Clinical trial NCT04163796: UPnRIDE Power Standing Wheelchair for SCI
Official title: Evaluation of an Upright Powered Wheelchair for People With SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Bronx Veterans Medical Research Foundation, Inc
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with higher level of spinal cord injury have limitations to using exoskeletal-assisted walking devices due to restrictions of trunk stability, functional use of the upper extremities and hand grip. With increasing sedentary time in wheelchairs, people with SCI have a high risk for developing secondary complications. A powered wheelchair has recently been developed for use in persons with spinal cord injury that provides a solution for placing the user in an upright, standing position while maintaining the overground mobility features of the powered wheelchair; providing the ability to engage in society in either a standing or seated position. The purpose of this study is to verify user performances of the upright powered wheelchair and to identify obstacles that are difficult, or prevent use. Additionally, the option to have upright posture throughout the day may have the potential to improve some of the secondary medical conditions associated with the extreme sedentary lifestyle.

This study will determine change from baseline after 12 weeks of use for safety, tolerance, medical, physical and quality of life outcomes. The intervention will consist of 3.5 hours per session, 3 times per week for 12 weeks. During each session, participants will be asked to stand at least 5 minutes during every 15 minutes. To our knowledge, there is no existing empirical data on intermittent standing during the day in persons with higher levels of SCI who cannot otherwise stand and whether this approach will improve health related outcomes.


Eligibility criteria: Inclusion Criteria:

1. Power wheelchair user as a primary means of mobility;
2. 18-89 years old;
3. ≥1 year after SCI;
4. Height of 160 to 190 cm;
5. Weight of \<100 kg; and
6. Able to sign informed consent.

Exclusion Criteria:

1. Able to ambulate with or without an assistive device or physical assistance greater than 4 consecutive steps;
2. Any pressure ulcer at any body location that is deemed to be contraindicated for a power wheelchair or standing frame by the study physician;
3. Concurrent medical disease that would be exclusionary for standing (as per the clinical judgment of the study physician);
4. Severe spasticity (Ashworth 4) or uncontrolled clonus;
5. History of fragility fractures, long bone fractures in the past 1 years, heterotrophic ossification, or other bone conditions that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician;
6. Significant contractures that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician
7. Psychiatric or cognitive status that may interfere with the ability to follow instruction to use the device; and
8. Pregnant or lactating women.

Primary outcomes:
measure: Wheelchair mobility skills - RPE
timeFrame: Training Period - 36 Sessions up to 12 weeks
measure: Wheelchair mobility skills - FIM
timeFrame: Training Period - 36 Sessions up to 12 weeks
measure: Activities Daily Living Course - RPE
timeFrame: Training Period - 36 Sessions up to 12 weeks
measure: Activities Daily Living Course - FIM
timeFrame: Training Period - 36 Sessions up to 12 weeks
Secondary outcomes:
measure: Postural orthostatic hypotension blood pressure tolerance test (OH BP)
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Pulmonary function tests - Spirometry
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Pulmonary function tests - Static Lung Volumes
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Pulmonary function tests - Breathing Pattern
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Inflammatory biomarkers
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Body Composition
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Bowel function surveys - 10Q Bowel Function Survey (BFS)
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Bowel function surveys - Bristol Stool Scale
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: SCI-QOL
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Lipid Profile - Cholesterols
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Homeostatic Model of Insulin Resistance (HOMA-IR)
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Serum total testosterone levels
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Serum estradiol levels
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
measure: Lower extremity blood flow
timeFrame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Spinal Cord Damage Research Center
state: New York
Study officials:
affiliation: Bronx VMRF
name: EunKyoung Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References: