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A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EksoGT with SmartAssist software | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaylord Specialty Healthcare | Wallingford | Connecticut | 06492 | United States | ||
| Marianjoy Rehabilitation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16084819 | Background | Thomas JI, Lane JV. A pilot study to explore the predictive validity of 4 measures of falls risk in frail elderly patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1636-40. doi: 10.1016/j.apmr.2005.03.004. | |
| 23810355 | Background | Hoyer EH, Needham DM, Miller J, Deutschendorf A, Friedman M, Brotman DJ. Functional status impairment is associated with unplanned readmissions. Arch Phys Med Rehabil. 2013 Oct;94(10):1951-8. doi: 10.1016/j.apmr.2013.05.028. Epub 2013 Jun 26. |
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One arm study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 2 participants did not complete study protocol due to early discharge from hospital | Posted | Count of Participants | Participants | 2 weeks |
|
Adverse events were taken through the duration of the study (completing 5 sessions in exoskeleton) which took, on average, 12 days to complete.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | fall | Systematic Assessment | Three participants experienced single fall in which no injuries were documented and no medical treatment was necessary |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Van Hiel | Ekso Bionics | 4042268017 | leslie.vanhiel@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2017 | Mar 22, 2023 | Prot_001.pdf |
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Single-arm safety and feasibility study.
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|
| Wheaton |
| Illinois |
| 60187 |
| United States |
| Quality Living, Inc | Omaha | Nebraska | 68104 | United States |
| 24616216 | Background | Hoyer EH, Needham DM, Atanelov L, Knox B, Friedman M, Brotman DJ. Association of impaired functional status at hospital discharge and subsequent rehospitalization. J Hosp Med. 2014 May;9(5):277-82. doi: 10.1002/jhm.2152. Epub 2014 Feb 26. |
| 25133615 | Background | Hoyer EH, Brotman DJ, Chan KS, Needham DM. Barriers to early mobility of hospitalized general medicine patients: survey development and results. Am J Phys Med Rehabil. 2015 Apr;94(4):304-12. doi: 10.1097/PHM.0000000000000185. |
| 26849277 | Background | Hoyer EH, Friedman M, Lavezza A, Wagner-Kosmakos K, Lewis-Cherry R, Skolnik JL, Byers SP, Atanelov L, Colantuoni E, Brotman DJ, Needham DM. Promoting mobility and reducing length of stay in hospitalized general medicine patients: A quality-improvement project. J Hosp Med. 2016 May;11(5):341-7. doi: 10.1002/jhm.2546. Epub 2016 Feb 5. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Days since diagnosis | From study initiation, how many days prior had patient been diagnosed with deconditioning | One participants date of diagnosis was unknown and not analyzed | Mean | Standard Deviation | days |
|
|
|
| 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. | 2 participants did not complete study protocol due to early discharge from hospital | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 5 |
| 13 |
|
| skin tear and pressure sores | Skin and subcutaneous tissue disorders | skin | Systematic Assessment | one participant experienced a consistent pressure ulcer session 1-4. Another participant experienced a minor right posterior thigh skin tear requiring no medical intervention |
|
| Spasm | Nervous system disorders | spasm | Systematic Assessment | One participant experienced an increase in nightime spasm |
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| Swelling and erythema | Skin and subcutaneous tissue disorders | Swelling | Systematic Assessment | One participant experienced a single episode of leg swelling and erythema on anterior shins both categorized as mild |
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