Gait Modification for Knee Osteoarthritis (SENSMOD)
2020年10月15日 更新者：Michael Hunt、University of British Columbia
Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention.
Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.
調査の概要
詳細な説明
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA).
Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy.
However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown.
Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning.
No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes.
Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results.
This study will address these gaps.
The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.
研究の種類
介入
入学 (実際)
3
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V6T 1Z3
- Motion Analysis and Biofeedback Laboratory
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Be 50 years of age or greater
- Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
- Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
- Are comfortable walking intermittently for 30 minutes
- Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
- Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.
Exclusion Criteria:
- Any knee surgery or intraarticular injections within the past 6 months
- A history of joint replacement surgery or high tibial osteotomy
- Current or recent (within 6 weeks) corticosteroid injections
- Use of a gait aid
- Currently on a wait list for joint replacement surgery or high tibial osteotomy
- Any inflammatory arthritic condition
- Any other conditions that may affect normal gait or participation in an aerobic exercise program
- Cannot attend all required appointments.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Specific Modification Target
A 15 degree relative increase to foot progression angle
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Participants will be instructed to increase their baseline foot progression angle by 15 degrees.
Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror).
Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.
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実験的：Self-directed Modification
A self-directed increase to foot progression angle that is "as much as is comfortable".
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Participants will be instructed to modify their foot progression angle as much as is comfortable.
A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.
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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 |
|---|---|---|
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Change in baseline to week 7 foot rotation angle error during stance - in lab walking
時間枠：Baseline, Week 7
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Foot rotation is the specific walking parameter that will be modified during the intervention.
It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction.
Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
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Baseline, Week 7
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Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
時間枠：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
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Foot rotation is the specific walking parameter that will be modified during the intervention.
It is defined as the angle between the long axis of the foot and the walking direction.
Foot rotation will be measured via sensor-based motion capture over each week of the intervention.
Median and inter-quartile ranges will be taken as the primary summary statistic.
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Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in baseline to week 7 knee joint moment impulse
時間枠：Baseline, Week 7
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Knee flexion and adduction moment impulses will be calculated.
Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks.
Moments will be calculated using an inverse dynamics approach.
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Baseline, Week 7
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Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
時間枠：Baseline, Week 7
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Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis.
The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
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Baseline, Week 7
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Change in baseline to week 7 knee pain on a numerical rating scale
時間枠：Baseline, Week 7
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Knee pain rated on a 0 to 10 scale.
0 = "no pain at all" and 10 = "worst pain imaginable".
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Baseline, Week 7
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Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
時間枠：Week 1, 7
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Difficulty will be rated on a 0 to 10 scale.
0 = "no difficulty at all" and 10 = "most difficulty imaginable".
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Week 1, 7
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Michael Hunt, PT, PhD、University of British Columbia
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年2月20日
一次修了 (実際)
2020年3月12日
研究の完了 (実際)
2020年3月12日
試験登録日
最初に提出
2020年2月3日
QC基準を満たした最初の提出物
2020年3月25日
最初の投稿 (実際)
2020年3月27日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月19日
QC基準を満たした最後の更新が送信されました
2020年10月15日
最終確認日
2020年10月1日
詳しくは
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。
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