Peripheral Nerve DiseaseABCOGSNCT04080687
Effect of Ankle-foot Orthoses on Balance Confidence
An observational study of Peripheral Nerve Disease and Peripheral Nerve Injury Lower Limb, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Disease, Peripheral Nerve Injury Lower Limb, Poliomyelitis
- What is being tested?
- Ankle-foot orthosis
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 Feb 2020to 12 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients at our Prosthetics and Orthotics Outpatient Clinic having an ankle-foot orthosis for at least 1 year
Who cannot join
- insufficient cognitive ability to fill in the ABC Scale
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities
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.
Read the 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.
- Conditions
- Peripheral Nerve Disease, Peripheral Nerve Injury Lower Limb, Poliomyelitis, Cerebral Palsy, Multiple Sclerosis
- Being tested
- Ankle-foot orthosis
- Keywords
- ankle-foot orthoses, lower limbs, rehabilitation outpatients, balance confidence, falls
- Medical subject headings
- Peripheral Nervous System Diseases, Poliomyelitis, Cerebral Palsy, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-foot orthosisDevice
Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)
| Study group | Role | What they receive |
|---|---|---|
| Fallers | The patients who had fallen during the 6 months prior to the study onset Receives: Device: Ankle-foot orthosis | |
| Non-fallers | The patients who had not fallen during the 6 months prior to the study onset Receives: Device: Ankle-foot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start6 Feb 2020
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Burger, MD, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080687
- Sponsor's protocol ID
- URIS201902
- Acronym
- ABCOGS
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2019
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities
- ClinicalTrials.gov ID
- NCT04080687
- Acronym / sponsor ID
- ABCOGS / URIS201902
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallers | – | Device: Ankle-foot orthosisThe patients who had fallen during the 6 months prior to the study onset |
| Non-fallers | – | Device: Ankle-foot orthosisThe patients who had not fallen during the 6 months prior to the study onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients at our Prosthetics and Orthotics Outpatient Clinic having an ankle-foot orthosis for at least 1 year
Key exclusion criteria (1 listed)
- insufficient cognitive ability to fill in the ABC Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle-foot orthosisAnkle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction) | Device | Fallers, Non-fallers |
Primary outcome
ABC Scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Burger, MD, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Disease and Peripheral Nerve Injury Lower Limb, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABC Scale (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.