NCT06186284

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

December 15, 2023

Last Update Submit

March 4, 2026

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • PADUA score

    one month

  • cross-sectional area of median nerve on ultrasound

    one month

  • clinical provocative tests of the median nerve

    one month

  • Need for treatment of carpal tunnel syndrome

    one month

  • cross-sectional area of ulnar nerve on ultrasound

    one month

  • +1 more secondary outcomes

Study Arms (1)

patient

OTHER

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

Diagnostic Test: nerve conduction studyDiagnostic Test: ultrasonography wristsDiagnostic Test: Boston carpal tunnel questionnaireDiagnostic Test: clinical provocative tests for carpal tunnel syndrome

Interventions

nerve conduction studyDIAGNOSTIC_TEST

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

patient
ultrasonography wristsDIAGNOSTIC_TEST

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

patient
Boston carpal tunnel questionnaireDIAGNOSTIC_TEST

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

patient
clinical provocative tests for carpal tunnel syndromeDIAGNOSTIC_TEST

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

patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Valida

Brussels, 1082, Belgium

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian Neuropathy

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Guillaume Parein, MD

    Centre Hospitalier Valida

    PRINCIPAL INVESTIGATOR

  • Patricia Dessart, MD

    Centre Hospitalier Valida

    STUDY DIRECTOR

  • Samar M Hatem, MD,¨PhD

    Centre Hospitalier Valida

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 29, 2023

Study Start

December 1, 2023

Primary Completion

April 1, 2025

Study Completion

December 31, 2025

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)