Clinical trial NCT04013997: Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
Official title: Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Inpatients
Keywords: Rehabilitation
Walking
Equipment and Supplies
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of fall
timeFrame: 2 years
measure: Number of adverse events
timeFrame: 2 years
Secondary outcomes:
measure: The time from admission to first stand in the device
timeFrame: 2 years
measure: Accumulated step count in the device
timeFrame: 2 years
measure: Accumulated step time in the device
timeFrame: 2 years
measure: Proportion of walking time
timeFrame: 2 years
measure: American Spinal Injury Association (ASIA) Impairment Scale (AIS)
timeFrame: 2 years
measure: Neurological Level of Injury (NLI)
timeFrame: 2 years
measure: Upper Extremity Motor Scores (UEMS)
timeFrame: 2 years
measure: Lower Extremity Motor Scores (LEMS)
timeFrame: 2 years
measure: Functional Independence Measure (FIM)
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Miguel X Escalon, MD
role: PRINCIPAL_INVESTIGATOR
References: