Clinical Applicability of the Device Belk in the Rehabilitation Process

May 28, 2021 updated by: Juan Andrés Álava, Basque Health Service
Pilot, interventional, randomized of parallel groups and multicenter clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Bizkaia
      • Baracaldo, Bizkaia, Spain, 48903
        • IIS Biocruces Bizkaia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belk Device
With Belk Device
Device: Belk Device
Knee exoskeleton with electrostimulation
Other: Standard Rehabilitative treatment
With the standard rehabilitative treatment
Other: Standard Rehabilitative treatment
Use the standard rehabilitative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sessions until recovery
Time Frame: 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.
An average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
March in 10 meters
Time Frame: An average of 12 weeks
Number of patients can be walk 10 meters
An average of 12 weeks
UP&Go test
Time Frame: An average of 12 weeks
Do the UP&GO test
An average of 12 weeks
Number of falls during rehabilitation sessions
Time Frame: An average of 12 weeks
Number of falls during rehabilitation sessions
An average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2020

Primary Completion (Actual)

April 8, 2021

Study Completion (Actual)

April 8, 2021

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Belk

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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