Onderzoek naar automatische aanpassing van dynamische AFO
Offloading Ankle Foot Orthoses (AFOs) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. While they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. This study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Katheryn Allyn, CPO, LPO
- Telefoonnummer: 206-390-0228
Studie Contact Back-up
- Naam: Joan Sanders, PhD
- Telefoonnummer: 206-221-5872
- E-mail: jsanders@uw.edu
Studie Locaties
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Washington
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Seattle, Washington, Verenigde Staten, 98105
- Werving
- University of Washington, Dept. of Bioengineering
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Contact:
- Joan Sanders, PhD
- Telefoonnummer: 206-221-5872
- E-mail: jsanders@uw.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria (Healthy Volunteers):
-able to run continuously for 1 minute
Inclusion Criteria (All Other Volunteers)
- prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
- Use prescribed offloading AFO at least 20 hours per week
- Prescribed AFO strut length of at least 200 mm
- Able to run continuously for 1 minute
Exclusion Criteria (Healthy Volunteers):
- limited sensation in the lower limbs
- use an assistive device
Exclusion Criteria (All Other Volunteers):
- Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
- Unable to sit, stand, or negotiate a step onto lab treadmill
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Aim 2
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device. |
The Dynamic AFO is able to adjust in stiffness depending on activity. |
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Experimenteel: Aim 3
Participants will be asked to take the Dynamic AFO home and wear the device for up to 4 weeks. The device will be set in either an adjustment-capable mode, or a "locked" mode that functions similar to their own orthotic--the order in which they are tested will be randomized. |
The Dynamic AFO is able to adjust in stiffness depending on activity. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time Running Per Day
Tijdsspanne: Calculated across all days of data collection (up to 4 weeks).
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Collected while participant uses device in free-living environment. |
Calculated across all days of data collection (up to 4 weeks).
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Longest Running Bout Duration
Tijdsspanne: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
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Collected while participant uses device in free-living environment. |
Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
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PROMIS-Fatigue
Tijdsspanne: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to fatigue.
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Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating a greater level of fatigue. |
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to fatigue.
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Pain Score
Tijdsspanne: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to pain.
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Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each Pain-Score question asks participants to rank on a scale from 1 to 10 (categorical options), with higher scores indicating a greater level of pain. |
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to pain.
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Orthotic Evaluation Questionnaire (OEQ)
Tijdsspanne: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
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Similar to the Prosthesis Evaluation Questionnaire (PEQ), the OEQ will ask various questions concerning their experience wearing the variable stiffness AFO. Participants will rate their overall satisfaction, ability to ambulate, the health of their limb, the utility of the device, and their overall well-being after wearing the device. |
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
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Running Speed on Treadmill
Tijdsspanne: In-lab testing will occur over the course of up to 2 hours at a time.
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Participants carrying out the in-lab protocol will be asked to run using the variable stiffness AFO and running speed will be documented at various time points. |
In-lab testing will occur over the course of up to 2 hours at a time.
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Extended Figure-of-8 Test
Tijdsspanne: In-lab testing wil occur over the course of up to 2 hours at a time.
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Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test. |
In-lab testing wil occur over the course of up to 2 hours at a time.
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Joan E Sanders, PhD, University of Washington
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- STUDY00009120
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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