MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention

Marsi Bionics

Status: Completed

Conditions: Total Knee Arthroplasty

Treatments: Device: MAKv1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05544409

TKA_MAK

Details and patient eligibility

About

The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA). Safety, usability and clinical effects of an early intervention program with the device with an early implementation are studied.

Full description

The present study will analyze the safety, usability and clinical effects of using the MAKv1 exoskeleton in TKA patients. The intervention will consist of 1 hour sessions with the MAKv1 device, thrice per week during 1 month. Safety measurements (serious adverse events, vitals, and auto-perceived pain) will be collected at each session with the device, along with the repetitions performed at each exercise assisted with the device. After the first week is completed, measurements regarding clinical effect will be collected. Also, at the end of the month were the participants receive the sessions with the device, clinical effects will be measured again, along with a questionnaire to collect the users' perception of the device (QUEST 2.0).

Enrollment: 6 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing TKA surgery

Exclusion criteria

• inability to understand simple instructions
• postoperative complications that may be a risk to use the exoskeleton
• other conditions that prevented mobilisation in early stages after TKA
• weight > 100 kg
• size < 150 cm
• size > 190 cm

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

MAKv1

Experimental group

Description:

The MAKv1 group will receive 1 hour of MAKv1 rehabilitation, thrice per week during 1 month

Treatment:

Device: MAKv1