Impact of Walking Aids on the Occurrence of Carpal Tunnel Syndrome in Rehabilitation

NCT ID: NCT06186284

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to assess the impact of the use of technical walking aids in the adult population undergoing rehabilitation by evaluating clinical, electrophysiological, and iconographic parameters before and after the use of these devices.

Detailed Description

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The current evidence indicates that the short-term use of walking aids elicits pressure-induced anatomical changes of the median nerve and that long-term use of walking aids leads to a significant percentage of stroke patients developing clinical symptoms of carpal tunnel syndrome. We will investigate the consequences of using technical walking aids for gait in a broader population of rehabilitation patients. The rehabilitation setting per se may be considered a useful clinical 'human pathological model' for peripheral nerve entrapment. Recruited patients will be naïve to previous use of walking aids and de novo will start using them for gait rehabilitation, regardless of the underlying disease. This intervention model will allow us to identify clinical, electrophysiological, and anatomical changes of the median nerve due to the daily direct pressure elicited by walking aids. We consider that a one-month duration of use of walking aids is needed to observe detectable changes in electrophysiological and ultrasonographical assessment to elicit entrapment neuropathies in patients prone to developing them.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

cohort study
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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patient

Rehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome

Group Type OTHER

nerve conduction study

Intervention Type DIAGNOSTIC_TEST

sensory and motor nerve conduction study of both median nerves and ulnar nerves

ultrasonography wrists

Intervention Type DIAGNOSTIC_TEST

assess the cross-sectional area of the median nerves and the ulnar nerves

Boston carpal tunnel questionnaire

Intervention Type DIAGNOSTIC_TEST

assess the severity of symptoms and the functional impact related to carpal tunnel syndrome

clinical provocative tests for carpal tunnel syndrome

Intervention Type DIAGNOSTIC_TEST

Tinel and Phalen's test to evaluate the presence of carpal tunnel syndrome

Interventions

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nerve conduction study

sensory and motor nerve conduction study of both median nerves and ulnar nerves

Intervention Type DIAGNOSTIC_TEST

ultrasonography wrists

assess the cross-sectional area of the median nerves and the ulnar nerves

Intervention Type DIAGNOSTIC_TEST

Boston carpal tunnel questionnaire

assess the severity of symptoms and the functional impact related to carpal tunnel syndrome

Intervention Type DIAGNOSTIC_TEST

clinical provocative tests for carpal tunnel syndrome

Tinel and Phalen's test to evaluate the presence of carpal tunnel syndrome

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* admitted into an in-patient rehabilitation unit
* Functional Ambulation Category ≥ 1
* de novo need for a walking aid
* at least one functional upper limb
* expected duration of need for walking aid at least one month

Exclusion Criteria

* less than 18 years old
* current use of walking aid or use of a walking aid less than 6 months ago)
* difficulty filling out questionnaires or understanding instructions in French
* medical contraindications to the use of walking aids
* refusal to sign the consent form.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Valida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Parein, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Valida

Patricia Dessart, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Valida

Samar M Hatem, MD,¨PhD

Role: STUDY_CHAIR

Centre Hospitalier Valida

Locations

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Centre Hospitalier Valida

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Samar Hatem, MD,PhD

Role: CONTACT

+32 2 482 42 36

Patricia Dessart, MD

Role: CONTACT

+32 2 482 42 36

Facility Contacts

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Patricia Dessart, MD

Role: primary

+32 2 482 42 36

Other Identifiers

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2023/17JAN/025

Identifier Type: OTHER

Identifier Source: secondary_id

23-001

Identifier Type: -

Identifier Source: org_study_id

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