Effect of Ankle-foot Orthoses on Balance Confidence

Multiple Sclerosis Clinical Trial

— ABCOGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080687
• Other study ID #: URIS201902
• Status: Completed
• Start date: February 6, 2020
• Est. completion date: February 12, 2021

Study information

• Verified date: February 2021
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Multiple Sclerosis
• Nervous System Diseases
• Peripheral Nerve Disease
• Peripheral Nerve Injuries
• Peripheral Nerve Injury Lower Limb
• Peripheral Nervous System Diseases
• Poliomyelitis

Intervention

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

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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