Trials Sponsors Conditions Drugs Pricing

Conditions

Cerebral Palsy Multiple Sclerosis Peripheral Nerve Disease Peripheral Nerve Injury Lower Limb Poliomyelitis

Keywords

ankle-foot orthoseslower limbsrehabilitation outpatientsbalance confidencefalls

Outcome Measures

Primary Outcomes (1)

ABC Scale
Activities-Specific Balance Confidence Scale (ABC Scale) will be filled in for the confidence without the orthosis and confidence with the orthosis. The ABC Scale is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Each item is rated on a scale from 0 (no confidence) to 100 (complete confidence). Overall score is the average rating across the items.
At day 0

Study Arms (2)

Fallers

The patients who had fallen during the 6 months prior to the study onset

Device: Ankle-foot orthosis

Non-fallers

The patients who had not fallen during the 6 months prior to the study onset

Device: Ankle-foot orthosis

Interventions

Ankle-foot orthosisDevice

Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)

FallersNon-fallers

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

All the patients of our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least 1 year and able to fill in the ABC Scale

You may qualify if:

patients at our Prosthetics and Orthotics Outpatient Clinic having an ankle-foot orthosis for at least 1 year

Sponsors & Collaborators

University Rehabilitation Institute, Republic of Slovenia
Otherlead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

MeSH Terms

Conditions

Peripheral Nervous System DiseasesPoliomyelitisCerebral PalsyMultiple Sclerosis

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesSpinal Cord Diseases

Study Officials

Helena Burger, MD, PhD
University Rehabilitation Institute, Republic of Slovenia
PRINCIPAL INVESTIGATOR

Enrollment

150 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 6, 2019

Study Start

February 6, 2020

Actual (reported)

Effect of Ankle-foot Orthoses on Balance Confidence

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Fallers

Non-fallers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Fallers

Non-fallers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations