Gait Modification for Knee Osteoarthritis (SENSMOD)
15 oktober 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
3
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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British Columbia
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Vancouver, British Columbia, Kanada, V6T 1Z3
- Motion Analysis and Biofeedback Laboratory
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in baseline to week 7 foot rotation angle error during stance - in lab walking
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in baseline to week 7 knee joint moment impulse
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Michael Hunt, PT, PhD, University of British Columbia
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 februari 2020
Primärt slutförande (Faktisk)
12 mars 2020
Avslutad studie (Faktisk)
12 mars 2020
Studieregistreringsdatum
Först inskickad
3 februari 2020
Först inskickad som uppfyllde QC-kriterierna
25 mars 2020
Första postat (Faktisk)
27 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H19-02621
Plan för individuella deltagardata (IPD)
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NEJ
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