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治験 NCT05859815（対象：脳震盪、軽度外傷性脳損傷）は募集中です。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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The Role of Mechanical Diagnosis and Therapy in the Management of Concussion
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」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 NCT05859815 は 観察研究 臨床試験 で、脳震盪、軽度外傷性脳損傷 に関するものです。現在は 募集中 で、2023年7月20日 から開始しています。100 名の参加者 の募集が計画されています。この治験は State University of New York at Buffalo によって主催され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年6月27日 です。
概要
The purpose of this study is to examine the role of a Mechanical Diagnosis and Therapy (MDT) examination in identifying participants diagnosed with concussion who display a directional preference compared to who don't display a directional preference.
詳細説明
Directional preference describes the clinical phenomenon where a specific direction of repeated movement and / or sustained position results in a clinically relevant improvement in symptoms. This improvement is usually accompanied by an improvement in function or mechanics or both. Its presence and relevance is determined over 2-3 visits. This study aims to identify the proportion of participants with concussion who present with a directional preference during the course of physical therapy. A secondary aim of this study is to investigate whether directional preference is associated with the eventual patient related outcomes following care.
公式タイトル
The Role of Mechanical Diagnosis and Therapy in the Classification and Management of Concussion
疾患／病気
脳震盪軽度外傷性脳損傷その他の研究識別子
- STUDY00006666
NCT番号
開始日
2023-07-20
最終更新日
2025-06-27
終了予定日
2026-06-30
目標参加者数
100
試験の種類
観察研究
状況
募集中
キーワード
Mechanical Diagnosis and Therapy
Directional Preference
Repeated Movements
Directional Preference
Repeated Movements
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Directional preference responder This group is comprised of participants who responded to repeated movements in a direction (e.g., neck flexion) that significantly improved their symptoms and/or their ability to move their head/neck. | 理学療法 As part of their normal care, participants will receive any combination of the following interventions to address their specific needs identified during the initial evaluation: cervical spine repeated movements (active range of motion), cervical spine stabilization exercise, aerobic exercise, motor control training, oculomotor/vestibular rehabilitation, stretching, soft-tissue mobilization, joint mobilization, and postural re-education activities. |
Directional preference non-responder This group is comprised of participants who did not respond to repeated movements in any specific direction that significantly improved their symptoms and/or their ability to move their head/neck. | 理学療法 As part of their normal care, participants will receive any combination of the following interventions to address their specific needs identified during the initial evaluation: cervical spine repeated movements (active range of motion), cervical spine stabilization exercise, aerobic exercise, motor control training, oculomotor/vestibular rehabilitation, stretching, soft-tissue mobilization, joint mobilization, and postural re-education activities. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Directional preference classification | Outcome represents the patient's directional preference at the time of discharge from care. Patients will be classified as directional preference responders or non-responders. | Through study completion, up to 1 year. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Post-Concussion Symptom Scale | The PCSS is a patient self-reported outcome measure that measures the amount of interference associated with a concussion across four domains: physical, cognitive, emotion, and sleep. The measure consists of 22 questions that relate to post-concussive symptoms. The measure uses a 7-point Likert scale, where 0 = no symptoms and 6 = severe symptoms. The greatest possible score is 132 and the lowest score is 0. Higher scores indicate higher severity of post-concussive symptoms. | Through study completion, up to 1 year. |
Neck Disability Index | The NDI is a patient self-reported outcome measure that measures the amounts of pain interference and self-reported disability related to neck pain. The measure consists of ten questions in the following domains: pain intensity, personal care, lifting, reading, sleeping, work, recreation, reading, concentration, and headaches. Each item is rated on a 0 to 5 scale, where 0 = no disability and 5 = complete disability. The highest possible raw score equals 50 points, the lowest possible score equals 0. The raw scores can also be converted to a percentage from 0 to 100%. Higher scores indicate higher levels of self-reported disability. | Through study completion, up to 1 year. |
Dizziness Handicap Inventory | The DHI is a patient self-reported outcome measure that measures the impact of dizziness on daily life. The DHI consists of 25 items measuring the impact of dizziness across three domains: functional (9 questions,= 36 points), emotional (9 questions = 36 points), and physical (7 questions = 28 points). Each item is rated on a 3 point scale (yes = 4, sometimes = 2, no = 0). Item scores are summed, with a possible total of 100 points. The best possible score is a 0. Higher scores indicate greater perceived handicap due to dizziness. | Through study completion, up to 1 year. |
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
13 Years
対象性別
全て
- Age = 13 - 65
- Complaints of neck pain, headache, or dizziness associated with a diagnosis of concussion or mild TBI
- Ability to read/write English
- Referral from physician
- Age less than 13 or greater than 65
- Cause of symptoms is result of a work-related accident or motor vehicle accident
- Receiving concurrent treatment from a chiropractor or massage therapist
- Glasgow Coma Scale less than 12
- Lesion on head CT/MRI
- Focal neurological deficits associated with serious spinal pathology (fracture, infection, tumor, vertebrobasilar insufficiency)
- Inability to or unwilling to exercise as part of usual PT care
- Unable to read/write English
- History of osteopenia/osteoporosis or cancer
State University of New York at Buffalo責任者
Michael Brown, 研究責任者, Clinical Assistant Professor, State University of New York at Buffalo
試験中央連絡先
連絡先: Michael R Brown, DPT, PhD, 716-829-6801, [email protected]
2 1カ国の場所
Illinois
Goodlife Physical Therapy, Orland Park, Illinois, 60467, United States
Mickey Shah, DPT, 連絡先, 708-966-4386, [email protected]
Mickey Shah, DPT, 研究責任者
募集中
New York
Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center, Niagara Falls, New York, 14304, United States
Margaux Lojacano, DPT, 連絡先, 716-998-7947, [email protected]
Margaux Lojacano, DPT, 研究責任者
募集中