Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Evaluating Functional Outcomes and Clinical Feasibility of the Zeen Mobility Device in Outpatient Rehabilitation
The goal of this clinical trial is to learn whether the Zeen Mobility Device can improve mobility and function during outpatient rehabilitation for adults with mobility impairments. The study will also evaluate the safety of the device and how easy it is for participants and therapists to use during routine therapy.
The main questions it aims to answer are:
- Does using the Zeen Mobility Device improve walking, standing, transfers, and daily function compared with a participant's usual mobility device?
- Can the Zeen Mobility Device be safely incorporated into outpatient rehabilitation?
- How satisfied are participants and therapists with using the device during therapy?
Researchers will compare participants' performance using the Zeen Mobility Device with their performance using their usual mobility device, such as a walker or wheelchair. Participants will serve as their own comparison group.
Participants will:
- Complete a baseline assessment before starting the study, a midpoint assessment after 4 treatment sessions, and a final assessment after 8 treatment sessions.
- Attend 8 outpatient physical therapy sessions that include use of the Zeen Mobility Device.
- Use the Zeen Mobility Device for at least 15 minutes during each study visit for balance, mobility, walking, transfer, or standing activities selected by their therapist.
- Complete mobility and functional tests using both the Zeen Mobility Device and their usual mobility device at each assessment visit.
- Provide feedback about their experience using the device while researchers monitor safety and any device-related problems.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: George Kopiloff
- 전화번호: 3500 909-596-7733
- 이메일: GKopiloff@casacolina.org
연구 장소
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California
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Pomona, California, 미국, 91767
- Casa Colina Hospital and Centers for Healthcare
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연락하다:
- George Kopiloff
- 전화번호: 3500 909-596-7733
- 이메일: gkopiloff@casacolina.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Be 18 years of age or older
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Be enrolled in outpatient PT and/or OT
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Demonstrate mobility limitations appropriate for Zeen use
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Meet the following functional thresholds:
- 6MWT: 800-1800 feet
- 10MWT: 0.4-1.3 m/s
- Grip strength ≥1 pound in at least one hand
- Knee extension strength ≥ MMT grade 3/5
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Be capable of providing informed consent
Exclusion Criteria:
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Zeen Intervention Group
|
Participants will:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Timed Up and Go
기간: Baseline, 2 weeks, and 4 weeks
|
The Timed Up and Go Test is a clinical tool used to evaluate functional mobility, balance, walking ability, and fall risk in older adults and individuals with neurological or musculoskeletal conditions. Scoring is measured in seconds to complete the task. Higher scores indicate worse mobility, balance, and walking ability. |
Baseline, 2 weeks, and 4 weeks
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10 Meter Walk Test
기간: Baseline, 2 weeks, and 4 weeks
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The 10 Meter Walk Test is an assessment of a person's walking speed as they walk 10 meters, measured in seconds. A higher score indicates worsening balance and walking capacity, and is associated with poorer home and community access and increased fall risk |
Baseline, 2 weeks, and 4 weeks
|
|
6 Minute Walk Test
기간: Baseline, 2 weeks, and 4 weeks
|
The 6 Minute Walk Test is an assessment of a person's walking endurance as they walk during a 6-minute period, measured in total distance walked in meters. A higher score is associated with better walking endurance and capacity, and is associated with better home and community access and decreased fall risk |
Baseline, 2 weeks, and 4 weeks
|
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Barthel Index
기간: Baseline, 2 weeks, and 4 weeks
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The Barthel Index is an ordinal clinical scale that measures a patient's level of functional independence in 10 basic activities of daily living and mobility. The scale calculates 10 items into a point total, from 0 to 100, with a higher score indicating a greater level of independence and decreased need for nursing and caregiver support. |
Baseline, 2 weeks, and 4 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Satisfaction and Exertion Survey
기간: Baseline, 2 weeks, and 4 weeks
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Participants will report satisfaction with the device on a 5-point Likert Scale, or a 10-point scale, including:
Total scores range from 9 to 50, with a higher score indicating more difficulty with the device, and decreased satisfaction. |
Baseline, 2 weeks, and 4 weeks
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ZeenMobility
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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