No registrations found.
ID
Source
Brief title
Health condition
Acute ankle sprain
Sponsors and support
Intervention
Outcome measures
Primary outcome
The total number of re-sprains reported after 1-year follow-up.
Secondary outcome
a) Subjective recovery after 1-year follow-up, on a 7-point Likert scale. Patients are deemed to be recovered if they rate themselves as “fully recovered” or “strongly recovered”.
b) Pain at rest and during activity (11 point-NRS)
c) Function (Ankle Function Score)
d) Return to sport
e) Cost-effectiveness of the intervention
f) Compliance of the intervention (completed at least 75% of the training sessions)
Background summary
Rationale: Ankle sprains are the most frequent traumas of the musculoskeletal system, with yearly around 650.000 new sprains in the Netherlands. Of these, about 130.000 people will visit the general practitioner (GP) each year. The Dutch NHG-guideline summarizes the evidence on the potential treatments for acute ankle sprains; however there is very little guidance for treatment. No optimal treatment modality has proven to be effective in general practice.
Objective: To examine the effectiveness of an unsupervised e-health supported neuromuscular training program in combination with usual care in general practice compared to usual care alone in patients with acute lateral ankle sprains in general practice.
Study design: Randomized Controlled Trial (RCT)
Study population: Patients with an acute lateral ankle sprain, aged between 14 and 65 years, and visiting the general practitioner within three weeks of injury.
Intervention: The intervention group will receive, in addition to usual care, a standardized eight-week neuromuscular training program guided by an App. The control group will receive usual care in general practice alone.
Main study parameters/endpoints: The total number of re-sprains reported after 1-year follow-up.
Study objective
An unsupervised e-health supported neuromuscular training program, in addition to usual care in general practice, is more effective compared to usual care alone as a treatment for patients with acute lateral ankle sprains in general practice.
Study design
Online questionnaires will be administered monthly: at baseline, after 4, 8, 12, 16, 21, 26, 31, 35, 39, 43, 47, and 52 weeks follow-up.
Intervention
Group 1. The neuromuscular training program:
Subjects allocated to the intervention group receive a standardized eight-week neuromuscular training program, based on the training program described by Hupperets et al. (2008), in addition to usual care (information leaflet).
PO BOX 2040
M. Middelkoop, van
Rotterdam 3000 CA
The Netherlands
010-7032114
m.vanmiddelkoop@erasmusmc.nl
PO BOX 2040
M. Middelkoop, van
Rotterdam 3000 CA
The Netherlands
010-7032114
m.vanmiddelkoop@erasmusmc.nl
Inclusion criteria
Patients with an acute lateral ankle sprain are eligible for this study if they are aged between 14 and 65 years, visit the general practitioner within three weeks of injury and sign an informed consent.
Exclusion criteria
Patients are excluded if: they have a history of an injury of the same ankle during the previous year; they have had a fracture of the same ankle; they have no understanding of Dutch language.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4614 |
| NTR-old | NTR4765 |
| Other | 80-83910-98-13003 : MEC-2014-250 |