A New Rehabilitation Treatment Following Stroke
A Randomised Controlled Study of Early vs. Late, and Unisensory vs. Multisensory Rehabilitation for Stroke Patients With Perceptual and Cognitive Impairments.
2 other identifiers
interventional
17
1 country
1
Brief Summary
Stroke is the number one cause of disability in the United Nations with about 1 million new cases each year. Following stroke, patients with perceptual and cognitive impairments have the worst prognostic outcomes. There is evidence to suggest that perceptual and cognitive symptoms can be alleviated by multisensory integration, which has the effect of enhancing motor, perceptual and cognitive processes. This research project will investigate for the first time the functional benefits that stem from multisensory stimulation of attention in stroke patients with perceptual and cognitive impairments. The research project will involve multisensory learning paradigms with stimulus and environmental parameters that optimally enhance perceptual learning and cognitive function. Multisensory learning paradigms will be tailored for patients with stroke to determine the perceptual and cognitive symptoms that can be alleviated, and fMRI will be used to evaluate the underlying neural substrates of the effects. The project will show whether multisensory stimulation provides an effective means of attentional rehabilitation after stroke and whether the effects generalize to everyday life, with long-term outcomes that improve functional independence in patients with stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2016
CompletedNovember 17, 2017
November 1, 2017
1.3 years
June 23, 2015
November 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The efficacy of multisensory vs. unisensory rehabilitation program for stroke participants with perceptual impairments at the acute vs. chronic stage of the disorder.
Changes in performance on neuropsychological tests throughout the rehabilitation program, and 1 month and 6 months post rehabilitation.
4 years
Secondary Outcomes (1)
Changes in brain networks related to the recovery of perceptual and cognitive functions.
4 years
Study Arms (4)
Multisensory Acute
EXPERIMENTALMultisensory intervention delivered within 2 months post-stroke.
Multisensory Chronic
EXPERIMENTALMultisensory intervention delivered 6 months post-stroke.
Unisensory Acute
ACTIVE COMPARATORUnisensory intervention delivered within 2 months post-stroke.
Unisensory Chronic
ACTIVE COMPARATORUnisensory intervention delivered 6 months post-stroke.
Interventions
A randomised control design, comparing individuals who will receive visual unisensory stimulation alone (i.e., the control rehabilitation) and those who receive multisensory stimulation (i.e., the experimental rehabilitation), will be used to assess the effects of multisensory rehabilitation on learning, performance accuracy and speed in participants with neglect/extinction.
Eligibility Criteria
You may qualify if:
- Participant is willing and able to give informed consent for participation in the study.
- Participants who have a history of stroke (within the last 2 days - 2 months) and demonstrate a clinical deficit in unilateral neglect and/ or extinction on our standardised measure from the Oxford Cognitive Screen (OCS) and/or extinction task from BCoS (Birmingham Cognitive Screen).
- Participants have sufficient comprehension and concentration to undergo cognitive screening lasting about 1 hour (BCoS sub-tests, and other neglect and extinction related tests).
- Participants are medically stable.
- Participants with no history of other neurological and psychiatric disorders with exception of stroke.
You may not qualify if:
- Participants unwilling or unable to give consent.
- Participants without cognitive deficits and unilateral neglect or extinction.
- Participants who cannot concentrate sufficiently to undergo the screening and/or who are not medically stable.
- Participants with a history of other neurological and psychiatric disorders (with exception of stroke).
- Counter-indicators for fMRI (only relevant to the brain scanning portion of the study). Participants with counter-indicators for fMRI will still be invited to take part in the rehabilitation program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oxford
Oxford, OX1 3UD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2015
First Posted
June 26, 2015
Study Start
June 4, 2015
Primary Completion
September 30, 2016
Study Completion
September 30, 2016
Last Updated
November 17, 2017
Record last verified: 2017-11