Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Ankle-foot Orthoses on Balance Confidence (ABCOGS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080687
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Rehabilitation Institute, Republic of Slovenia

Brief Summary:
The patients at our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least one year will fill in the Activities-Specific Balance Confidence Scale (ABC Scale) for wearing the orthosis and for not wearing the orthosis. They will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.

Condition or disease Intervention/treatment
Peripheral Nerve Disease Peripheral Nerve Injury Lower Limb Poliomyelitis Cerebral Palsy Multiple Sclerosis Device: Ankle-foot orthosis

Detailed Description:
The effect of the orthosis will be estimated as the difference between the two ABC Scale scores. The ABC Scale score and individual items will be compared between the fallers and the non-fallers.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Group/Cohort Intervention/treatment
Fallers
The patients who had fallen during the 6 months prior to the study onset
Device: Ankle-foot orthosis
Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)

Non-fallers
The patients who had not fallen during the 6 months prior to the study onset
Device: Ankle-foot orthosis
Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)




Primary Outcome Measures :
  1. ABC Scale [ Time Frame: At day 0 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • insufficient cognitive ability to fill in the ABC Scale

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080687


Contacts
Layout table for location contacts
Contact: Helena Burger, MD, PhD +386 1 4758441 helena.burger@ir-rs.si

Locations
Layout table for location information
Slovenia
University Rehabilitation Institute, Republic of Slovenia Recruiting
Ljubljana, Slovenia, 1000
Contact: Helena Burger, MD, PhD    +386 1 4758440    helena.burger@ir-rs.si   
Sponsors and Collaborators
University Rehabilitation Institute, Republic of Slovenia
Investigators
Layout table for investigator information
Principal Investigator: Helena Burger, MD, PhD University Rehabilitation Institute, Republic of Slovenia
Layout table for additonal information
Responsible Party: University Rehabilitation Institute, Republic of Slovenia
ClinicalTrials.gov Identifier: NCT04080687    
Other Study ID Numbers: URIS201902
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Rehabilitation Institute, Republic of Slovenia:
ankle-foot orthoses
lower limbs
rehabilitation outpatients
balance confidence
falls
Additional relevant MeSH terms:
Layout table for MeSH terms
Poliomyelitis
Multiple Sclerosis
Cerebral Palsy
Peripheral Nerve Injuries
Nervous System Diseases
Peripheral Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Spinal Cord Diseases
Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries