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Completed

NCT Number: NCT05544409

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

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hozpital Universitario La Zarzuela

Madrid, 28023, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAKv1

Device

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

Primary outcomes

  1. Serious Adverse Events

    Time frame: Through study completion, an average of 2 months

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

Secondary outcomes

  1. Auto-perceived Pain

    Time frame: Through completion of the use of the device, during 1 month

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

  2. Heart Rate

    Time frame: Through completion of the use of the device, during 1 month

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

  3. Blood pressure

    Time frame: Through completion of the use of the device, during 1 month

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

  4. Oxygen Saturation

    Time frame: Through completion of the use of the device, during 1 month

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

  5. Body Termperature

    Time frame: Through completion of the use of the device, during 1 month

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

  6. Repetitions per exercise

    Time frame: Through completion of the use of the device, during 1 month

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

  7. QUEST 2.0 scale

    Time frame: At the first month of the participation in the trial

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

  8. Range of Motion at the knee

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

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

  9. Muscle strength at the knee

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

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

  10. Knee circumference

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

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

  11. Quadriceps circumference

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

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

  12. 6MWT

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

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

  13. TUG

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

    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)

  14. FAC

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

    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.

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Registry information

Official study title

Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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