Carpal Tunnel SyndromeCRUTCHNCT06186284
Impact of Walking Aids on the Occurrence of Carpal Tunnel Syndrome in Rehabilitation
A study testing nerve conduction study, ultrasonography wrists and Boston carpal tunnel questionnaire in people with Carpal Tunnel Syndrome, run by Centre Hospitalier Valida at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- nerve conduction study, ultrasonography wrists and Boston carpal tunnel questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- nerve conduction study, ultrasonography wrists, Boston carpal tunnel questionnaire, clinical provocative tests for carpal tunnel syndrome
- Keywords
- carpal tunnel
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve conduction studyDiagnostic test
sensory and motor nerve conduction study of both median nerves and ulnar nerves
ultrasonography wristsDiagnostic test
assess the cross-sectional area of the median nerves and the ulnar nerves
Boston carpal tunnel questionnaireDiagnostic test
assess the severity of symptoms and the functional impact related to carpal tunnel syndrome
clinical provocative tests for carpal tunnel syndromeDiagnostic test
Tinel and Phalen's test to evaluate the presence of carpal tunnel syndrome
| Study group | Role | What they receive |
|---|---|---|
| patient | Other | Rehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome Receives: Diagnostic Test: nerve conduction study; Diagnostic Test: ultrasonography wrists; Diagnostic Test: Boston carpal tunnel questionnaire; Diagnostic Test: clinical provocative tests for carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (6)
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
Measured: one month
cross-sectional area of median nerve on ultrasound
Describes the diameter of the median nerve
Measured: one month
clinical provocative tests of the median nerve
Tinel and Phalen's sign
Measured: one month
Need for treatment of carpal tunnel syndrome
number of injections in the carpal tunnel/splinting of the wrist
Measured: one month
cross-sectional area of ulnar nerve on ultrasound
describes the diameter of the ulnar nerve
Measured: one month
amplitude of sensory nerve potential of the ulnar nerve
describes the functional status of the sensory ulnar nerve
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Apr 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Valida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Parein, MD, Principal investigator, Centre Hospitalier ValidaPatricia Dessart, MD, Study director, Centre Hospitalier ValidaSamar M Hatem, MD,¨PhD, Study chair, Centre Hospitalier Valida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186284
- Sponsor's protocol ID
- 23-001
- Other IDs
- 2023/17JAN/025
- Acronym
- CRUTCH
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Technical Aids in the Occurrence of Carpal Tunnel Syndrome in Patients Undergoing Rehabilitation
- ClinicalTrials.gov ID
- NCT06186284
- Acronym / sponsor ID
- CRUTCH / 23-001
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier ValidaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| patient | Other | Diagnostic Test: nerve conduction study, Diagnostic Test: ultrasonography wrists, Diagnostic Test: Boston carpal tunnel questionnaire, Diagnostic Test: clinical provocative tests for carpal tunnel syndromeRehabilitation patients using a technical walking aid will be followed up for development of carpal tunnel syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nerve conduction studysensory and motor nerve conduction study of both median nerves and ulnar nerves | Diagnostic test | patient |
| ultrasonography wristsassess the cross-sectional area of the median nerves and the ulnar nerves | Diagnostic test | patient |
| Boston carpal tunnel questionnaireassess the severity of symptoms and the functional impact related to carpal tunnel syndrome | Diagnostic test | patient |
| clinical provocative tests for carpal tunnel syndromeTinel and Phalen's test to evaluate the presence of carpal tunnel syndrome | Diagnostic test | patient |
Primary outcome
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.
6 secondary outcomes
PADUA score
Time frame: one month
cross-sectional area of median nerve on ultrasound
Time frame: one month
clinical provocative tests of the median nerve
Time frame: one month
Need for treatment of carpal tunnel syndrome
Time frame: one month
cross-sectional area of ulnar nerve on ultrasound
Time frame: one month
amplitude of sensory nerve potential of the ulnar nerve
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Parein, MD principal investigator
Centre Hospitalier Valida
Patricia Dessart, MD study director
Centre Hospitalier Valida
Samar M Hatem, MD,¨PhD study chair
Centre Hospitalier Valida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve conduction study, ultrasonography wrists and Boston carpal tunnel questionnaire in people with Carpal Tunnel Syndrome, run by Centre Hospitalier Valida at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Questionnaire (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.