Trials Sponsors Conditions Drugs Pricing

Conditions

Amputation Gait 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.

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,

Sponsors & Collaborators

University Rehabilitation Institute, Republic of Slovenia
Otherlead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

Helena Burger, MD, PhDCONTACT+386 1 4758443 helena.burger@ir-rs.si

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 4758441 metka.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

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Usability of the Smart Hallway System in Clinical Setting

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

LLL

LLO

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

LLL

LLO

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations