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

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: nerve conduction study; Diagnostic Test: ultrasonography wrists; Diagnostic Test: Boston carpal tunnel questionnaire; Diagnostic Test: clinical provocative tests for carpal tunnel syndrome

• Registration Number: NCT06186284
• Lead Sponsor: Centre Hospitalier Valida

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.

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient	nerve conduction study	Rehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome
patient	Boston carpal tunnel questionnaire	Rehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome
patient	ultrasonography wrists	Rehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome
patient	clinical provocative tests for carpal tunnel syndrome	Rehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire	one month	The Boston Carpal Tunnel Questionnaire comprises two separate scales: the Symptom Severity Scale (SSS), which consists of 11 questions, and the Functional Status Scale (FSS), which consists of 8 items and requires respondents to score the difficulty of each item on a five-point scale. A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.

Secondary Outcome Measures

Name	Time	Method
PADUA score	one month	The PADUA score is a classification of the neurophysiological severity of median neuropathy across the wrist. It is scored in 6 classes (1 to 6) with a higher score indicating greater neurophysiological damage to the median nerve
cross-sectional area of median nerve on ultrasound	one month	Describes the diameter of the median nerve
clinical provocative tests of the median nerve	one month	Tinel and Phalen's sign
cross-sectional area of ulnar nerve on ultrasound	one month	describes the diameter of the ulnar nerve
Need for treatment of carpal tunnel syndrome	one month	number of injections in the carpal tunnel/splinting of the wrist
amplitude of sensory nerve potential of the ulnar nerve	one month	describes the functional status of the sensory ulnar nerve

Trial Locations

Locations (1)

Centre Hospitalier Valida; 🇧🇪 Brussels, Belgium