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Completed

NCT Number: NCT02445768

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive multisensory rehabilitation

Other

Primary outcomes

  1. Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2023
First posted
May 15, 2015
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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