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

NCT ID: NCT05544409

Last Updated: 2022-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2021-02-08

Brief Summary

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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

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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

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Total Knee Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MAKv1

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

Group Type EXPERIMENTAL

MAKv1

Intervention Type DEVICE

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

Interventions

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MAKv1

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MarsiBionics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Luisa López Morón

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Sanitas La Zarzuela

Locations

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Hozpital Universitario La Zarzuela

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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TKA_MAK

Identifier Type: -

Identifier Source: org_study_id

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