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Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries Inpatients | Device: EksoGT | Not Applicable |
Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitation, if they helped people to walk better than with traditional locomotor training methods, or if they had any other effects (better or worse) on recovery.
The study team's objectives of this study were to explore the safety, feasibility, and efficacy of using the powered exoskeleton, EksoGT, to provide a locomotor training intervention in acute inpatient rehabilitation for persons with spinal cord injury (SCI) who were eligible for locomotor training.
Aim 1 examined the safety of exoskeleton use for persons with SCI during inpatient rehabilitation. Measures for this aim analyzed the amount of falls as well as types and counts of other adverse events (AE) for both serious and non-serious events as outlined by the FDA.
Aim 2 helped determine the feasibility of exoskeleton use during inpatient rehabilitation for SCI by monitoring the time from admission to first stand in the device, accumulated step count/time in the device, and progression of locomotor training frequency, duration, and intensity.
Aim 3 explored the potential for associations between exoskeleton use in inpatient rehabilitation and body functions and activities associated with walking. Measures for this aim included: American Spinal Injury Association (ASIA) Impairment Scale (AIS), Neurological Level of Injury (NLI), Upper and Lower Extremity Motor Scores, and Functional Index Measure (FIM).
Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians would identify patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants.
After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determines it is safe for participants to begin standing, and continued until the participant is discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living (functioning) compared to the matched control group who didn't have Ekso training and were chosen by a retrospective chart review.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living compared to matched control group who didn't have Ekso training chosen from retrospective chart review. |
| Masking: | None (Open Label) |
| Primary Purpose: | Device Feasibility |
| Official Title: | Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation |
| Actual Study Start Date : | August 11, 2017 |
| Actual Primary Completion Date : | June 12, 2018 |
| Actual Study Completion Date : | June 12, 2018 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Exoskeletal-assisted walking training group
Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study.
|
Device: EksoGT
The intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation.
Other Name: Exoskeletal-assisted walking training
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No Intervention: Matched control group
Twenty inpatients with SCI were identified as the matched control group through reviewing an acute inpatient rehabilitation database of Uniform Data System for Medical Rehabilitation by a person blinded to the study. The control group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. The control groups received the same amount of acute rehabilitation time per week as the intervention group. |
- Number of fall [ Time Frame: 2 years ]Number of falls to assess safety
- Number of adverse events [ Time Frame: 2 years ]types and counts of the adverse events for both serious and non-serious events as outlined by the FDA to assess safety
- The time from admission to first stand in the device [ Time Frame: 2 years ]The days between admission date and the date of first stand in the device
- Accumulated step count in the device [ Time Frame: 2 years ]The total steps count during the exoskeletal-assisted walking (EAW) training in the acute inpatient rehabilitation
- Accumulated step time in the device [ Time Frame: 2 years ]The total walking time during the EAW training in the acute inpatient rehabilitation
- Proportion of walking time [ Time Frame: 2 years ]The change of the proportion of walking time in the device (proportion of walking time = walking time/total time in the device)
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) [ Time Frame: 2 years ]
A: Complete - No motor or sensory function is preserved in the sacral segments S4-S5.
B: Incomplete - Sensory function preserved but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.
C: Incomplete - Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.
D: Incomplete - Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.
E: Normal - Motor and sensory function are normal.
- Neurological Level of Injury (NLI) [ Time Frame: 2 years ]The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body
- Upper Extremity Motor Scores (UEMS) [ Time Frame: 2 years ]Total score from 0-50, with higher score indicating better outcomes
- Lower Extremity Motor Scores (LEMS) [ Time Frame: 2 years ]Total score from 0-50, with higher score indicating better outcomes
- Functional Independence Measure (FIM) [ Time Frame: 2 years ]The FIM is an 18-item instrument, total score range from 18-126, with higher score indicating higher level of function
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years or greater
- Height between 5'2" and 6'2" (1.6 meters to 1.9 meters)
- Weight less than 220 pounds (100 kilograms)
- Near Normal range of motion (ROM), as follows:
- Hip: 5 degrees of extension; 110 of flexion
- Knee: Full extension to 110 of flexion
- Ankle: at least 0 of dorsiflexion to 25 of plantarflexion
- Are eligible for locomotor training as part of inpatient rehabilitation
- Independent with static sitting balance
- Sufficient function upper extremity strength to manage walking aid (front-wheeled walker, platform walker, or crutches)
- Able to follow directions
Exclusion Criteria:
- Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
- Inability to stand upright due to orthostatic hypotension
- Body characteristics that do not fit within exoskeleton limits
- Upper leg length discrepancy > 0.5" or lower leg discrepancy >0.75"
- Skin integrity issues in areas that would contact the device or that would likely be made worse by device use
- Pregnancy
- Colostomy
- Non-English Speaking
- The participant is able to walk better with exoskeleton assistance at baseline
- Any other issue that might prevent safe standing or walking
| United States, New York | |
| The Mount Sinai Hospital | |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Miguel X Escalon, MD | Icahn School of Medicine at Mount Sinai |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 8, 2019 | ||||
| First Posted Date ICMJE | July 10, 2019 | ||||
| Last Update Posted Date | July 10, 2019 | ||||
| Actual Study Start Date ICMJE | August 11, 2017 | ||||
| Actual Primary Completion Date | June 12, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation | ||||
| Official Title ICMJE | Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation | ||||
| Brief Summary | To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other effects (better or worse) on recovery. | ||||
| Detailed Description |
Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitation, if they helped people to walk better than with traditional locomotor training methods, or if they had any other effects (better or worse) on recovery. The study team's objectives of this study were to explore the safety, feasibility, and efficacy of using the powered exoskeleton, EksoGT, to provide a locomotor training intervention in acute inpatient rehabilitation for persons with spinal cord injury (SCI) who were eligible for locomotor training. Aim 1 examined the safety of exoskeleton use for persons with SCI during inpatient rehabilitation. Measures for this aim analyzed the amount of falls as well as types and counts of other adverse events (AE) for both serious and non-serious events as outlined by the FDA. Aim 2 helped determine the feasibility of exoskeleton use during inpatient rehabilitation for SCI by monitoring the time from admission to first stand in the device, accumulated step count/time in the device, and progression of locomotor training frequency, duration, and intensity. Aim 3 explored the potential for associations between exoskeleton use in inpatient rehabilitation and body functions and activities associated with walking. Measures for this aim included: American Spinal Injury Association (ASIA) Impairment Scale (AIS), Neurological Level of Injury (NLI), Upper and Lower Extremity Motor Scores, and Functional Index Measure (FIM). Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians would identify patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determines it is safe for participants to begin standing, and continued until the participant is discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living (functioning) compared to the matched control group who didn't have Ekso training and were chosen by a retrospective chart review. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study. Consent forms were given to prospected participants. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation. The study team monitored participants for adverse events (safety), tracked the amount of walking provided during the inpatient stay (feasibility), and explored the improvement of activities of daily living compared to matched control group who didn't have Ekso training chosen from retrospective chart review. Masking: None (Open Label)Primary Purpose: Device Feasibility |
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| Condition ICMJE |
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| Intervention ICMJE | Device: EksoGT
The intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation.
Other Name: Exoskeletal-assisted walking training
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
10 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 12, 2018 | ||||
| Actual Primary Completion Date | June 12, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04013997 | ||||
| Other Study ID Numbers ICMJE | GCO 15-2253 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Miguel Escalon, Icahn School of Medicine at Mount Sinai | ||||
| Study Sponsor ICMJE | Icahn School of Medicine at Mount Sinai | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Icahn School of Medicine at Mount Sinai | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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