- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02100306
The Role of Auditory Feedback in Guiding Upper Extremity Movements
Stroke is one of the leading causes of disability, with an estimated prevalence of 50,000 cases per year in Canada. Less than half of stroke patients regain use of their arm and hand. There is currently no intervention regime that is the gold standard, despite the variety of therapeutic techniques used to treat the upper extremity post-stroke. The use of external feedback to improve motor learning is a technique that has been less studied but shows promise. Therefore, the purpose of this proof of principle study it to test whether different auditory feedback frequencies can facilitate reaching ability in people with stroke. In addition brain scans will be collected that will enable us to determine how stroke severity may impact on one's ability to improve with this technique.
We hypothesize that patients who receive less feedback (50% alternate) will have enhanced learning relative to the patients who receive more feedback (100%).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Unilateral first time MCA ischemic stroke
- Stroke patients should have some movement of shoulder/elbow (no movement of hand - e.g. hand, fingers - is OK)
- > 2 months post
- between 30-85 years
Exclusion Criteria:
- prior stroke
- severe comprehension (or cognitive) deficit that compromises informed consent or understanding of instructions
- contraindications to MRI (e.g. claustrophobia, metal implants)
- neurodegenerative or psychiatric disease
- apraxia
- auditory deficits that would impair testing
- prior musculoskeletal injury to back or upper extremity (including shoulder subluxation from stroke)
- skin conditions that would preclude taping of goniometers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
Patients will receive: Auditory Feedback 100% Auditory Feedback 50% alternate |
Patients will receive constant auditory feedback across training trials.
Patients will receive alternating auditory feedback (1 trial auditory feedback; 1 trial no auditory feedback) across trials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in movement error from baseline
Time Frame: participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
|
participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in range of motion
Time Frame: participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
|
participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
|
|
Change in movement duration
Time Frame: participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
|
participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joyce Chen, PhD, Canadian Partnership for Stroke Recovery
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JCH-1234-SF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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