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

March 4, 2026 updated by: Centre Hospitalier Valida

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cross-sectional area of median nerve on ultrasound
Time Frame: one month
Describes the diameter of the median nerve
one month
clinical provocative tests of the median nerve
Time Frame: one month
Tinel and Phalen's sign
one month
Need for treatment of carpal tunnel syndrome
Time Frame: one month
number of injections in the carpal tunnel/splinting of the wrist
one month
cross-sectional area of ulnar nerve on ultrasound
Time Frame: one month
describes the diameter of the ulnar nerve
one month
amplitude of sensory nerve potential of the ulnar nerve
Time Frame: one month
describes the functional status of the sensory ulnar nerve
one month
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
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Valida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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