NCT04159623

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

November 6, 2019

Last Update Submit

May 28, 2021

Conditions

Application Site Atrophy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • March in 10 meters

    An average of 12 weeks

  • UP&Go test

    An average of 12 weeks

  • Number of falls during rehabilitation sessions

    An average of 12 weeks

Study Arms (2)

Belk Device

EXPERIMENTAL

With Belk Device

Device: Belk Device

Standard Rehabilitative treatment

OTHER

With the standard rehabilitative treatment

Other: Standard Rehabilitative treatment

Interventions

Belk DeviceDEVICE

Knee exoskeleton with electrostimulation

Belk Device
Standard Rehabilitative treatmentOTHER

Use the standard rehabilitative treatment

Standard Rehabilitative treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes.
  • Patients aged between 18 and 85 years.
  • Patients with knee arthroplasty in the immediate postoperative period.
  • Sign in informed consent.

You may not qualify if:

  • Physical or psychological pathologies that prevent patient participation.
  • Tumor arthroplasty.
  • Knee replacement prosthesis.
  • Impossibility of holding the device.
  • Patients with a pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IIS Biocruces Bizkaia

Barakaldo, Bizkaia, 48903, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 12, 2019

Study Start

November 10, 2020

Primary Completion

April 8, 2021

Study Completion

April 8, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations

ES(1)