Effect of Ankle-foot Orthoses on Balance Confidence

Completed

• Conditions: Peripheral Nerve Disease; Peripheral Nerve Injury Lower Limb; Cerebral Palsy; Poliomyelitis; Multiple Sclerosis
• Interventions: Device: Ankle-foot orthosis

• Registration Number: NCT04080687
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-06
• Study Start: 2020-02-06
• Status Verified: 2021-02
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-12
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-fallers	Ankle-foot orthosis	The patients who had not fallen during the 6 months prior to the study onset
Fallers	Ankle-foot orthosis	The patients who had fallen during the 6 months prior to the study onset

Primary Outcome Measures

Name	Time	Method
ABC Scale	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.

Trial Locations

Locations (1)

University Rehabilitation Institute, Republic of Slovenia; 🇸🇮 Ljubljana, Slovenia