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
Qualifiers
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
Treatments tested in this trial
- Indego™ Exoskeleton