Seated Balance Using the Indego™

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJames J. Peters Veterans Affairs Medical Center

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 volunteers

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

Design model

Single group

Treatments tested in this trial

  • Indego™ Exoskeleton

    Device

    The 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

20 Participants
are divided into 1 treatment group
Group A: Exoskeleton UsersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline after 8 weeks and after 12 weeks.

Secondary outcomes

1

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.

Time frame
Change from baseline after 8 weeks and after 12 weeks.
2

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.

Time frame
Change from baseline after 8 weeks and after 12 weeks.

Other outcomes

1

Spinal Cord Independence Measure (SCIM)

The SCIM is a clinical tool to evaluate the independent performance of ADL especially for people with SCI.

Time frame
Change from baseline after 8 weeks and after 12 weeks.

Sponsors and contacts

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