Application Site Atrophy Clinical Trial
Official title:
Clinical Applicability of the Device Belk in the Rehabilitation Process
NCT number | NCT04159623 |
Other study ID # | Belk |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 10, 2020 |
Est. completion date | April 8, 2021 |
Verified date | May 2021 |
Source | Basque Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot, interventional, randomized of parallel groups and multicenter clinical trial.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 8, 2021 |
Est. primary completion date | April 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | IIS Biocruces Bizkaia | Baracaldo | Bizkaia |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of sessions until recovery | 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. | An average of 12 weeks | |
Secondary | March in 10 meters | Number of patients can be walk 10 meters | An average of 12 weeks | |
Secondary | UP&Go test | Do the UP&GO test | An average of 12 weeks | |
Secondary | Number of falls during rehabilitation sessions | Number of falls during rehabilitation sessions | An average of 12 weeks |