Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology (PROTECT)
Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology (PROTECT)
調査の概要
詳細な説明
The PROTECT Study is designed to classify participants into fall-risk categories and evaluate whether use of the LIBERTY Patch, a drug-free, non-invasive, investigational device employing Haptic Vibrotactile Trigger Technology, is associated with a change in fall-risk category or balance/mobility confidence relative to a sham (inactive) patch control.
After informed consent, participants complete a Baseline Survey (including the Falls Efficacy Scale, a 10-item instrument adapted from Tinetti et al., 1990, assessing confidence in performing daily activities without falling) and undergo a brief (2-3 minute) walking and mobility assessment using the FallSkip wearable device, worn at the waist, involving sitting, standing, walking several feet, and returning to a seated position. Participants are then given a study patch - either the active LIBERTY Patch or a visually identical sham patch - to wear daily. After 7 days, participants repeat the FallSkip mobility assessment and complete a Follow-Up Survey, which re-administers the Falls Efficacy Scale and adds items on patch satisfaction, ease of use, convenience, and any side effects experienced (hot/cold sensation, massage/tingling sensation, pressure sensation, or none). Neither the participant nor the investigator is informed of patch assignment during the study period, though the investigator can unblind in case of emergency. After the 7-day period, participants may optionally continue in the study using the alternate patch.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Texas
-
Mansfield、Texas、アメリカ、76063
- Anna Toker, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Ages 55 to 85, inclusive
- Able to provide written informed consent
- Able to walk independently or with assistive devices
- Lucid, with adequate cognitive ability to consent
Exclusion Criteria:
- History of severe neurological disorders (e.g., advanced Parkinson's, severe stroke history)
- Known allergies to adhesives
- Currently hospitalized
- Use of drugs of abuse (illicit or prescription)
- Severe visual/auditory impairments affecting gait or balance
- Terminal illness or life expectancy less than 6 months
- Severe dementia or cognitive impairment preventing consent
- Ongoing physical therapy specifically targeting balance/gait
- Post-stroke
- Pregnant
- Existing or planned implantation of a pacemaker or other electrical device
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Active LIBERTY Patch (Vibrotactile/Haptic)
Participants apply the active LIBERTY Patch (Haptic Vibrotactile Trigger Technology) daily for 7 days, with fall-risk/mobility assessment (FallSkip device) and Falls Efficacy Scale survey completed at baseline and Day 7.
|
A drug-free, non-invasive, investigational topical patch designed to assist with balance and mobility, worn daily for 7 days.
他の名前：
|
|
偽コンパレータ：Control (Sham Patch)
Participants apply a visually identical sham patch without active technology daily for 7 days, with the same baseline and Day 7 assessments as the Active arm.
|
A visually identical patch without active technology, worn daily for 7 days under the same conditions as the active patch.
|
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 |
|---|---|---|
|
Change in fall-risk/mobility assessment (FallSkip device)
時間枠：Baseline and Day 7
|
A 2-3 minute mobility assessment (sit-to-stand, walking, and return to seated position) using the FallSkip wearable device, comparing Active vs.
Control groups.
|
Baseline and Day 7
|
|
Change in Falls Efficacy Scale score
時間枠：Baseline and Day 7
|
A 10-item, self-reported scale (adapted from Tinetti et al., 1990) measuring confidence in performing daily activities (bathing, dressing, walking, transferring, etc.) without falling, scored 1 (very confident) to 10 (not confident at all) per item.
|
Baseline and Day 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of patch-associated sensations/side effects
時間枠：Throughout the 7-day study period, assessed at Day 7
|
Self-reported occurrence of hot/cold sensation, massage/tingling sensation, pressure sensation, or none, associated with patch use.
|
Throughout the 7-day study period, assessed at Day 7
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
- Fason J, Hurwitz P, Gudin J. Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study. Pain Ther. 2025 Dec;14(6):1797-1807. doi: 10.1007/s40122-025-00780-0. Epub 2025 Oct 8.
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- PROTECT-001
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?
IPD プランの説明
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
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。