Gait Stability After Stroke (AdaptGait)
Influence of Added Tasks and Different Environmental Conditions on Gait Stability After Stroke
The study will investigate gait stability in individuals post-stroke compared with age- and sex-matched healthy adults. Participants will undergo laboratory-based walking assessments under different environmental conditions, including level walking, uphill and downhill walking, and unexpected slip perturbations, with and without added cognitive, postural, and load-carrying tasks. The primary outcome measures will be the Margin of Stability (MOS), step width, and step width variability.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
: The study will recruit 20-30 adults post-stroke and an equal number of healthy controls. Participants post-stroke will be recruited after discharge from their regular rehabilitation. Participants will complete a single assessment session involving walking on a instrumented dual-belt treadmill mounted on a Stewart platform while secured with a safety harness. Walking conditions will include level, inclined, declined, and slip-perturbed walking, as well as walking combined with serial subtraction, head turning, or backpack carrying. Three-dimensional motion capture, force measurements, and surface electromyography will be used to quantify gait biomechanics and neuromuscular responses. The effects of environmental conditions and added tasks on gait stability, balance control, and fall risk will be compared between groups to identify biomechanical and neuromuscular markers associated with increased fall susceptibility after stroke.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Katja Groleger Sršen, MD, PhD
- 電話番号：+386 1 4758283
- メール：katja.groleger@ir-rs.si
研究場所
-
-
-
Ljubljana、スロベニア、1000
- University Rehabilitation Institute, Republic of Slovenia
-
-
参加基準
適格基準
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 - stroke group:
- Discharge from regular rehabilitation
- First unilateral ischemic or hemorrhagic stroke affecting one of the cerebral hemispheres
- More than 3 months post-stroke
- Mini-Mental State Examination score ≥24 or cognitive ability to participate in the study
- Ability to walk independently in the community without a walking aid
- Moderate to mild balance impairment (Mini-BESTest score 16-25)
- Sufficient cognitive and physical ability to participate
- Ability to walk on a treadmill in intervals for up to 30 altogether
Inclusion Criteria - healthy control group:
- Age- and sex-matched to participants with stroke
- Mini-BESTest score ≥ 16
- Sufficient cognitive and physical ability to participate
- Ability to walk on a treadmill in intervals for up to 30 altogether
Exclusion Criteria (both groups):
- Musculoskeletal impairments affecting gait or balance
- Severe cardiovascular disease or heart failure (NYHA Class III-IV)
- Other neurological disorders
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：基礎科学
- 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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Post-stroke patients
Adults with unilateral stroke (>3 months post-stroke) will undergo assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying). |
Level treadmill walking Uphill treadmill walking Downhill treadmill walking Slip-perturbed treadmill walking Added task: serial subtraction Added task: head turning Added task: backpack carrying |
|
アクティブコンパレータ：Control group: healthy control participants
Age- and sex-matched healthy adults will undergo the same assessment protocol as the post-stroke patients, i.e., assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying). |
Level treadmill walking Uphill treadmill walking Downhill treadmill walking Slip-perturbed treadmill walking Added task: serial subtraction Added task: head turning Added task: backpack carrying |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Margin of Stability (MOS)
時間枠：During the intervention (periprocedurally)
|
Margin of stability in the anteroposterior and mediolateral directions calculated from kinematic and kinetic gait data during walking under different environmental conditions and added tasks, expressed in cm (more is better) |
During the intervention (periprocedurally)
|
|
Step Width
時間枠：During the intervention (periprocedurally)
|
Mean step width measured during walking under different environmental conditions and added tasks, expressed in cm (less is better) |
During the intervention (periprocedurally)
|
|
Step Width Variability
時間枠：During the intervention (periprocedurally)
|
Variability of step width calculated across consecutive gait cycles during walking under different environmental conditions and added tasks, , expressed as coeffcient of variation (less is better) |
During the intervention (periprocedurally)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Spatiotemporal Gait Parameter 1: Cadence
時間枠：During the intervention (periprocedurally)
|
Gait cadence (in steps/min; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 2: Step Length
時間枠：During the intervention (periprocedurally)
|
Gait step length (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 3: Stance Time
時間枠：During the intervention (periprocedurally)
|
Gait stance time (in s, less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 4: Swing Time
時間枠：During the intervention (periprocedurally)
|
Gait swing time (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 1: Ground Reaction Force
時間枠：During the intervention (periprocedurally)
|
Ground reaction force in antero-posterior direction (in N; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 2: Center-of-pressure Movement
時間枠：During the intervention (periprocedurally)
|
Center-of-pressure movement in antero-posterior and medio-lateral direction (in cm; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 3: Velocity
時間枠：During the intervention (periprocedurally)
|
Velocity in antero-posterior and medio-lateral direction (in cm/s; smaller is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
協力者と研究者
スポンサー
スポンサー
捜査官
捜査官
- 主任研究者：Metka Močilar, MSc PT、University Rehabilitation Institute, Republic of Slovenia
- スタディディレクター：Urška Puh, PT, PhD、University Rehabilitation Institute, Republic of Slovenia
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- URIS202602
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
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。