Seated Balance Using the Indego™

NCT04047992 | Recruiting DMC FDA Device

• 1 other identifier: SPU-17-029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

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.

  Change from baseline after 8 weeks and after 12 weeks.

Secondary Outcomes (2)

• Seated Activities of Daily Living (ADLs)

  Change from baseline after 8 weeks and after 12 weeks.

• Motor Evoked Potentials (MEPs)

  Change from baseline after 8 weeks and after 12 weeks.

Other Outcomes (1)

• Spinal Cord Independence Measure (SCIM)

  Change from baseline after 8 weeks and after 12 weeks.

Study Arms (1)

Exoskeleton Users

EXPERIMENTAL

All participants will receive 36 sessions of supervised EAW training using Indego™ for 12 weeks (3 to 4 sessions per week, 4-6 hours per week). The goal is to complete all 36 sessions in 12 weeks, but allowing for a two-week carryover to accommodate schedule conflicts or missed sessions.

Device: Indego™ Exoskeleton

Interventions

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.

Exoskeleton Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to provide informed consent.

You may not qualify if:

• 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;
• Traumatic or high impact lower extremity fracture within the past 2 years;
• Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
• Knee BMD \< 0.60 gm/cm2;
• Total hip BMD T-scores \< -3.5;
• Untreatable severe spasticity judged to be contraindicated by the Site Physician;
• Flexion contracture that is incompatible with the device;
• Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
• Fracture of the foot by x-ray and confirmed by CT;
• Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg);
• Unresolved orthostatic hypotension (systolic blood pressure \<90 mmHg; diastolic blood pressure \<60 mmHg) as judged to be contraindicated by the Site Physician;
• Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, VA RR&D National Center for the Medical Consequences of Spinal Cord Injury

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: August 7, 2019
• Study Start: February 1, 2018
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)