Your session is about to expire
← Back to Search
CMR for Spinal Cord Injury
N/A
Waitlist Available
Led By Ann Van de Winckel, PhD, MSPT, PT
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will compare the effects of two different treatments on sensorimotor function in adults with SCI/D.
Who is the study for?
This trial is for adults with spinal cord injuries that happened at least 3 months ago and are medically stable. It's not suitable for those who have other major medical issues, are pregnant, depend on a ventilator, can't undergo MRI scans due to certain hardware in their body, have uncontrolled seizures or cognitive impairments that would prevent them from following instructions.Check my eligibility
What is being tested?
The study is testing Cognitive Multisensory Rehabilitation (CMR) against adaptive fitness programs to see which one helps better with sensory and motor recovery in people with spinal cord injury. Participants will be randomly assigned to either the CMR program or an adaptive fitness routine for 8 weeks.See study design
What are the potential side effects?
Since this trial involves rehabilitation techniques rather than drugs, side effects may include muscle soreness or fatigue related to physical therapy exercises. There might also be discomfort associated with participation in new activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brain Motor Control Assessment (BMCA)
Change in ISNCSCI Neurologic exam (ASIA test)
Change in International Spinal Cord Injury Pain Basic Set Version 2.0 (SCI Pain Test) which includes the numerical pain rating scale
+2 moreSecondary outcome measures
Change in Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Change in Moorong Self-Efficacy Scale (MSES)
Change in Patient Health Questionnaire (PHQ-9)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Multisensory Rehabilitation (CMR) GroupExperimental Treatment1 Intervention
After the baseline testing, participants in the CMR group will receive 8 weeks of one-on-one, in-person therapy, 3 times a week, for 45 min. The CMR sessions will be recorded on video.
The participants will undergo clinical assessments and MRI scans at 3 time points: at baseline; a post-intervention after the first 8 weeks of CMR and a clinical assessment (no MRI) at 3 months.
Group II: Adaptive Fitness GroupActive Control1 Intervention
After the baseline testing, participants in the adapted fitness group will start with a fitness assessment and then complete a fitness program under supervision for 8 weeks, 3x/week, for 45 min. Staff at the Courage Kenny Rehabilitation Institute will monitor training adherence through a log sheet.
The participants will undergo clinical assessments and MRI scans at 3 times points: at baseline; a post-intervention after the first 8 weeks of adaptive fitness and a clinical assessment (no MRI) at 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Multisensory Rehabilitation (CMR)
2022
N/A
~30
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,469 Total Patients Enrolled
Ann Van de Winckel, PhD, MSPT, PTPrincipal InvestigatorUniversity of Minnesota Medical School Department of Rehabilitation Medicine
2 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other serious health problems.You cannot have an MRI due to specific medical reasons, unless you have stabilizing hardware which is usually safe for MRI.You have seizures that are not being controlled.You have difficulty understanding or communicating due to a brain injury or other cognitive impairment.You rely on a ventilator to help you breathe.You have had a spinal cord injury for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive Fitness Group
- Group 2: Cognitive Multisensory Rehabilitation (CMR) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the chief aims of this investigation?
"This study aims to measure the efficacy of an intervention by observing changes in International Spinal cord injury Pain Basic Set Version 2.0 (SCI Pain Test) after 3 Months. Secondary objectives include gauging alterations in Patient Health Questionnaire (PHQ-9), Tampa Scale for Fear of Re-Injury, and Patient-Specific Functional Scale scores across thesame period."
Answered by AI
Is recruitment currently underway for this study?
"This medical study, initially posted on June 1st 2022, is actively searching for participants according to the information provided by clinicaltrials.gov. It was last edited on 21/6/2022."
Answered by AI
What is the total count of participants enrolled in this experiment?
"Correct. Clinicaltrials.gov records demonstrate that this medical study, which was posted on June 1st 2022, is actively seeking participants. Currently, the trial requires 16 people to be recruited from a single site."
Answered by AI
Is this research recruiting geriatric patients?
"This trial only permits patients aged 18-75 to participate. However, there are many other clinical trials available for those under the legal age of consent and those over retirement age; 138 and 732 respectively."
Answered by AI
Who are the accepted participants for this research project?
"To qualify for this medical study, prospective participants must have a spinal cord injury and be aged between 18-75 years old. Currently, the clinical trial is enrolling approximately 16 individuals."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger