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Completed

NCT Number: NCT06186284

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Valida

Brussels, 1082, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nerve Conduction Study

Diagnostic Test

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

ultrasonography wrists

Diagnostic Test

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

Boston carpal tunnel questionnaire

Diagnostic Test

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

clinical provocative tests for carpal tunnel syndrome

Diagnostic Test

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

Primary outcomes

  1. Boston Carpal Tunnel Questionnaire

    Time frame: 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 outcomes

  1. PADUA score

    Time frame: 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

  2. cross-sectional area of median nerve on ultrasound

    Time frame: one month

    Describes the diameter of the median nerve

  3. clinical provocative tests of the median nerve

    Time frame: one month

    Tinel and Phalen's sign

  4. Need for treatment of carpal tunnel syndrome

    Time frame: one month

    number of injections in the carpal tunnel/splinting of the wrist

  5. cross-sectional area of ulnar nerve on ultrasound

    Time frame: one month

    describes the diameter of the ulnar nerve

  6. amplitude of sensory nerve potential of the ulnar nerve

    Time frame: one month

    describes the functional status of the sensory ulnar nerve

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Valida

Other

Registry information

Official study title

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

Acronym: CRUTCH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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