Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Serious Adverse Events
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MAKv1
The MAKv1 group will receive 1 hour of MAKv1 rehabilitation, thrice per week during 1 month
Intervention: MAKv1 (Device)
Outcomes
Primary Outcomes
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
- Auto-perceived Pain(Through completion of the use of the device, during 1 month)
- Blood pressure(Through completion of the use of the device, during 1 month)
- Muscle strength at the knee(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Knee circumference(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Quadriceps circumference(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- 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)
- TUG(Mesaured at the first month and at the second month (follow-up) from participation)
- FAC(Mesaured at the first month and at the second month (follow-up) from participation)
- Heart Rate(Through completion of the use of the device, during 1 month)
- Range of Motion at the knee(Mesaured at the first week, at the first month and at the second month (follow-up) from participation)
- Repetitions per exercise(Through completion of the use of the device, during 1 month)
- QUEST 2.0 scale(At the first month of the participation in the trial)
- 6MWT(Mesaured at the first month and at the second month (follow-up) from participation)