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Seated Balance Using the Indego™

Primary Purpose

Spinal Cord Injuries

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Indego™ Exoskeleton

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
History of seizure;
Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
History of stroke, brain tumor, brain abscess, or multiple sclerosis;
History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
Pregnancy or women who plan to become pregnant during the study period.

Sites / Locations

James J. Peters VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exoskeleton Users

Arm Description

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.

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

NCT ID

NCT04047992

First Posted

May 15, 2018

Last Updated

September 26, 2023

Sponsor

James J. Peters Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04047992

Brief Title

Seated Balance Using the Indego™

Official Title

"The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

James J. Peters Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Introduction/Background: People with spinal cord injury (SCI) can lose partial to complete voluntary control of arm, trunk and leg muscles, resulting in an inability to sit with stability, stand and/or walk. Because of poor trunk control during sitting, it may be challenging to reach for objects, dress or transfer independently, and the risk of a fall from their wheelchair is increased. Exoskeleton-assisted walking (EAW) provides upright, over ground mobility and has been demonstrated to be beneficial to improve patient-reported quality of life and some health-related outcomes. However, present day exoskeletons are not ready to replace the wheelchair. Our preliminary findings suggest that while walking in an exoskeleton, people with SCI are challenged to maintain upright balance by using their trunk muscles in a way that is rarely done from a wheelchair. Stimulation of the trunk muscles from upright postural challenges during EAW appears to benefit overall seated trunk control. Summary of Goals and Objectives: The purpose of this study is to determine whether EAW can improve the primary outcomes of: seated balance, seated activities of daily living, and trunk muscle use. Additional secondary outcomes for body composition will be studied. Twenty people with SCI (T4 and below) who are wheelchair users will be recruited to participate. Impact: The investigators believe that EAW training will significantly improve seated balance to improve wheelchair safety, stability and quality of life, thus, empowering people with SCI who use a wheelchair to live more independently. If EAW is demonstrated to have a significant benefit on seated balance, then use of these devices in the clinical and home environments may be further justified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exoskeleton Users

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Indego™ Exoskeleton

Intervention Description

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.

Primary Outcome Measure Information:

Title

Seated Computerized Dynamic Posturography (sCDP)

Description

Time Frame

Change from baseline after 8 weeks and after 12 weeks.

Secondary Outcome Measure Information:

Title

Seated Activities of Daily Living (ADLs)

Description

Time Frame

Change from baseline after 8 weeks and after 12 weeks.

Title

Motor Evoked Potentials (MEPs)

Description

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 Pre-specified Outcome Measures:

Title

Spinal Cord Independence Measure (SCIM)

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; History of seizure; Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion; History of stroke, brain tumor, brain abscess, or multiple sclerosis; History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging); History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator; Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or Pregnancy or women who plan to become pregnant during the study period.

Facility Information:

Facility Name

James J. Peters VA Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10468

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Knezevic, MS

Phone

718-584-9000

Ext

3130

Steven.Knezevic@va.gov

First Name & Middle Initial & Last Name & Degree

Pierre K Asselin, MS

Phone

718-584-9000

Ext

3124

Pierre.Asselin@va.gov

First Name & Middle Initial & Last Name & Degree

Annn M Spungen, EdD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Seated Balance Using the Indego™

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