Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk ) (DigiWalk)
Falls are a health issue that is both common among older adults (affecting 1 in 2 people each year after age 80) and serious due to their traumatic, psychological, and functionally disabling complications. The international literature shows that it is possible to prevent recurrent falls by addressing the risk factors for falls, particularly by combating a sedentary lifestyle and deconditioning through regular standing and mobility exercises as part of a rehabilitation program. As part of France's major national plan to prevent falls among older adults, and at a time when medicine is becoming increasingly personalized, prescribing a digitally assisted self-rehabilitation program for people over 65 following a fall could enable as many people as possible to benefit from rehabilitation that boosts their motivation and reduces the time spent by healthcare professionals, while ensuring high-quality follow-up care.
LNA Santé, in collaboration with the Angers and Nantes University Hospitals, has developed a personalized, digitally assisted fall prevention program (the Stand'hop app) comprising three types of activities: tailored physical exercises, structured lifestyle advice, and an objective measurement of the patient's physical activity. Before moving forward with a larger-scale clinical trial to evaluate the effectiveness of this personalized, digitally assisted fall prevention program, the present study DigiWalk aims to describe changes in walking performance over 7 weeks among older adults who have experienced falls, when the program is used as an adjunct to standard care, compared to changes observed in older adults who have experienced falls and receive only standard care.
調査の概要
詳細な説明
The main objective is to compare changes in spatiotemporal gait parameters, after 7 weeks of intervention, in :
- Elderly fallers with a digitally assisted self-rehabilitation program in addition to standard care
- Elderly fallers with standard rehabilitation care
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：DRCI Promotion Interne
- メール：DRCI-Promotion-Interne@chu-angers.fr
研究連絡先のバックアップ
- 名前：Issam BILAL, MS
- 電話番号：+33 02.41.35.68.28
- メール：Issam.Bilal@chu-angers.fr
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients aged 65 and older Fall at least once in the previous 3 months , requiring rehabilitation care from a physical therapist
- Signed informed consent or consent from a third party (trusted individual, family member, or close relative)
- Individuals physically capable of following a rehabilitation program (standard care, with or without digital assistance) and of wearing a watch
- Individuals capable of following a self-rehabilitation program as well as the study procedures independently or with the assistance of a caregiver if needed
- Patients enrolled in or covered by a social security program
Exclusion Criteria:
- A person deprived of liberty by an administrative or judicial decision, a person undergoing involuntary psychiatric treatment, or an adult subject to a legal protective measure
- Contraindications to rehabilitation programs offered following a fall (standard care, with or without digital assistance)
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：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
偽コンパレータ：対照群
|
Standard rehabilitation care
|
|
アクティブコンパレータ：介入グループ
|
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.
|
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 |
|---|---|---|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
時間枠：this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : Percentage of double support time Spatiotemporal gait parameters as measured using GAITRite®
時間枠：this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : Coefficient of variation of stride time Spatiotemporal gait parameters as measured using GAITRite®
時間枠：this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
|
|
Walking speed (km/h).
時間枠：this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
Walking speed (km/h).
Spatiotemporal gait parameters as measured using GAITRite®
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of falls
時間枠：baseline, 3 weeks and 7 weeks (8 maximum)
|
baseline, 3 weeks and 7 weeks (8 maximum)
|
|
|
Gait stability measured by a smartwatch paired with an iPhone (in percentage)
時間枠：1 week and 7 weeks (8 weeks max)
|
Apple Healthkiit / appleWalkingSteadiness : Samples that match the Walking Steadiness identifier use percentage units (described in HKUnit)
|
1 week and 7 weeks (8 weeks max)
|
|
Time spent performing activities involving whole-body movements (minutes), measured by a smartwatch paired with an iPhone.
時間枠：1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Number of hours per day during which the participant stood and moved for at least one minute per hour. Measured by a smartwatch paired with an iPhone.
時間枠：1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Time spent standing (minutes), measured by a smartwatch paired with an iPhone.
時間枠：1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Maximal oxygen consumption (VO₂max), measured by a smartwatch paired with an iPhone.
時間枠：1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Number of daily steps, measured by a smartwatch paired with an iPhone.
時間枠：1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Changes in the number of calories burned per day Calories burned per day, are measured by a smartwatch paired with an iPhone.
時間枠：1 week and 7 weeks (8 maximum)
|
1 week and 7 weeks (8 maximum)
|
|
|
Number of hospitalizations since the V1 visit
時間枠：3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Change of residence since the V1 visit (Yes or No)
時間枠：3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Changes in functional abilities measured by "Activities of Daily Living" (ADL) score (6 items)
時間枠：baseline and 7 weeks (8 weeks maximum)
|
_ /6 ; 0 being the worse and 6 the better
|
baseline and 7 weeks (8 weeks maximum)
|
|
Death (Yes or No)
時間枠：3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Program adherence is measured by the number of completed self-rehabilitation sessions for Intervention Group
時間枠：7 weeks (8 weeks maximum)
|
7 weeks (8 weeks maximum)
|
|
|
Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score
時間枠：baseline and 7 weeks (8 weeks maximum)
|
_/12; Adding up the scores from all the tests yields an overall performance score out of 12.
A score below 8 indicates a risk of sarcopenia.
|
baseline and 7 weeks (8 weeks maximum)
|
|
Number of falls showing signs of severity
時間枠：baseline, 3 weeks and 7 weeks (8 maximum)
|
If at least one fall met the criteria for severity, how many falls show signs of severity ?
|
baseline, 3 weeks and 7 weeks (8 maximum)
|
|
Changes in functional abilities measured by Instrumental Activity of Daily Living (IADL) score (4 items)
時間枠：baseline and 7 weeks (8 weeks maximum)
|
_ /4; 0 being the worse and 4 the better
|
baseline and 7 weeks (8 weeks maximum)
|
協力者と研究者
捜査官
- 主任研究者：Cédric ANNWEILER, Pr.、Angers Universitary Hospital (CHU)
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
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