N/A
N=15
Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Debility Due to Disease
Bottom Line
View on ClinicalTrials.gov: NCT03355755 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants Who Experience an Adverse Event During Time of Treatment — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EksoGT with SmartAssist software (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ekso Bionics
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience an Adverse Event During Time of Treatment |
5 | — |
| SECONDARY Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed "Definitely Device Related" |
2 | — |
Summary
A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of "deconditioned", defined as the loss of muscle tone and endurance due to chronic disease, immobility, or loss of function.
- Adults 18 years and older (or as specified by state law).
- Admitted into a hospital, long-term care facility, skilled nursing facility, or similar.
- Sufficient upper extremity strength to use a front wheeled walker by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction and flexion/extension 4/5).
- Screened and cleared by a physician for full weight-bearing exercise training.
- Weigh 220 pounds (100kg) or less.
- Between approximately 5'0" and 6'4" tall.
- Standing hip width of approximately 18" or less.
- Have near normal range of motion in hips, knees and ankles.
Exclusion Criteria
- Currently involved in another intervention study.
- Transferred to the intensive care unit or isolation-room stay.
- Currently on a ventilator or extracorporeal membrane oxygenation (ECMO) machine.
- Currently have a ventricular assist device (VAD) or an automatic implantable cardioverter-defibrillator (AICD).
- Advanced heart failure - ejection fraction of 120 bpm.
- Uncontrolled or new (within 24 hours) arrythmias.
- Resting blood pressure below 90/70 or above 160/100.
- Oxygen saturation (O2 sat) < 90% during rest.
- Uncontrolled or severe orthostatic hypotension that limits standing tolerance.
- Cardiac ischemia within 24 hours.
- Unresolved or new (within 24 hours) deep vein thrombosis.
- Concurrent severe neurological pathology/disease or stroke within 72 hours.
- Open skin ulcerations on any body surfaces in contact with exoskeleton.
- Acute fracture
- Osteoporosis
- Active heterotrophic ossification (HO) of the lower extremity, hip dysplasia, or hip/knee axis abnormalities.
- Current chemotherapy
- Inability to speak or understand the English language.
- Inability to cooperate in tests/exercises.
- Hip flexion contracture greater than ~17°.
- Knee flexion contracture greater than 12°.
- Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion).
- Cognitive impairments - unable to follow 2 step commands or to communicate pain or to stop session.
- Pregnancy
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study.
Data sourced from ClinicalTrials.gov (NCT03355755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.