Clinical Applicability of the Device Belk in the Rehabilitation Process

Application Site Atrophy Clinical Trial

Official title:

Clinical Applicability of the Device Belk in the Rehabilitation Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159623
• Other study ID #: Belk
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: May 2021
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Application Site Atrophy
• Atrophy

Intervention

Device:
• Belk Device
Knee exoskeleton with electrostimulation

Other:
• Standard Rehabilitative treatment
Use the standard rehabilitative treatment

Locations

Country	Name	City	State
Spain	IIS Biocruces Bizkaia	Baracaldo	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

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