Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke (SOMADC-CC)
SOMADC-CC (SOMAtic Dysfunction Characterization Following Chronic Cerebrovascular Disease): Biomarker Study
Stroke remains the leading cause of severe disability, and survivors frequently have incomplete recovery. More than half of older survivors have impaired mobility which contributes to poorer quality-of-life (QoL) and suffering. The annual rate of disability compared to myocardial infarction triples, and stroke accelerates natural age-related functional decline. Somatic dysfunction (SD) is impaired function of the body framework identified by physical examination. Few studies have rigorously studied SD among stroke survivors. We recently demonstrated the reliability of a novel, more construct valid osteopathic examination methodology [called the Functional Pathology of the Musculoskeletal System (FPMSS) model] to quantify SD among asymptomatic participants and patients with acute cerebral ischemia. The preliminary findings suggest that dysfunction may develop within the first week after acute ischemic stroke (IS) and be more severe among those with paralysis compared to healthy volunteers. The precise pathophysiologic mechanism underlying SD remains unknown.
The objective of this proposal is to establish the relationship between SD severity during chronic stroke recovery and physiologic biomarkers. The central hypothesis is that SD is quantifiable, correlates with biomarkers that reflect functional status, and is associated with QoL among chronic stroke survivors. There are currently no biomarkers that correlate with SD severity after IS. Establishing valid biomarkers associated with physiologic processes that are otherwise inferred by physical examination would allow for quantification of changes in response to treatment (e.g., osteopathic manipulative treatment; OMT) aimed at restoring economical biomechanical function. Testing this hypothesis will address several fundamental gaps in knowledge about osteopathic palpatory diagnosis, physiologic processes associated with SD, and its association with survivor outcomes. Until these knowledge gaps are filled, optimal strategies to complement stroke recovery in patients with neurological disability cannot fully be determined. The project specific aims are to quantify the association between SD among chronic (>3 months) IS survivors and measured (1) energy expenditure, (2) heart rate variability (HRV), and (3) patient-reported outcome (PRO) health domains.
The proposed research is significant because it will establish a novel osteopathic approach that determines the impact of whole musculoskeletal system (MSS) health on QoL among stroke survivors living with chronic disability and correlate physiologic properties related to SD. This approach will allow us to quantify SD and show meaningful associations with autonomic function, biomechanical economy, and QoL after chronic stroke. These new metrics would then be derived in stroke patients to determine SD and physiologic thresholds for those that would benefit most from OMT in a future trial. This proposal is innovative in that it seeks to shift current research and practice paradigms by re-appraising the impact of whole musculoskeletal functional economy on patient-centered outcomes among stroke survivors. Methodologically, use of the FPMSS model represents a novel, more construct valid, diagnostic paradigm to reliably identify SD and establish an osteopathic, cross-disciplinary approach to the field of stroke research. The model examines the MSS as integrated, highlighting proportionate, not merely symmetrical, posture and motion among survivors with chronic disability. Similarly, PROs have been used to quantify health status after stroke, but have not been used to study the relationship between chronic neurologic impairment and SD. Integrating contemporary patient-centered stroke outcomes, rigorous osteopathic assessment, and analysis of physiologic processes will advance our understanding of how musculoskeletal dysfunction impacts QoL after stroke.
調査の概要
状態
状態
条件
条件
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前:Alan Yee, D.O.
- 電話番号:916-734-3588
- メール:ahyee@ucdavis.edu
研究場所
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California
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Sacramento、California、アメリカ、95817
- 募集
- University of California Davis
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コンタクト:
- Alan Yee, D.O.
- メール:ahyee@ucdavis.edu
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-
参加基準
適格基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
• UC Davis Stroke Clinic outpatient patients >3 months from previous stroke
- Adults ≥18 years
Previous admission diagnosis or referral indication:
o Ischemic stroke (prior history of)
- Able to sit upright, lie supine, and lie lateral recumbent left/right positions
- Must be able to walk independently with/without walking aids.
- Participants must have the capacity to consent to study participation themselves or have a Legally Authorized Representative (LAR) available.
- Willingness to receive SMS (text) messages and/or email to complete REDCap QoL survey
Exclusion Criteria:
• Acute skeletal fracture or known dislocation; history of pathologic (osteoporotic or neoplastic) skeletal fracture of thoracic cage, hip/pelvis/sacrum, or vertebral column
- Spinal column support brace (e.g. cervical collar)
- History of spinal cord injury with residual neuromuscular or sensory disability
- Clinical condition that would interfere with execution of movement or palpatory diagnostic testing, e.g. prohibitive chronic pain
- Participants who have received either OMT or chiropractic manipulation following their stroke and prior to enrollment.
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
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
|---|
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Ambulatory post-ischemic stroke patients (> 3 months after stroke)
Adult patients who have a history of ischemic stroke more than 3 months prior to study enrollment are eligible. Ambulatory patients seen at the UC Davis Stroke Center will be screened for eligibility. Participants must be have the ability to sit upright, lie supine, and lie lateral recumbent to undergo musculoskeletal examination. |
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 |
|---|---|---|
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6 Minute Walk Test
時間枠:6 minute duration to be performed a single time.
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Participants will walk for 6 consecutive minutes, be allowed to rest and wear support devices as needed, and have their heart rate and waling speed quantified.
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6 minute duration to be performed a single time.
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Somatic dysfunction
時間枠:15-25 minutes, single instance
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participants will undergo osteopathic musculoskeletal examination based on applying Functional Pathology of the Musculoskeletal System (FPMSS) criteria to quantify somatic dysfunction --defined as proportionate loss of range of motion during passive testing
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15-25 minutes, single instance
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Physiologic Cost Index
時間枠:6 minute duration of walking, single instance
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Quantify energy expense of ambulation among chronic stroke survivors
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6 minute duration of walking, single instance
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Heart Rate Variability
時間枠:5 minutes, single instance
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Examine resting heart rate variability among chronic stroke survivors
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5 minutes, single instance
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協力者と研究者
捜査官
捜査官
- 主任研究者:Alan Yee, D.O.、University of California, Davis
出版物と役立つリンク
便利なリンク
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
キーワード
その他の研究ID番号
その他の研究ID番号
- 2374498-1
- 26151929 (その他の助成金/資金番号:American Osteopathic Association)
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
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