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Evaluation of Joint Position Sense in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT06048861
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Sinem Yenil, PT, MSc, Pamukkale University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 20, 2022
Actual Primary Completion Date : April 4, 2023
Actual Study Completion Date : April 4, 2023

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Joint position sense [ Time Frame: Day 1 ]
    The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®.

  2. Joint position sense re-test [ Time Frame: up to 1 week ]
    The evaluation of participants' wrist position sense was performed with KForce Sens®.


Secondary Outcome Measures :
  1. Function and symptom severity [ Time Frame: 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
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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048861


Locations
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Turkey
Pamukkale University
Denizli, Turkey
Sponsors and Collaborators
Pamukkale University
More Information
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Responsible Party: Sinem Yenil, PT, MSc, Research Assistant, Pamukkale University
ClinicalTrials.gov Identifier: NCT06048861    
Other Study ID Numbers: E-60116787-020-136447
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinem Yenil, PT, MSc, Pamukkale University:
joint position sense
electrogoniometer
carpal tunnel syndrome
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries