- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07557797
Gångomträning för löpare med patellofemoralt smärtsyndrom
Gångomträningsintervention för kvinnliga löpare med patellofemoralt smärtsyndrom: randomiserad kontrollerad 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Beijing, Kina
- Beijing Sport University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale for Pain during running
Tidsram: 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 during running. |
Baseline, Week 6, Week 18
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale for usual pain
Tidsram: 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
Tidsram: 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
|
|
Knee Flexion Angle
Tidsram: 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
|
|
Ground Reaction Force
Tidsram: Baseline, Week 6
|
Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. |
Baseline, Week 6
|
|
Visual Analogue Scale for the worst pain
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Step rates
Tidsram: 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
|
|
Weekly running distance
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Haonan Wang, Beijing Sport University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 277S
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Beginning 6 months after publication of the main trial results, for up to 5 years.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
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