- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04047992
Seated Balance Using the Indego™
"The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10468
- Recruiting
- James J. Peters VA Medical Center
-
Contact:
- Steven Knezevic, MS
- Phone Number: 3130 718-584-9000
- Email: Steven.Knezevic@va.gov
-
Principal Investigator:
- Annn M Spungen, EdD
-
Contact:
- Pierre K Asselin, MS
- Phone Number: 3124 718-584-9000
- Email: Pierre.Asselin@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exoskeleton Users
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seated Computerized Dynamic Posturography (sCDP)
Time Frame: Change from baseline after 8 weeks and after 12 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seated Activities of Daily Living (ADLs)
Time Frame: Change from baseline after 8 weeks and after 12 weeks.
|
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.
|
Change from baseline after 8 weeks and after 12 weeks.
|
Motor Evoked Potentials (MEPs)
Time Frame: Change from baseline after 8 weeks and after 12 weeks.
|
Leg muscles will be used to assess neuroplastic changes between the motor cortex and descending neural pathways below incomplete spinal lesions.
|
Change from baseline after 8 weeks and after 12 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal Cord Independence Measure (SCIM)
Time Frame: Change from baseline after 8 weeks and after 12 weeks.
|
The SCIM is a clinical tool to evaluate the independent performance of ADL especially for people with SCI.
|
Change from baseline after 8 weeks and after 12 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPU-17-029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
-
M.D. Anderson Cancer CenterActive, not recruitingMetastatic Epidural Spinal Cord CompressionUnited States
Clinical Trials on Indego™ Exoskeleton
-
Vanderbilt UniversityCompletedSpinal Cord InjuryUnited States
-
Vanderbilt UniversityWithdrawnSpinal Cord InjuryUnited States
-
Parker Hannifin CorporationCedars-Sinai Medical Center; Kessler Foundation; TIRR Memorial Hermann; Shirley... and other collaboratorsCompletedStroke | Hemiplegia | Cerebrovascular Accident (CVA)United States
-
University of OklahomaRecruitingStroke | Weakness of Extremities as Sequela of StrokeUnited States
-
The Cleveland ClinicCompletedMultiple Sclerosis | Gait Disorders, NeurologicUnited States
-
Buckinghamshire Healthcare NHS TrustUnknown
-
Icahn School of Medicine at Mount SinaiNew York State Department of HealthCompletedSpinal Cord Injuries | InpatientUnited States
-
Parker Hannifin CorporationCompletedSpinal Cord InjuryUnited States
-
IRCCS San Raffaele RomaActive, not recruitingStroke | Brain Injuries, Traumatic | Brain Tumor BenignItaly