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Clinical Applicability of the Device Belk in the Rehabilitation Process

Clinical Applicability of the Device Belk in the Rehabilitation Process

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04159623
Enrollment
20
Registered
2019-11-12
Start date
2020-11-10
Completion date
2021-04-08
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Application Site Atrophy

Brief summary

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

Interventions

DEVICEBelk Device

Knee exoskeleton with electrostimulation

Use the standard rehabilitative treatment

Sponsors

Basque Health Service
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of sessions until recoveryAn average of 12 weeksIt 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

MeasureTime frameDescription
March in 10 metersAn average of 12 weeksNumber of patients can be walk 10 meters
UP&Go testAn average of 12 weeksDo the UP&GO test
Number of falls during rehabilitation sessionsAn average of 12 weeksNumber of falls during rehabilitation sessions

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026