About this trial
Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Traumatic or non-traumatic SCI ≥6 months duration of SCI;
Wheelchair-user for indoor and outdoor mobility;
Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);
Able to hold the crutches in hands with or without modifications; and
Disqualifiers
Diagnosis of neurological injury other than SCI;
Progressive condition that would be expected to result in changing neurological status;
Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
Anthropocentric incompatibility to be fitted with the device;
Trial design
Single group
Treatments tested in this trial
Indego™ Exoskeleton
DeviceThe Indego® is a powered exoskeleton that can be used as a mode of therapy in an institutional setting. Proper walking in this device requires the user to manipulate their center of gravity and balance by postural trunk excursions in order for the legs to take steps.
Treatment groups
Trial outcomes
Primary outcomes
Seated Computerized Dynamic Posturography (sCDP)
Seated balance will be measured by assessment of the limits of stability (LOS) using computerized dynamic posturography (SMART EquiTest, Natus). The SMART EquiTest® system utilizes a dynamic force plate to quantify the vertical forces exerted through the participant's center of gravity as s/he sits on a cushioned block with back unsupported and arms crossed over the clavicles.
Secondary outcomes
Seated Activities of Daily Living (ADLs)
Participants' seated ADLs will be assessed by self-reported Spinal Cord Independence Measure (SCIM) and Spinal Cord Injury - Functional Index (SCI-FI, short forms). Participants' functional performance of ADLs will be assessed using the timed t-shirt dressing test by a study team member.
Motor Evoked Potentials (MEPs)
Leg muscles will be used to assess neuroplastic changes between the motor cortex and descending neural pathways below incomplete spinal lesions.
Other outcomes
Spinal Cord Independence Measure (SCIM)
The SCIM is a clinical tool to evaluate the independent performance of ADL especially for people with SCI.
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