Rehabilitation After Lower Extremity Nailing Trial (ReLENT)
The goal of this clinical trial is to learn if outpatient physical therapy (PT) results in differing functional outcomes compared to a self-guided home exercise program (HEP) in tibial or femoral nail patients. The hypothesis is that outpatient PT does not result in superior functional outcomes when compared to a self-guided home exercise program. Outpatient physical therapy for mobility and gait training is the current standard of care following lower extremity fractures.
To test this question, patients will be randomized into either PT or HEP group with PT serving as the control. Researchers will compare the PT and HEP groups to see if patient outcomes differ.
People who agree to join the study will be asked to attend 5 visits over one year. During these visits, they will receive surveys and physical assessments. They will also be asked to answer survey questions about their pain, recovery, and therapy through an email survey. The emailed surveys will be weekly for the first 3 months, then every 2 weeks until 6 months, then every 4 weeks until one year. There are 24 emailed surveys total.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 or older
- Unstable femoral or tibial shaft fracture treated with a locked intramedullary nail
- Willing and able to provide informed consent
Exclusion Criteria:
- Patients with weight-bearing or range of motion restrictions
- Patients treated surgically more than 3 weeks prior
- Previously non-ambulatory patients
- Pre-existing functional deficit of the lower extremities
- Patients over the age of 60 years
- Non-English-speaking patients
- Patients unwilling or unlikely to attend follow-up visits
Patients who sustain:
- Polytraumatic injuries that preclude the use of assistive devices
- Closed head injury limiting cognition
- Nerve injury resulting in motor deficits
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：処理
- 割り当て：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 |
|---|---|
|
アクティブコンパレータ：Formal Physical Therapy (PT)
Patients will be provided with a standardized prescription for outpatient PT.
The details of the prescription have been developed with the University of Chicago Medicine Physical Therapy Department.
Treatment will be prescribed for 2 sessions per week for a period of 6 weeks.
|
Formal Physical Therapy (PT)
|
|
アクティブコンパレータ：Home Exercise Program (HEP)
Home exercise program (HEP) instructions will be provided to the HEP cohort and will include standardized exercises divided into three phases.
Progress through phases is based on functional criteria and is self-determined.
|
Home Exercise Program (HEP)
|
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 |
|---|---|---|
|
Difference in SFMA (Selective Functional Movement Assessment) at 90 days
時間枠：Baseline, 90 days
|
The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals.
|
Baseline, 90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured in degrees
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in thigh circumference
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured in cm.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in gait speed
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured by timing how long it takes to walk a set distance and dividing the distance by the time.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in 30-second chair stand
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Count the number of times the patient comes to a full standing position in 30 seconds from a chair.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in stair climb power test
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measure of ability to ascend and descend a flight of stairs.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Any difference in VAS Pain Scale
時間枠：Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
The Visual Analogue Scale (VAS) for pain is a 100 mm line labeled "no pain" at 0 mm and "worst imaginable pain" at 100 mm
|
Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome-Yellow Flag)
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
The OSPRO-YF is designed to help healthcare practitioners identify pain-related psychological characteristics in outpatient orthopedic settings.
As OSPRO-YF summarizes 11 psychological questionnaires, it is not scored like a conventional screening tool.
Quartile scores are used instead of cutoff scores for consistency and assessment of a wide range of outpatient orthopedic patients.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in PROMIS Physical Function 8b short form
時間枠：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
The PROMIS Physical Function form is a self-reported questionnaire assessing an individual's capability to perform daily physical activities.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mary K Erdman, M.D.、The University of Chicago Medical Center
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
本研究に関する用語
その他の研究ID番号
- IRB25-0850
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?
IPD プランの説明
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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