NCT05544409

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

Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: MarsiBionics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	MAKv1	1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month

Timeline

• Start date: 2019-06-12
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2022-09-16
• Last updated: 2022-09-16

Locations

1 site across 1 country: Spain