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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870189
• Other study ID #: CMR
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: University of Minnesota
• Contact: Ann Van de Winckel, PhD,MSPT,PT
• Phone: 612-625-1191
• Email: avandewi[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Remote CMR
12 weeks of remote CMR is done 3x/week, 45 min/session.
• Remote Exercise
12 weeks of remote exercise is done 3x/week, 45 min/session.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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