Gangtrening for løpere med patellofemoralt smertesyndrom
Gangtreningintervensjon for kvinnelige løpere med patellofemoralt syndrom: Randomisert kontrollert studie
Patellofemoral pain (PFP) is a common overuse injury in runners. Increased patellofemoral joint stress (PFJS) is an important biomechanical factor associated with PFP. Gait retraining, especially cadence modification, may reduce PFJS and improve symptoms, but evidence from randomized controlled trials remains limited. This study investigated whether wearable device-assisted gait retraining was more effective than education alone in reducing pain, improving function, and altering running biomechanics in female runners with PFP.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Beijing, Kina
- Beijing Sport University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female, Age 18-45 years
- Unilateral/bilateral anterior knee pain > 4 weeks
- VAS pain ≥ 3/10 during running and ≥ 2 of the following: jumping, squatting, kneeling, stairs, prolonged sitting, or resisted knee extension
- Running ≥ 15 km per week
- Natural rearfoot striker
Exclusion Criteria:
- Acute trauma, history of patellar dislocation, meniscal/chondral lesions
- Prior knee surgery or injection in past 12 months
- Rheumatologic, neurologic, or degenerative disease
- Pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Gait retraining group
Participants received a 6-week gait retraining program plus patient education. |
The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain. PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
|
Aktiv komparator: Control group
Participants received a 6-week patient education program |
PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analogue Scale for Pain during running
Tidsramme: Baseline, Week 6, Week 18
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The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated during running. |
Baseline, Week 6, Week 18
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale for usual pain
Tidsramme: Baseline, Week 6, Week 18
|
The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for usual pain. |
Baseline, Week 6, Week 18
|
|
Anterior Knee Pain Scale
Tidsramme: Baseline, Week 6, Week 18
|
The Anterior Knee Pain Scale (AKPS), also referred to as the Kujala Score, is a patient-reported outcome measure designed to evaluate symptoms and functional limitations associated with anterior knee pain and patellofemoral disorders. It consists of 13 items covering domains such as pain during various activities (e.g., walking, running, jumping, climbing stairs, squatting), functional limitations, abnormal gait, muscle atrophy, and difficulty with prolonged sitting. Each item is scored on an ordinal scale, and the total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms. |
Baseline, Week 6, Week 18
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Knee Flexion Angle
Tidsramme: Baseline, Week 6
|
Peak knee flexion angle will be assessed during running trials using a 3-dimensional motion capture system. Reflective markers will be placed according to a standard lower-limb biomechanical model. |
Baseline, Week 6
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Ground Reaction Force
Tidsramme: Baseline, Week 6
|
Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. |
Baseline, Week 6
|
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Visual Analogue Scale for the worst pain
Tidsramme: Baseline, Week 6, Week 18
|
The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for the worst pain. |
Baseline, Week 6, Week 18
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Step rates
Tidsramme: Baseline, Week 6
|
Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min). |
Baseline, Week 6
|
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Weekly running distance
Tidsramme: Baseline, Week 6
|
Weekly running distance refers to the total distance covered by a participant through running over one week, usually expressed in kilometers (km) or meters (m). This outcome is used to assess running volume. |
Baseline, Week 6
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Haonan Wang, Beijing Sport University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 277S
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
What IPD will be shared:De-identified individual participant data that underlie the results reported in the publication, including baseline characteristics, outcome measures (pain scores, functional scores, running mechanics), and adverse events.
When will IPD be available:
Beginning 6 months after publication of the main trial results, for up to 5 years.
With whom:
Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.
For what types of analyses:
For individual participant data meta-analyses and reproducibility purposes.
How to access data:
Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.
IPD-delingstidsramme
Beginning 6 months after publication of the main trial results, for up to 5 years.
Tilgangskriterier for IPD-deling
With whom: Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.
For what types of analyses:
For individual participant data meta-analyses and reproducibility purposes.
How to access data:
Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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