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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT04163796
Study groupRoleWhat they receive
UPnRIDE TrainingExperimentalDuring 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.

  1. 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

  2. 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

  3. 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

  4. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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.

  1. First posted15 Nov 2019
  2. Study start1 Aug 2018
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2023

Resources

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)
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

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.

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