Back to resultsRemotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Spinal Cord Diseases
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Remote CMR
Remote Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Remote CMR
Remote exercises
Arm Description
adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention.
adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention.
Outcomes
Primary Outcome Measures
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
the Neuromuscular Recovery Scale (NRS)
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.
the Neuromuscular Recovery Scale (NRS)
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.
The SCI-FI/AT
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
The SCI-FI/AT
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05870189
Brief Title
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Official Title
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote CMR
Arm Type
Experimental
Arm Description
adults with SCI without restriction for race, sex or socio-economic status randomized to CMR intervention.
Arm Title
Remote exercises
Arm Type
Placebo Comparator
Arm Description
adults with SCI without restriction for race, sex or socio-economic status randomized to remote exercise intervention.
Intervention Type
Behavioral
Intervention Name(s)
Remote CMR
Intervention Description
12 weeks of remote CMR is done 3x/week, 45 min/session.
Intervention Type
Behavioral
Intervention Name(s)
Remote Exercise
Intervention Description
12 weeks of remote exercise is done 3x/week, 45 min/session.
Primary Outcome Measure Information:
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
Description
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
Time Frame
baseline
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
Description
a clinical test originally designed to describe the extent and severity of a patient's SCI/D
Time Frame
12 weeks
Title
the Neuromuscular Recovery Scale (NRS)
Description
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.
Time Frame
baseline
Title
the Neuromuscular Recovery Scale (NRS)
Description
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.
Time Frame
12 weeks
Title
The SCI-FI/AT
Description
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
Time Frame
baseline
Title
The SCI-FI/AT
Description
(32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Van de Winckel, PhD,MSPT,PT
Phone
612-625-1191
Email
avandewi@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Van de Winckel, PhD, MSPT, PT
Phone
612-406-2500
Email
avandewi@umn.edu
12. IPD Sharing Statement
Learn more about this trial
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
We'll reach out to this number within 24 hrs