Spinal Cord Injuries Clinical Trial
Official title:
Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
Verified date | July 2019 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 12, 2018 |
Est. primary completion date | June 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of fall | Number of falls to assess safety | 2 years | |
Primary | Number of adverse events | types and counts of the adverse events for both serious and non-serious events as outlined by the FDA to assess safety | 2 years | |
Secondary | The time from admission to first stand in the device | The days between admission date and the date of first stand in the device | 2 years | |
Secondary | Accumulated step count in the device | The total steps count during the exoskeletal-assisted walking (EAW) training in the acute inpatient rehabilitation | 2 years | |
Secondary | Accumulated step time in the device | The total walking time during the EAW training in the acute inpatient rehabilitation | 2 years | |
Secondary | Proportion of walking time | The change of the proportion of walking time in the device (proportion of walking time = walking time/total time in the device) | 2 years | |
Secondary | American Spinal Injury Association (ASIA) Impairment Scale (AIS) | 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. |
2 years | |
Secondary | Neurological Level of Injury (NLI) | 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 | 2 years | |
Secondary | Upper Extremity Motor Scores (UEMS) | Total score from 0-50, with higher score indicating better outcomes | 2 years | |
Secondary | Lower Extremity Motor Scores (LEMS) | Total score from 0-50, with higher score indicating better outcomes | 2 years | |
Secondary | Functional Independence Measure (FIM) | The FIM is an 18-item instrument, total score range from 18-126, with higher score indicating higher level of function | 2 years |
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