Evaluation of an Upright Powered Wheelchair for People With SCI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Bronx Veterans Medical Research Foundation, Inc
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Activities Daily Living Course - RPE
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
EunKyoung Hong
Postdoctoral Researcher
Bronx Veterans Medical Research Foundation, Inc
Eligibility Criteria
Inclusion Criteria
- •Power wheelchair user as a primary means of mobility;
- •18-89 years old;
- •≥1 year after SCI;
- •Height of 160 to 190 cm;
- •Weight of \<100 kg; and
- •Able to sign informed consent.
Exclusion Criteria
- •Able to ambulate with or without an assistive device or physical assistance greater than 4 consecutive steps;
- •Any pressure ulcer at any body location that is deemed to be contraindicated for a power wheelchair or standing frame by the study physician;
- •Concurrent medical disease that would be exclusionary for standing (as per the clinical judgment of the study physician);
- •Severe spasticity (Ashworth 4) or uncontrolled clonus;
- •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;
- •Significant contractures that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician
- •Psychiatric or cognitive status that may interfere with the ability to follow instruction to use the device; and
- •Pregnant or lactating women.
Outcomes
Primary Outcomes
Activities Daily Living Course - RPE
Time Frame: Training Period - 36 Sessions up to 12 weeks
Participants will be requested to perform a rating of perceived exertion (RPE) during the Activities Daily Living Course (ADLC).
Wheelchair mobility skills - RPE
Time Frame: Training Period - 36 Sessions up to 12 weeks
Participants will be requested to perform a rating of perceived exertion (RPE).
Wheelchair mobility skills - FIM
Time Frame: Training Period - 36 Sessions up to 12 weeks
Participants will be requested to perform a rating Functional Independence Measurement (FIM) for each UPnRIDE activity.
Activities Daily Living Course - FIM
Time Frame: Training Period - 36 Sessions up to 12 weeks
Participants will be requested to perform a rating Functional Independence Measurement (FIM) during the Activities Daily Living Course (ADLC).
Secondary Outcomes
- Lipid Profile - Cholesterols(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- SCI-QOL(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Pulmonary function tests - Spirometry(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Serum total testosterone levels(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Postural orthostatic hypotension blood pressure tolerance test (OH BP)(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Pulmonary function tests - Breathing Pattern(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Bowel function surveys - 10Q Bowel Function Survey (BFS)(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Pulmonary function tests - Static Lung Volumes(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Inflammatory biomarkers(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Body Composition(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Bowel function surveys - Bristol Stool Scale(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Homeostatic Model of Insulin Resistance (HOMA-IR)(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Serum estradiol levels(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))
- Lower extremity blood flow(Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks))