Seated Balance Using the Indego™

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047992
• Other study ID #: SPU-17-029
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Traumatic or non-traumatic SCI =6 months duration of SCI;

2. Wheelchair-user for indoor and outdoor mobility;

3. Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);

4. Able to hold the crutches in hands with or without modifications; and

5. Able to provide informed consent.

Exclusion Criteria:

1. Diagnosis of neurological injury other than SCI;

2. Progressive condition that would be expected to result in changing neurological status;

3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;

4. Anthropocentric incompatibility to be fitted with the device;

5. Traumatic or high impact lower extremity fracture within the past 2 years;

6. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;

7. Knee BMD < 0.60 gm/cm2;

8. Total hip BMD T-scores < -3.5;

9. Untreatable severe spasticity judged to be contraindicated by the Site Physician;

10. Flexion contracture that is incompatible with the device;

11. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion > 00);

12. Fracture of the foot by x-ray and confirmed by CT;

13. Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);

14. Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;

15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;

16. History of seizure;

17. Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;

18. History of stroke, brain tumor, brain abscess, or multiple sclerosis;

19. 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);

20. History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;

21. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or

22. Pregnancy or women who plan to become pregnant during the study period.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Indego™ Exoskeleton
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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spinal Cord Independence Measure (SCIM)	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.
Primary	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	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.	Change from baseline after 8 weeks and after 12 weeks.
Secondary	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.	Change from baseline after 8 weeks and after 12 weeks.