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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive multisensory rehabilitation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive multisensory rehabilitation

Arm Description

The treatment group will receive the cognitive multisensory rehabilitation that uses motor imagery and sensory discrimination exercises

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2015
Last Updated
March 8, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02445768
Brief Title
Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
Official Title
Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2023 (Actual)

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive multisensory rehabilitation
Arm Type
Experimental
Arm Description
The treatment group will receive the cognitive multisensory rehabilitation that uses motor imagery and sensory discrimination exercises
Intervention Type
Other
Intervention Name(s)
Cognitive multisensory rehabilitation
Primary Outcome Measure Information:
Title
Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Van de Winckel, PhD, MS, PT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33219267
Citation
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.
Results Reference
background
Links:
URL
https://www.med.umn.edu/rehabmedicine/research/awareness-after-stroke
Description
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Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)

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