자동 조정 동적 AFO 조사
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Katheryn Allyn, CPO, LPO
- 전화번호: 206-390-0228
연구 연락처 백업
- 이름: Joan Sanders, PhD
- 전화번호: 206-221-5872
- 이메일: jsanders@uw.edu
연구 장소
-
-
Washington
-
Seattle, Washington, 미국, 98105
- 모병
- University of Washington, Dept. of Bioengineering
-
연락하다:
- Joan Sanders, PhD
- 전화번호: 206-221-5872
- 이메일: jsanders@uw.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time Running Per Day
기간: Calculated across all days of data collection (up to 4 weeks).
|
Collected while participant uses device in free-living environment. |
Calculated across all days of data collection (up to 4 weeks).
|
|
Longest Running Bout Duration
기간: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
|
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).
|
|
PROMIS-Fatigue
기간: 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.
|
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.
|
|
Pain Score
기간: 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.
|
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.
|
|
Orthotic Evaluation Questionnaire (OEQ)
기간: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
|
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.
|
|
Running Speed on Treadmill
기간: In-lab testing will occur over the course of up to 2 hours at a time.
|
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.
|
|
Extended Figure-of-8 Test
기간: In-lab testing wil occur over the course of up to 2 hours at a time.
|
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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Joan E Sanders, PhD, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- STUDY00009120
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .