Ankle Injuries and Disorders Clinical Trial
Official title:
Evaluation of the Effect of Manual Therapy and the Application of Plantar Orthoses in Amateur Runners With Ankle Range of Motion Restriction. A Randomised Clinical Trial.
Verified date | January 2024 |
Source | Fundación Universidad Católica de Valencia San Vicente Mártir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Limitation of ankle dorsiflexion is directly related to pronated foot. For its treatment, plantar orthoses and manual therapy are used. There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 11, 2023 |
Est. primary completion date | December 11, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Runners who run on asphalt. - Individuals who run at least >6 hours per week for 6 months prior to study participation. - Participants with hyperpronated feet secondary to ankle ROM limitation. - Runners with an ankle DF difference of >1.5cm in both feet or an ankle DF of less than 11.5cm according to the Lunge Test. Exclusion Criteria: - Individuals who have suffered a major injury in the previous two months. - FPI less than 6. - Runners wearing minimalist footwear into which PO cannot be inserted. - Individuals already undergoing treatment with plantar supports. - Chronic widespread pain, including fibromyalgia. - Systemic rheumatic pathologies. - History of recent trauma or surgery |
Country | Name | City | State |
---|---|---|---|
Spain | Juan Vicente-Mampel | Torrent | Valencia |
Lead Sponsor | Collaborator |
---|---|
Fundación Universidad Católica de Valencia San Vicente Mártir |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks | Measured with Kinovea software. The patient will be recorded running in slow motion and the peroneal malleolus, the centre of the heel by the lateral edge and the head of the V metatarsal will be marked. It will then be analysed using Kinovea software | At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks) | |
Secondary | Degrees of DF of the ankle in closed kinetic chain with the Lunge Test using LegMotion | Lung Test will measure the distance between the toes and the Legmotion stirrup, which has been shown to have a moderate to excellent intra-rater reliability (ICC = 0.65-0.99) with a minimum detectable change of 1.9 cm and 4.7°. | At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks) | |
Secondary | Degrees of pronation in dynamics, measured with Runscribe (DP) | Runsribe sensors will be placed on the runners while they run. Data will be recorded with the official Runscribe App. This method is validated by Lewin et al. | At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks) | |
Secondary | Foot Function Index | FFI for the assessment of pain, disability and limitation of foot function, recommended for use in both clinical and research settings. | At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
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