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

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Diagnostic test: nerve conduction study; Diagnostic test: ultrasonography wrists; Diagnostic test: Boston carpal tunnel questionnaire; Diagnostic test: clinical provocative tests for carpal tunnel syndrome

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1082
    • Centre Hospitalier Valida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cross-sectional area of median nerve on ultrasound	Describes the diameter of the median nerve	one month
clinical provocative tests of the median nerve	Tinel and Phalen's sign	one month
Need for treatment of carpal tunnel syndrome	number of injections in the carpal tunnel/splinting of the wrist	one month
cross-sectional area of ulnar nerve on ultrasound	describes the diameter of the ulnar nerve	one month
amplitude of sensory nerve potential of the ulnar nerve	describes the functional status of the sensory ulnar nerve	one month
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Valida
• Investigators: Principal Investigator: Guillaume Parein, MD, Centre Hospitalier Valida; Study Director: Patricia Dessart, MD, Centre Hospitalier Valida; Study Chair: Samar M Hatem, MD,¨PhD, Centre Hospitalier Valida

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: carpal tunnel
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Median Neuropathy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis; Nerve Conduction Studies
• Other Study ID Numbers: 23-001; 2023/17JAN/025 (Other Identifier: Comité d'éthique hospitalo-facultaire Saint-Luc -UCLouvain)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No