with Carpal Tunnel Syndrome
Arm Type
Experimental
Arm Title
Healthy Controls
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
KForce Sens
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Baseline Electrıgoniometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Joint position sense
Description
The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®.
Time Frame
Day 1
Title
Joint position sense re-test
Description
The evaluation of participants' wrist position sense was performed with KForce Sens®.
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Function and symptom severity
Description
The Boston Carpal Tunnel Questionnaire included 19 items indicating the severity, frequency, and duration of symptoms and difficulty in performing daily tasks.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Joint Position Sense in Carpal Tunnel Syndrome
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