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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Cognitive multisensory rehabilitation

• Registration Number: NCT02445768
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Study Start: 2015-12
• Primary Completion: 2020-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation	8 weeks	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.

Trial Locations

Locations (1)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States