Ankle-foot Orthoses for Peripheral Artery Disease
9 luglio 2019 aggiornato da: University of Minnesota
Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I
The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO.
Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes.
We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
31
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Montana
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Missoula, Montana, Stati Uniti, 59802
- International Heart Institute of Montana Foundation
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
40 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD).
- Patients who experience calf claudication
- ≥40 years of age
- An abnormal ankle-brachial index (ABI) of ≤.90.
- For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
Exclusion Criteria:
- Lower extremity amputation(s) which interfere(s) with walking.
- Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities).
- Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis)
- Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening.
- Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure.
- Myocardial infarction within 3 months prior to screening.
- Acute coronary syndrome symptoms diagnosed at time of screening.
- Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and >1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm).
- Transient ischemic attack or stroke 3 months prior to screening.
- New left bundle branch block or sustained ventricular tachycardia >30 seconds during screening.
- Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening.
- Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening.
- Individuals currently incarcerated.
- Evidence of acute impairment from alcohol or other illicit drugs.
- Lack of diabetes control (glycated hemoglobin >12%)
- Patients who are anemic (Hgb <11 g/dL for women and <10 g/dL for men).
- Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: AFO to improve outcomes
Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum
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Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation.
The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.
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Nessun intervento: Historical Controls
Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in WIQ Distance Subscore
Lasso di tempo: 12 weeks
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In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty.
The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs.
The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
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12 weeks
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Change in WIQ Speed Subscore
Lasso di tempo: 12 weeks
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In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty.
The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs.
The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
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12 weeks
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Change in WIQ Stair-Climbing Subscore
Lasso di tempo: 12 weeks
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In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty.
The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs.
The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
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12 weeks
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Change in SF-36 PCS
Lasso di tempo: 12 weeks
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Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health).
These subscores are weighted sums of the questions in each section.
Scores range from 0 - 100.
Lower scores = more disability, higher scores = less disability.
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12 weeks
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Change in SF-36 MCS
Lasso di tempo: 12 weeks
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Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health).
These subscores are weighted sums of the questions in each section.
Scores range from 0 - 100.
Lower scores = more disability, higher scores = less disability.
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12 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ryan J. Mays, PhD, MPH, MS, International Heart Institute of Montana Foundation
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2014
Completamento primario (Effettivo)
1 dicembre 2017
Completamento dello studio (Effettivo)
1 dicembre 2017
Date di iscrizione allo studio
Primo inviato
28 ottobre 2014
Primo inviato che soddisfa i criteri di controllo qualità
28 ottobre 2014
Primo Inserito (Stima)
31 ottobre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
31 luglio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 luglio 2019
Ultimo verificato
1 luglio 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Mays-2
- U54GM104944 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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