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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：George Kopiloff
- 電話番号：3500 909-596-7733
- メール：GKopiloff@casacolina.org
研究場所
-
-
California
-
Pomona、California、アメリカ、91767
- Casa Colina Hospital and Centers for Healthcare
-
コンタクト：
- George Kopiloff
- 電話番号：3500 909-596-7733
- メール：gkopiloff@casacolina.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Be 18 years of age or older
-
Be enrolled in outpatient PT and/or OT
-
Demonstrate mobility limitations appropriate for Zeen use
-
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
-
Be capable of providing informed consent
Exclusion Criteria:
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Zeen Intervention Group
|
Participants will:
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Timed Up and Go
時間枠：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
|
|
10 Meter Walk Test
時間枠：Baseline, 2 weeks, and 4 weeks
|
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
時間枠：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
|
|
Barthel Index
時間枠：Baseline, 2 weeks, and 4 weeks
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Satisfaction and Exertion Survey
時間枠：Baseline, 2 weeks, and 4 weeks
|
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
|
協力者と研究者
捜査官
- スタディディレクター：Emily Rosario, PhD、Casa Colina Hospital and Centers for Healthcare
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ZeenMobility
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。