StrokeNCT02445768
Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
A study testing Cognitive multisensory rehabilitation in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive multisensory rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medically stable;
- 18 - 99 years of age;
- able to hear the instructions given during the study
- at least 6 months post-stroke;
- medically stable;
- 18 - 99 years of age;
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Stroke
- Being tested
- Cognitive multisensory rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive multisensory rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Cognitive multisensory rehabilitation | Experimental | The treatment group will receive the cognitive multisensory rehabilitation that uses motor imagery and sensory discrimination exercises Receives: Other: Cognitive multisensory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2015
- Primary completion28 Feb 2020
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Van de Winckel, PhD, MS, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445768
- Sponsor's protocol ID
- PMR-2015-23168
- Status last verified
- Mar 2023
- First submitted
- 4 May 2015
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33219267
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
- ClinicalTrials.gov ID
- NCT02445768
- Acronym / sponsor ID
- PMR-2015-23168
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive multisensory rehabilitation | Experimental | Other: Cognitive multisensory rehabilitationThe treatment group will receive the cognitive multisensory rehabilitation that uses motor imagery and sensory discrimination exercises |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- medically stable;
- 18 - 99 years of age;
- able to hear the instructions given during the study
- at least 6 months post-stroke;
- medically stable;
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive multisensory rehabilitation | Other | Cognitive multisensory rehabilitation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 33219267Van 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Van de Winckel, PhD, MS, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive multisensory rehabilitation in people with Stroke, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.