Spinal Cord InjuriesNCT04163796
UPnRIDE Power Standing Wheelchair for SCI
A study testing UPnRIDE power wheelchair in people with Spinal Cord Injuries, run by Bronx Veterans Medical Research Foundation, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- UPnRIDE power wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spinal Cord Damage Research Center
The Bronx, New York, 10468
About this study
Official title: Evaluation of an Upright Powered Wheelchair for People With SCI
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- UPnRIDE power wheelchair
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPnRIDE power wheelchairDevice
The intervention will consist of approximately 3.5 hours per session, 3 times per week over 12 weeks. During each 3.5-hour session, subjects will be asked to stand at least 5 minutes during every 15 minutes or more as tolerated. One time each session, participants will be asked to perform the Activities of Daily Living course.
| Study group | Role | What they receive |
|---|---|---|
| UPnRIDE Training | Experimental | During each session, heart rate (HR), blood pressure (BP), total session time, time in standing posture, count of sit-to-stand positioning, total distance of overground movement, and rating of perceived exertion (Borg scale) for mobility skills will be monitored. At all study visits during the training period, participants will be asked to answer general health questions about the occurrence of any pressure ulcers or infections. Receives: Device: UPnRIDE power wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair mobility skills - RPE
Participants will be requested to perform a rating of perceived exertion (RPE).
Measured: Training Period - 36 Sessions up to 12 weeks
Wheelchair mobility skills - FIM
Participants will be requested to perform a rating Functional Independence Measurement (FIM) for each UPnRIDE activity.
Measured: Training Period - 36 Sessions up to 12 weeks
Activities Daily Living Course - RPE
Participants will be requested to perform a rating of perceived exertion (RPE) during the Activities Daily Living Course (ADLC).
Measured: Training Period - 36 Sessions up to 12 weeks
Activities Daily Living Course - FIM
Participants will be requested to perform a rating Functional Independence Measurement (FIM) during the Activities Daily Living Course (ADLC).
Measured: Training Period - 36 Sessions up to 12 weeks
Secondary outcomes (14)
Postural orthostatic hypotension blood pressure tolerance test (OH BP)
Participants will be in the supine position on a bed or elevated gym mat and beat-to-beat HR will be recorded for 60 seconds, followed by passive re-positioning to the seated position on a bed or elevated gym mat with the hip and knee at a 90° angle and the lower leg hanging off the side. Passive repositioning will be accomplished by one staff member lifting the participant's torso by the shoulders, while supporting the head and neck, and a second staff member shifting the subject perpendicular to the bed and allowing the participant's legs to hang off the side. Participants will be instructed not to assist in the passive movement during this transition, and will be supported by staff.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Pulmonary function tests - Spirometry
While seated in the chair and after a mouth piece and nose clip are applied, the subject will be asked to breathe normally for 3 to 6 breaths. They will then be instructed to forcibly inhale until their lungs are filled. After a brief pause, they will then be instructed to forcibly exhale the air in their lungs and hold the maneuver for approximately 6 seconds. After a brief rest, the maneuver will be repeated a minimum of three times to ensure reliability.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Pulmonary function tests - Static Lung Volumes
The volume of air in the lungs will be assessed using the nitrogen washout technique. The nitrogen washout technique, which takes about five minutes to perform, will begin while a subject is seated in his/her wheelchair and after a mouth piece and nose-clips have been applied. The subject will then be asked to breathe room air into and out of the mouthpiece for 3-6 breaths. The air exhaled, which normally contains mostly nitrogen, will be collected and analyzed by the pulmonary function cart. Once a participant has completed the 3-6 breaths, s/he will be asked to take a slow deep breath in and to exhale until the lungs are empty, after which the participant returns to a normal breathing pattern. Following an additional 3-6 regular breaths, the pulmonary function cart will begin delivering 100% oxygen through the mouthpiece. The subject will continue to inhale 100% oxygen while taking normal breaths until oxygen is the only gas measurable in his/her exhaled air.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Pulmonary function tests - Breathing Pattern
Resting breathing pattern will be measured by abdominal and thoracic respiratory inductive plethysmography. The participant will be asked to wear two chest straps for a designated period of time. Signals from the participant's chest wall excursions are analyzed for indices of resting breathing pattern such as tidal volume and timing and derivatives of these measurements.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Inflammatory biomarkers
Due to its clinical utility and widespread use to measure risks for coronary heart disease, the primary outcome assessment of systemic inflammation will be levels of CRP, which will be measured in sera using a commercially available ELISA. Additional exploratory analyses may be performed using commercially available single- and multi-plex immunoassays to assay the following: HMGb1, IL-1β, IL-1Ra, IL-6, IL-8, IL-10, IL-15, MIF, MIP1-α/CCL3, TNF-α, leptin, and adipokine.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Body Composition
A dual energy x-ray absorptiometry (DXA) scan for regional and total body fat, lean and bone tissue masses will be performed two times: at baseline and post.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Bowel function surveys - 10Q Bowel Function Survey (BFS)
The 10Q Bowel Function Survey (BFS) will be administered three times: at baseline, midpoint, and post.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Bowel function surveys - Bristol Stool Scale
The Bristol Stool Scale (BSS) will be administered three times: at baseline, midpoint, and post. The BSS is a diagnostic medical tool designed to classify the form of human faces into seven categories (Type 1 to 7: Hard lumps to Soft/Liquid).
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
SCI-QOL
The Spinal Cord Injury Quality of Life measurement tool is the first validated SCI-specific QOL measurement tool for the field. The specific short form item banks to be use are: Bowel and Bladder Management Difficulties from the Physical Medical Domain, Ability to Participate and Independence from the Social Domain, and Positive Affect, and Resilience from Emotional Domain. These will be performed three times: at baseline, midpoint, and post.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Lipid Profile - Cholesterols
Total cholesterol (TC), low density lipoprotein cholesterol (LDL-c), triglyceride (TG) and high density lipoprotein cholesterol (HDL-c) values will be measure and samples will be collected at baseline, midpoint and post.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Homeostatic Model of Insulin Resistance (HOMA-IR)
The standard equation for the HOMA-IR will be used to calculate insulin resistance [HOMA-IR = FPG (mg/dl) x FPI(μU/mL) / 405].
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Serum total testosterone levels
Serum total testosterone will be determined by a radioimmunoassay (RIA; MP Biomedicals, Costa Mesa, CA) kit with an intra-assay CV of 10.0, 9.6, and 13% at 1.4, 4.6, and 8.0 nmol/L41,61,62. Measurements will be performed pre, midpoint and post.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Serum estradiol levels
Serum estradiol values will be determined by a commercial kit assay using RIA (MP Biomedicals, Costa Mesa, CA) with an intra-assay CV of 15.7, 5.5, and 3.5% at 25.4, 152, and 657 pg/mL63. Measurements will be performed pre, midpoint and post.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Lower extremity blood flow
Lower extremity blood flow will be measured by strain gauge and will be assessed at sessions 1 and 36.
Measured: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Aug 2018
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx Veterans Medical Research Foundation, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EunKyoung Hong, Bronx Veterans Medical Research Foundation, Inc
- Investigators
- EunKyoung Hong, PhD, Principal investigator, Bronx VMRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163796
- Sponsor's protocol ID
- SPU-17-036
- Status last verified
- Jan 2024
- First submitted
- 18 Jun 2018
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Upright Powered Wheelchair for People With SCI
- ClinicalTrials.gov ID
- NCT04163796
- Acronym / sponsor ID
- SPU-17-036
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bronx Veterans Medical Research Foundation, IncUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UPnRIDE Training | Experimental | Device: UPnRIDE power wheelchairDuring each session, heart rate (HR), blood pressure (BP), total session time, time in standing posture, count of sit-to-stand positioning, total distance of overground movement, and rating of perceived exertion (Borg scale) for mobility skills will be monitored. At all study visits during the training period, participants will be asked to answer general health questions about the occurrence of any pressure ulcers or infections. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPnRIDE power wheelchairThe intervention will consist of approximately 3.5 hours per session, 3 times per week over 12 weeks. During each 3.5-hour session, subjects will be asked to stand at least 5 minutes during every 15 minutes or more as tolerated. One time each session, participants will be asked to perform the Activities of Daily Living course. | Device | UPnRIDE Training |
Primary outcome
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 - 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).
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).
14 secondary outcomes
Postural orthostatic hypotension blood pressure tolerance test (OH BP)
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Pulmonary function tests - Spirometry
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Pulmonary function tests - Static Lung Volumes
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Pulmonary function tests - Breathing Pattern
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Inflammatory biomarkers
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Body Composition
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Bowel function surveys - 10Q Bowel Function Survey (BFS)
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Bowel function surveys - Bristol Stool Scale
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
SCI-QOL
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Lipid Profile - Cholesterols
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Homeostatic Model of Insulin Resistance (HOMA-IR)
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Serum total testosterone levels
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Serum estradiol levels
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Lower extremity blood flow
Time frame: Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EunKyoung Hong, PhD principal investigator
Bronx VMRF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPnRIDE power wheelchair in people with Spinal Cord Injuries, run by Bronx Veterans Medical Research Foundation, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheelchair mobility skills - RPE (time frame: Training Period - 36 Sessions up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.