NCT02445768

Brief Summary

The purpose now is to:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

May 4, 2015

Last Update Submit

March 8, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cognitive multisensory rehabilitation

EXPERIMENTAL

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

Other: Cognitive multisensory rehabilitation

Interventions

Cognitive multisensory rehabilitationOTHER
Cognitive multisensory rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medically stable;
  • years of age;
  • able to hear the instructions given during the study
  • at least 6 months post-stroke;
  • medically stable;
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

    PMID: 33219267BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne Van de Winckel, PhD, MS, PT

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 15, 2015

Study Start

December 1, 2015

Primary Completion

February 28, 2020

Study Completion

February 28, 2023

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

US(1)