Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment

Rehabilitation

General health

Online since 10 July 2024, updated 199 days ago

About this trial

This study is recruiting individuals with spinal cord injuries to test the Ekso Bionics powered exoskeleton device in a home setting. The robotic device powers lower extremities, enabling the movement of paralyzed legs. The study hopes to determine the practical use of the device in the home environment. The study requires a spotter (e.g. caregiver) to be trained and be present at all times the device is used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the user. Participants will receive the exoskeleton and the training needed for its use at home. The study time will be 12-36 months.

Included participants

Gender

All

Age

18 - 65 years

Injury level

C1 - S5

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

All

Injury type

Non-traumatic

Healthy volunteers

C1-S5

Additionally, participants must

have a body height between 152 and 193cm (5’-6’33 feet)

have a body weight of less than 100kg (<200 lbs)

have a prior experience or be willing to train on the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking. Participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures

What’s involved

Type

Rehabilitation

Details

Usage of the Ekso Bionic exoskeleton in the home setting for 12-36 months. Supervision of the usage by a trained spotter (caregiver). Outcome assessments throughout the 12-36 months.

Potential benefits

Main benefits

General health

Additional benefits

Bladder health/function

Bone health

Bowel health

Mental health and psychosocial factors

Pain

Skin health

Spasticity

Standing/walking/mobility

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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