Clinical Applicability of the Device Belk in the Rehabilitation Process
Not Applicable
Completed
- Conditions
- Application Site Atrophy
- Interventions
- Device: Belk DeviceOther: Standard Rehabilitative treatment
- Registration Number
- NCT04159623
- Lead Sponsor
- Basque Health Service
- Brief Summary
Pilot, interventional, randomized of parallel groups and multicenter clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Patients of both sexes.
- Patients aged between 18 and 85 years.
- Patients with knee arthroplasty in the immediate postoperative period.
- Sign in informed consent.
Exclusion Criteria
- Physical or psychological pathologies that prevent patient participation.
- Tumor arthroplasty.
- Knee replacement prosthesis.
- Impossibility of holding the device.
- Patients with a pacemaker.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Belk Device Belk Device With Belk Device Standard Rehabilitative treatment Standard Rehabilitative treatment With the standard rehabilitative treatment
- Primary Outcome Measures
Name Time Method Number of sessions until recovery An average of 12 weeks It is considered that the patient has completed the rehabilitation treatment when he has achieved an arc of movement between 0 and 100 degrees of flexion, a quadriceps muscle balance greater than or equal to 4/5 according to MRC (Medical Research Council)and a stable march with crutches.
- Secondary Outcome Measures
Name Time Method UP&Go test An average of 12 weeks Do the UP\&GO test
March in 10 meters An average of 12 weeks Number of patients can be walk 10 meters
Number of falls during rehabilitation sessions An average of 12 weeks Number of falls during rehabilitation sessions
Trial Locations
- Locations (1)
IIS Biocruces Bizkaia
🇪🇸Baracaldo, Bizkaia, Spain