NCT06645054

Brief Summary

The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 24, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

October 11, 2024

Last Update Submit

March 24, 2025

Conditions

AmputationGait Disorders, Neurologic

Keywords

Gait analysisComputerised assessmentRehabilitationLower limb lossProsthetics and orthotics

Outcome Measures

Primary Outcomes (2)

  • Smart Hallway

    As part of the regular clinical examination, the patients walk straight through a 7m long walkway, turn, and come back while data is collected with the Smart Hallway system. They start walking one meter outside the capture volume. The procedure is repeated five times to provide a sufficient number of walking cycles. Three-dimensional temporospatial gait features (position, joint angles, velocities, accelerations) are extracted from the acquired data.

    Upon admission to rehabilitation

  • Falls during rehabilitation

    Data on falls during rehabilitation is routinely collected and entered in the hospital information system (HIS). It will be transferred from the HIS to the study database upon the patient's discharge.

    Upon discharge from rehabilitation

Secondary Outcomes (4)

  • World Health Organisation Disability Assessment Schedule

    Upon admission to rehabilitation

  • Activity Specific Balance Confidence Scale

    Upon admission to rehabilitation

  • Hospital Anxiety and Depression Scale

    Upon admission to rehabilitation

  • Six-minute walk test

    Upon admission to rehabilitation

Study Arms (2)

LLL

Rehabilitation patients with lower limb loss

Behavioral: Standard rehabilitationDevice: Lower-limb prosthesis

LLO

Rehabilitation patients fitted with a lower limb orthosis

Behavioral: Standard rehabilitationDevice: Lower-limb orthosis

Interventions

Standard rehabilitationBEHAVIORAL

The patients will receive standard rehabilitation that comprises assessment performed by a multidisciplinary team (physical-and-rehabilitation-medicine specialist physician, physiotherapist, occupational therapist, psychologist, social worker, prosthetics-and-orthotics engineer).

LLLLLO
Lower-limb prosthesisDEVICE

The patients from the LLL group will be fitted with an appropriate lower-limb prosthesis.

LLL
Lower-limb orthosisDEVICE

The patients from the LLO group will be fitted with an appropriate lower-limb orthosis.

LLO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after lower limb loss (because of traumatic reason or disease) for the LLL group; patients fitted with lower-limb orthosis because of neurological reasons for the LLO group

You may qualify if:

  • ability to walk at least 10 metres without help of a person,
  • no severe cognitive problems (able to answer questionnaires),
  • native Slovenian speakers,
  • wiling to participate (signed informed consent)

You may not qualify if:

  • severe cognitive impairment,
  • not being able to walk with or without a prosthesis or orthosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Interventions

Artificial Limbs

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesArtificial OrgansSurgical EquipmentOrthopedic Equipment

Study Officials

  • Helena Burger, MD, PhD

    University Rehabilitation Institute, Republic of Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Metka Moharić, MD, PhD

CONTACT

+386 1 4758441metka.moharic@ir-rs.si

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 16, 2024

Study Start

March 24, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

SL(1)