Effect of Ankle-foot Orthoses on Balance Confidence

NCT04080687 | Completed

• 1 other identifier: URIS201902
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ankle-foot orthoses; lower limbs; rehabilitation outpatients; balance confidence; falls

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 orthosis DEVICE

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

Fallers; Non-fallers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• insufficient cognitive ability to fill in the ABC Scale

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Poliomyelitis; Cerebral Palsy; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Brain Damage, Chronic; Brain Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Helena Burger, MD, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)