Clinical trial NCT06186284: Impact of Walking Aids on the Occurrence of Carpal Tunnel Syndrome in Rehabilitation
Official title: Impact of Technical Aids in the Occurrence of Carpal Tunnel Syndrome in Patients Undergoing Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel
Lead sponsor: Centre Hospitalier Valida
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cohort study
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: one month
Secondary outcomes:
measure: PADUA score
timeFrame: one month
measure: cross-sectional area of median nerve on ultrasound
timeFrame: one month
measure: clinical provocative tests of the median nerve
timeFrame: one month
measure: Need for treatment of carpal tunnel syndrome
timeFrame: one month
measure: cross-sectional area of ulnar nerve on ultrasound
timeFrame: one month
measure: amplitude of sensory nerve potential of the ulnar nerve
timeFrame: one month
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre Hospitalier Valida
Study officials:
affiliation: Centre Hospitalier Valida
name: Guillaume Parein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Valida
name: Patricia Dessart, MD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Valida
name: Samar M Hatem, MD,¨PhD
role: STUDY_CHAIR
References: