Clinical trial NCT05544409: MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention
Official title: Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: exoskeleton
total knee arthroplasty
rehabilitation
MAKv1
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Events
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: Auto-perceived Pain
timeFrame: Through completion of the use of the device, during 1 month
measure: Heart Rate
timeFrame: Through completion of the use of the device, during 1 month
measure: Blood pressure
timeFrame: Through completion of the use of the device, during 1 month
measure: Oxygen Saturation
timeFrame: Through completion of the use of the device, during 1 month
measure: Body Termperature
timeFrame: Through completion of the use of the device, during 1 month
measure: Repetitions per exercise
timeFrame: Through completion of the use of the device, during 1 month
measure: QUEST 2.0 scale
timeFrame: At the first month of the participation in the trial
measure: Range of Motion at the knee
timeFrame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
measure: Muscle strength at the knee
timeFrame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
measure: Knee circumference
timeFrame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
measure: Quadriceps circumference
timeFrame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
measure: 6MWT
timeFrame: Mesaured at the first month and at the second month (follow-up) from participation
measure: TUG
timeFrame: Mesaured at the first month and at the second month (follow-up) from participation
measure: FAC
timeFrame: Mesaured at the first month and at the second month (follow-up) from participation
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hozpital Universitario La Zarzuela
Study officials:
affiliation: Hospital Universitario Sanitas La Zarzuela
name: Ana Luisa López Morón
role: PRINCIPAL_INVESTIGATOR
References: