Back to resultsClinical Applicability of the Device Belk in the Rehabilitation Process
Primary Purpose
Application Site Atrophy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Belk Device
Standard Rehabilitative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Application Site Atrophy
Eligibility Criteria
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.
Sites / Locations
- IIS Biocruces Bizkaia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Belk Device
Standard Rehabilitative treatment
Arm Description
With Belk Device
With the standard rehabilitative treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
March in 10 meters
Number of patients can be walk 10 meters
UP&Go test
Do the UP&GO test
Number of falls during rehabilitation sessions
Number of falls during rehabilitation sessions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04159623
Brief Title
Clinical Applicability of the Device Belk in the Rehabilitation Process
Official Title
Clinical Applicability of the Device Belk in the Rehabilitation Process
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Pilot, interventional, randomized of parallel groups and multicenter clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Application Site Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Belk Device
Arm Type
Experimental
Arm Description
With Belk Device
Arm Title
Standard Rehabilitative treatment
Arm Type
Other
Arm Description
With the standard rehabilitative treatment
Intervention Type
Device
Intervention Name(s)
Belk Device
Intervention Description
Knee exoskeleton with electrostimulation
Intervention Type
Other
Intervention Name(s)
Standard Rehabilitative treatment
Intervention Description
Use the standard rehabilitative treatment
Primary Outcome Measure Information:
Title
Number of sessions until recovery
Description
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.
Time Frame
An average of 12 weeks
Secondary Outcome Measure Information:
Title
March in 10 meters
Description
Number of patients can be walk 10 meters
Time Frame
An average of 12 weeks
Title
UP&Go test
Description
Do the UP&GO test
Time Frame
An average of 12 weeks
Title
Number of falls during rehabilitation sessions
Description
Number of falls during rehabilitation sessions
Time Frame
An average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IIS Biocruces Bizkaia
City
Baracaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Applicability of the Device Belk in the Rehabilitation Process
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