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

Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cerebral Palsy; Poliomyelitis; Peripheral Nerve Disease; Peripheral Nerve Injury Lower Limb
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: falls; lower limbs; balance confidence; ankle-foot orthoses; rehabilitation outpatients
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Brain Damage, Chronic; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Trauma, Nervous System; Spinal Cord Diseases; Myelitis; Multiple Sclerosis; Cerebral Palsy; Peripheral Nervous System Diseases; Nervous System Diseases; Poliomyelitis; Peripheral Nerve Injuries
• Other Study ID Numbers: URIS201902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No