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Device

Manual Standing Wheelchair for Spinal Cord Injury (MMSW-SCI Trial)

N/A
Recruiting
Led By B. Jenny Kiratli, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Veterans with spinal cord injury between C7 and T12 (AIS A-C)
Decisional competency to provide consent and cognitive ability to participate fully in study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two months
Awards & highlights

MMSW-SCI Trial Summary

This trial will test whether a mobile manual standing wheelchair can help improve the health of people with spinal cord injuries by reducing the amount of time they spend sitting.

Who is the study for?
This trial is for Veterans with spinal cord injuries who use a manual wheelchair, weigh less than 275 lbs, have decision-making capacity, and fit the device size. They must be at least 6 months post-injury and not in another mobility study. Exclusions include low bone density, unhealed fractures or pressure injuries, recent flap surgery, inability to operate the chair or stand mechanism.Check my eligibility
What is being tested?
The study compares two types of wheelchairs: a newly developed mobile manual standing wheelchair (MMSW) that allows users to move while standing against a standard manual standing wheelchair. Participants will randomly receive one type to use for two months at home and in their community.See study design
What are the potential side effects?
Potential side effects may include discomfort from new seating positions or using the sit-to-stand feature. There could also be an increased risk of pressure sores if not used correctly and possible exacerbation of existing conditions like spasticity when adjusting to the new chair.

MMSW-SCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran with a spinal cord injury between my neck and mid-back.
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I am mentally capable of understanding and agreeing to the study's requirements.
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I need support to stand up on my own.
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I am not participating in any other mobility studies.
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I use a manual wheelchair to get around.
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I weigh less than 275 lb.

MMSW-SCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two months
This trial's timeline: 3 weeks for screening, Varies for treatment, and two months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Standing Dose - Total time standing - Existing Standing Device
Standing Dose - Total time standing - Study Wheelchair
Utility - Measured using the Wheelchair Outcome Measure

MMSW-SCI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Manual Standing WheelchairExperimental Treatment1 Intervention
Mobile in BOTH seated and standing positions
Group II: Manual Standing WheelchairActive Control1 Intervention
Mobile in seated position; Not mobile in standing position

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,381 Total Patients Enrolled
B. Jenny Kiratli, PhDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA
Andrew H Hansen, PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
2 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Manual Standing Wheelchair (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04668326 — N/A
Spinal Cord Injury Research Study Groups: Manual Standing Wheelchair, Mobile Manual Standing Wheelchair
Spinal Cord Injury Clinical Trial 2023: Manual Standing Wheelchair Highlights & Side Effects. Trial Name: NCT04668326 — N/A
Manual Standing Wheelchair (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04668326 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04668326 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment for this experiment currently open?

"This medical trial, which was initially announced on February 1st 2023, is not actively seeking patients anymore. According to clinicaltrials.gov the most recent update to this study occurred on September 1st 2022; however there are still 352 other trials searching for participants at present."

Answered by AI

Who else is applying?

What state do they live in?
California
Ohio
What site did they apply to?
VA Palo Alto Health Care System, Palo Alto, CA
Minneapolis VA Health Care System, Minneapolis, MN
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have major spinal cord damage. I’m not a veteran but I do meet the requirements as I am T2-5 Asia A.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Mobile Manual Standing Wheelchair for SCI
2023. "Mobile Manual Standing Wheelchair for SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04668326.
All > Spinal Cord Injury
~27 spots leftby Jun 2025
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