Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)

The purpose now is to:

1. identify brain connections related to proprioception to have a better understanding of differences between people with stroke and healthy persons
2. evaluate how these brain connections will change in people with stroke when they are engaged in 6-week cognitive multisensory rehabilitation.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Cognitive multisensory rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for healthy subjects are:

• medically stable;
• 18 - 99 years of age;
• able to hear the instructions given during the study

Inclusion criteria for stroke patients are:

• at least 6 months post-stroke;
• medically stable;
• 18 - 99 years of age;
• subcortical or cortical infarct confirmed with MRI;
• Mini-mental State Exam > 24/30 (Folstein et al., 1975);
• able to hear the instructions given during the study;
• able to comprehend the instructions given during the study;
• able to commit time to participate in a 6-12-weeks rehabilitation program

Exclusion Criteria:

• having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment;
• severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
• contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position;
• interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
• exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
• pregnant or nursing mother;
• adults lacking capacity to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive multisensory rehabilitation; The treatment group will receive the cognitive multisensory rehabilitation that uses motor imagery and sensory discrimination exercises	Other: Cognitive multisensory rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation	The robots will be used for research in healthy adults and stroke patients in the proposed studies below and are designed to mimick the exercises given during cognitive multisensory rehabilitation. The robots have been tested and cleared by the 3T safety committee at the CMRR, U of M. The first objective is a feasibility study to investigate the brain mechanisms of cognitive multisensory rehabilitation, through use of the robot in the 3T scanner at the U of M in healthy participants with stroke. Changes in brain function will be measured in individuals with stroke who will receive 8 weeks of therapy.	8 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Anne Van de Winckel, PhD, MS, PT, University of Minnesota

Publications and helpful links

General Publications

• Van de Winckel A, De Patre D, Rigoni M, Fiecas M, Hendrickson TJ, Larson M, Jagadeesan BD, Mueller BA, Elvendahl W, Streib C, Ikramuddin F, Lim KO. Exploratory study of how Cognitive Multisensory Rehabilitation restores parietal operculum connectivity and improves upper limb movements in chronic stroke. Sci Rep. 2020 Nov 20;10(1):20278. doi: 10.1038/s41598-020-77272-y.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PMR-2015-23168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No