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

Carpal Tunnel Syndrome Clinical Trial

— CRUTCH  

Official title:

Impact of Technical Aids in the Occurrence of Carpal Tunnel Syndrome in Patients Undergoing Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186284
• Other study ID #: 23-001
• Secondary ID: 2023/17JAN/025
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Valida
• Contact: Samar Hatem, MD,PhD
• Phone: +32 2 482 42 36
• Email: samar.hatem[@]valisana.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• nerve conduction study
sensory and motor nerve conduction study of both median nerves and ulnar nerves
• ultrasonography wrists
assess the cross-sectional area of the median nerves and the ulnar nerves
• Boston carpal tunnel questionnaire
assess the severity of symptoms and the functional impact related to carpal tunnel syndrome
• clinical provocative tests for carpal tunnel syndrome
Tinel and Phalen's test to evaluate the presence of carpal tunnel syndrome

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Valida	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Valida

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Questionnaire	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.	one month
Secondary	PADUA score	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	one month
Secondary	cross-sectional area of median nerve on ultrasound	Describes the diameter of the median nerve	one month
Secondary	clinical provocative tests of the median nerve	Tinel and Phalen's sign	one month
Secondary	Need for treatment of carpal tunnel syndrome	number of injections in the carpal tunnel/splinting of the wrist	one month
Secondary	cross-sectional area of ulnar nerve on ultrasound	describes the diameter of the ulnar nerve	one month
Secondary	amplitude of sensory nerve potential of the ulnar nerve	describes the functional status of the sensory ulnar nerve	one month