Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury

June 22, 2023 updated by: University of Minnesota
So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ann Van de Winckel, PhD,MSPT,PT
  • Phone Number: 612-625-1191
  • Email: avandewi@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Ann Van de Winckel, PHD, MSPT, PT
          • Phone Number: 612-406-2500
          • Email: avandewi@umn.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-75 years old, with an incomplete or complete SCI/D of ≥ 3months, medically stable.
  • be recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community.

Exclusion Criteria:

  • adults with MRI contra-indications (stabilizing hardware is typically MRI safe);
  • adults with uncontrolled seizure disorder;
  • adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning;
  • adults with with ventilator dependency;
  • adults with other major medical complications
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote CMR
adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention.
Behavioral: Remote CMR
12 weeks of remote CMR is done 3x/week, 45 min/session.
Placebo Comparator: Remote exercises
adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention.
Behavioral: Remote Exercise
12 weeks of remote exercise is done 3x/week, 45 min/session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
Time Frame: baseline
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
baseline
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
Time Frame: 12 weeks
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
12 weeks
the Neuromuscular Recovery Scale (NRS)
Time Frame: baseline
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
baseline
the Neuromuscular Recovery Scale (NRS)
Time Frame: 12 weeks
includes 11 items focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. The NRS provides a functional recovery measure that focuses on non-compensatory recovery.
12 weeks
The SCI-FI/AT
Time Frame: baseline
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
baseline
The SCI-FI/AT
Time Frame: 12 weeks
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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