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治験 NCT06838455(対象:Osteoarthritis (OA) of the Hip)は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility 53 運動療法
治験(臨床試験)の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします!「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06838455 は 介入研究 臨床試験 で、Osteoarthritis (OA) of the Hip に関するものです。現在は 募集準備中 で、2025年2月1日 に開始予定です。53 名の参加者 の募集が計画されています。この試験は Colorado Joint Replacement によって主導され、2025年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年2月20日 です。
概要
The purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement.
公式タイトル
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
疾患名
Osteoarthritis (OA) of the Hip刊行物
この臨床試験について発表された科学記事と研究論文:その他の研究識別子
- 2279537
主目的
診断
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし(非盲検)
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Spinopelvic Exercise Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. | Spinopelvic mobility exercise Participants will complete a 15-20 min session of therapeutic exercises performed by patients with assistance of a pre-recorded video. The exercise regimen has been developed by the investigators of this study to incorporate exercises to increase a patient's spinopelvic mobility. Study staff that has been properly trained will be present to guide the patient through the exercise regimen and ensure the exercises are b...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Spinopelvic radiographic measurements | Spinopelvic parameter measurements on pre- and post-exercise radiographs including pelvic incidence, pelvic tilt, sacral slope and lumbar lordosis. All measurements are angles calculated in degrees. | Change from baseline to up to 1 hour after spinopelvic exercises same day. |
Lumbar mobility | Calculated as the change in angle of lumbar lordosis between neutral standing and flexed-forward seated radiographs. | Change from baseline to up to 1 hour after spinopelvic exercises same day |
Spinopelvic mobility | Calculated as the change in angle of pelvic tilt between neutral standing and flexed-forward seated radiographs. | Change from baseline to up to 1 hour after spinopelvic exercises same day |
Patient risk classification for THA instability | Risk classification based on previously published risk factors for THA instability (lumbar stiffness, abnormal pelvic mobility, standing pelvic tilt greater than 13, sagittal spinal deformity) | Change from baseline to up to 1 hour after spinopelvic exercises same day |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Oswestry Disability Index score | Patient reported outcome for pre-existing back pain and disability. The questionnaire is comprised of 10 sections, where each section is scored on a scale from 0 to 5 and summed. Higher score totals indicates worse disability. | Baseline |
Hip Society Score | Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes. | Baseline |
Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) | Patient reported outcome, scored from 0 to 100. Higher scores indicate better outcomes. | Baseline |
The Veterans Rand 12-Item Health Survey scores (VR-12) | Patient reported outcome. Scores are reported as a Z-score that is based on the United States population average of 50. Higher scores indicate better outcomes. | Baseline |
Use of medication for hip/back pain | Assessed by standard of care questionnaire prior to the pre-operative visit with provider for a total hip replacement. | Baseline |
Severity of hip arthritis | Graded using Kellgren-Lawrence scale for osteoarthritis on AP radiographs. Grades are between 0-4, where 0 indicates an absence of osteoarthritis and a 4 indicates severe osteoarthritis. | Baseline |
Adverse events | Any adverse events sustained from therapeutic exercises | Day 1 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Patients aged 18-90 scheduled for total hip arthroplasty
- Patients with primary hip osteoarthritis
- Patients with or without history of prior spinal injections
- Patients undergoing revision total hip arthroplasty.
- Patients with spinal fusion.
- Patients who exercised prior to radiographic analysis.
- Patients unable to complete imaging at the designated time of day.
- Symptomatic contralateral hip osteoarthritis.
- Patients unwilling or unable to perform therapeutic exercise program as instructed. This includes patients requiring use of assistive devices or who would be deemed unsafe to perform the exercises without a 1- or 2-person assist.
責任者
Jason Jennings, 主任研究者, Orthopedic Surgeon, Colorado Joint Replacement
試験中央連絡先
連絡先: Makenna Hemmerle, MS, 3032602951, [email protected]
位置情報がありません。