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Effect of Ankle-foot Orthoses on Balance Confidence

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04080687
Acronym
ABCOGS
Enrollment
150
Registered
2019-09-06
Start date
2020-02-06
Completion date
2021-02-12
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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

Sponsors

University Rehabilitation Institute, Republic of Slovenia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ABC ScaleAt day 0Activities-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.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026