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Total Knee ArthroplastyNCT05544409

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

A study testing MAKv1 in people with Total Knee Arthroplasty, run by MarsiBionics at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
MAKv1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSpain
Study dates
12 Jun 2019to 8 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients undergoing TKA surgery

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Hozpital Universitario La Zarzuela

    Madrid, 28023

Other trials in Spain

About this study

Official title: Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation

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.

Read the 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).

Being tested
MAKv1
Keywords
exoskeleton, total knee arthroplasty, rehabilitation, MAKv1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAKv1Device

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

Study groups in NCT05544409
Study groupRoleWhat they receive
MAKv1ExperimentalThe MAKv1 group will receive 1 hour of MAKv1 rehabilitation, thrice per week during 1 month
Receives: Device: MAKv1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events

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

    Measured: Through study completion, an average of 2 months

Secondary outcomes (14)

  1. Auto-perceived Pain

    Presence of pain collected with VAS scale (0 to 10)

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

  2. Heart Rate

    Differences in heart rate beofre and after the use of the device (measured in beats/min)

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

  3. Blood pressure

    Differences in blood pressure before and after the use of the device (measured in mmHg)

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

  4. Oxygen Saturation

    Differences in oxygen satruation before and after the use of the device (measured in %SpO2)

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

  5. Body Termperature

    Differences in body temperature before and after the use of the device (measured in celsius)

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

  6. Repetitions per exercise

    The number of repetitions per exercise assissted by the MAKv1 device was recorded (mesaured in number of repetitions)

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

  7. QUEST 2.0 scale

    QUEST 2.0 scale is a usability scale which rates the perception of the user about the device.

    Measured: At the first month of the participation in the trial

  8. Range of Motion at the knee

    Range of motion of the knee, measured in degrees (º).

    Measured: Mesaured at the first week, at the first month and at the second month (follow-up) from participation

  9. Muscle strength at the knee

    Muscle strength of knee muscles, measured by the modified Medical Research Council scale (mMRC).

    Measured: Mesaured at the first week, at the first month and at the second month (follow-up) from participation

  10. Knee circumference

    Circumference of the knee, measured with a metric tape placed at the upper border of the patella (measured in cm)

    Measured: Mesaured at the first week, at the first month and at the second month (follow-up) from participation

  11. Quadriceps circumference

    Circumference of the quadriceps, measured with a metric tape placed at 10 cm from the upper border of the patella (measured in cm)

    Measured: Mesaured at the first week, at the first month and at the second month (follow-up) from participation

  12. 6MWT

    6MWT consists of a test were the subject is asked to walk for 6 minutes and the distance covered is collected (measured in meters)

    Measured: Mesaured at the first month and at the second month (follow-up) from participation

  13. TUG

    The Timed Up and Go test consists of a test were the subject is asked to stand up from a chair, cover 3 meters in a straight line, and then go back to sit in the same chair. Time to complete the task is recorded (measured in seconds)

    Measured: Mesaured at the first month and at the second month (follow-up) from participation

  14. FAC

    The functional Ambulation Categories scale measures the patient's ability according to the assistance needed to deambulate. A score is given from 0 to 5.

    Measured: Mesaured at the first month and at the second month (follow-up) from participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start12 Jun 2019
  3. Primary completion8 Feb 2021
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544409
Sponsor's protocol ID
TKA_MAK
Status last verified
Sep 2022
First submitted
12 Sep 2022
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be anonymized in order to avoid pariticpant's identification

Questions about this trial

What is this clinical trial studying?

A study testing MAKv1 in people with Total Knee Arthroplasty, run by MarsiBionics at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05544409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

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