Debility Due to Disease
Conditions
Brief summary
A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.
Detailed description
Patients who are hospitalized for several weeks or months are at a higher risk of decline in physical condition and are also at a higher risk of rehospitalization within 30 days of discharge. A program incorporating robotic exoskeleton training may provide sufficient physical support and challenge for patients to maintain a higher level of physical condition than if they did not undergo exoskeleton training. The investigators aim to demonstrate that EksoGT robotic exoskeleton training can be performed safely with patients who have been hospitalized and are at risk of experiencing a further decline in their physical condition.
Interventions
DEVICEEksoGT with SmartAssist software
Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
Sponsors
Ekso Bionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm safety and feasibility study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of deconditioned, defined as the loss of muscle tone and endurance due to chronic disease, immobility, or loss of function. 2. Adults 18 years and older (or as specified by state law). 3. Admitted into a hospital, long-term care facility, skilled nursing facility, or similar. 4. 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). 5. Screened and cleared by a physician for full weight-bearing exercise training. 6. Weigh 220 pounds (100kg) or less. 7. Between approximately 5'0 and 6'4 tall. 8. Standing hip width of approximately 18 or less. 9. Have near normal range of motion in hips, knees and ankles.
Exclusion criteria
1. Currently involved in another intervention study. 2. Transferred to the intensive care unit or isolation-room stay. 3. Currently on a ventilator or extracorporeal membrane oxygenation (ECMO) machine. 4. Currently have a ventricular assist device (VAD) or an automatic implantable cardioverter-defibrillator (AICD). 5. Advanced heart failure - ejection fraction of \< 20%. 6. Documented cardiovascular risk from exercise. 7. Resting heart rate \<50 bpm or \>120 bpm. 8. Uncontrolled or new (within 24 hours) arrythmias. 9. Resting blood pressure below 90/70 or above 160/100. 10. Oxygen saturation (O2 sat) \< 90% during rest. 11. Uncontrolled or severe orthostatic hypotension that limits standing tolerance. 12. Cardiac ischemia within 24 hours. 13. Unresolved or new (within 24 hours) deep vein thrombosis. 14. Concurrent severe neurological pathology/disease or stroke within 72 hours. 15. Open skin ulcerations on any body surfaces in contact with exoskeleton. 16. Acute fracture 17. Osteoporosis 18. Active heterotrophic ossification (HO) of the lower extremity, hip dysplasia, or hip/knee axis abnormalities. 19. Current chemotherapy 20. Inability to speak or understand the English language. 21. Inability to cooperate in tests/exercises. 22. Hip flexion contracture greater than \ 17°. 23. Knee flexion contracture greater than 12°. 24. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion). 25. Cognitive impairments - unable to follow 2 step commands or to communicate pain or to stop session. 26. Pregnancy 27. Any reason the physician may deem as harmful to the participant to enroll or continue in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event During Time of Treatment | 2 weeks | The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed Definitely Device Related | 2 weeks | Count of number of participants who experienced any adverse event that was rated as definitely related to treatment with the Ekso device. |
Countries
United States
Participant flow
Pre-assignment details
One arm study.
Participants by arm
| Arm | Count |
|---|---|
| Interventional Group All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
EksoGT with SmartAssist software: Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Interventional Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 50.87 years STANDARD_DEVIATION 19.94 |
| Days since diagnosis | 93.62 days STANDARD_DEVIATION 75.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 5 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Participants Who Experience an Adverse Event During Time of Treatment
The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period.
Time frame: 2 weeks
Population: 2 participants did not complete study protocol due to early discharge from hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Group | Number of Participants Who Experience an Adverse Event During Time of Treatment | 5 Participants |
Secondary
Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed Definitely Device Related
Count of number of participants who experienced any adverse event that was rated as definitely related to treatment with the Ekso device.
Time frame: 2 weeks
Population: 2 participants did not complete study protocol due to early discharge from hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Group | Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed Definitely Device Related | 2 Participants |