Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation

Spinal Cord Injuries Clinical Trial

Official title:

Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013997
• Other study ID #: GCO 15-2253
• Status: Completed
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: July 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Inpatients
• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	The Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

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