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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Behavioral: Remote CMR
* Behavioral: Remote Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline | 
| 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 | 12 weeks | 
| 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. | baseline | 
| 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. | 12 weeks | 
| The SCI-FI/AT | (32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation. | baseline | 
| The SCI-FI/AT | (32 items) reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation. | 12 weeks |