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

NCT05544409 | Completed

• 1 other identifier: TKA_MAK
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

exoskeleton; total knee arthroplasty; rehabilitation; MAKv1

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events

  event that causes death, life-threat, hospitalization, disability, congenital anomaly, or that requires intervention to prevent permanent impairment or damage

  Through study completion, an average of 2 months

Secondary Outcomes (14)

• Auto-perceived Pain

  Through completion of the use of the device, during 1 month

• Heart Rate

  Through completion of the use of the device, during 1 month

• Blood pressure

  Through completion of the use of the device, during 1 month

• Oxygen Saturation

  Through completion of the use of the device, during 1 month

• Body Termperature

  Through completion of the use of the device, during 1 month

Study Arms (1)

MAKv1

EXPERIMENTAL

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

Device: MAKv1

Interventions

MAKv1 DEVICE

1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month

MAKv1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing TKA surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• MarsiBionics: lead

Study Sites (1)

Hozpital Universitario La Zarzuela

Madrid, 28023, Spain

Location

Study Officials

• Ana Luisa López Morón

  Hospital Universitario Sanitas La Zarzuela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 16, 2022
• Study Start: June 12, 2019
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)