Effect of Ankle-foot Orthoses on Balance Confidence

NCT ID: NCT04080687

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-06

Study Completion Date

2021-02-12

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fallers

The patients who had fallen during the 6 months prior to the study onset

Ankle-foot orthosis

Intervention Type DEVICE

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

Ankle-foot orthosis

Intervention Type DEVICE

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

Interventions

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Ankle-foot orthosis

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helena Burger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rehabilitation Institute, Republic of Slovenia

Locations

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University Rehabilitation Institute, Republic of Slovenia

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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URIS201902

Identifier Type: -

Identifier Source: org_study_id

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