Skip to main content
OpenTrials
Completed

NCT Number: NCT04159623

Clinical Applicability of the Device Belk in the Rehabilitation Process

Pilot, interventional, randomized of parallel groups and multicenter clinical trial.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Application Site Atrophy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IIS Biocruces Bizkaia

Barakaldo, Bizkaia, 48903, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belk Device

Device

Knee exoskeleton with electrostimulation

Standard Rehabilitative treatment

Other

Use the standard rehabilitative treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. March in 10 meters

    Time frame: An average of 12 weeks

    Number of patients can be walk 10 meters

  2. UP&Go test

    Time frame: An average of 12 weeks

    Do the UP&GO test

  3. Number of falls during rehabilitation sessions

    Time frame: An average of 12 weeks

    Number of falls during rehabilitation sessions

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2019
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.