StrokeNCT02100306
The Role of Auditory Feedback in Guiding Upper Extremity Movements
A study testing Auditory Feedback 100% and Auditory Feedback 50% alternate in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Auditory Feedback 100% and Auditory Feedback 50% alternate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Sep 2015
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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%).
- Conditions
- Stroke
- Being tested
- Auditory Feedback 100%, Auditory Feedback 50% alternate
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory Feedback 100%Behavioural
Patients will receive constant auditory feedback across training trials.
Auditory Feedback 50% alternateBehavioural
Patients will receive alternating auditory feedback (1 trial auditory feedback; 1 trial no auditory feedback) across trials
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients will receive:
Auditory Feedback 100% Auditory Feedback 50% alternate Receives: Behavioral: Auditory Feedback 100%; Behavioral: Auditory Feedback 50% alternate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in movement error from baseline
Measured: 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 outcomes (2)
Change in range of motion
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce Chen, PhD, Principal investigator, Canadian Partnership for Stroke Recovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100306
- Sponsor's protocol ID
- JCH-1234-SF
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Auditory Feedback in Guiding Upper Extremity Movements
- ClinicalTrials.gov ID
- NCT02100306
- Acronym / sponsor ID
- JCH-1234-SF
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 31 Mar 2014 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: Auditory Feedback 100%, Behavioral: Auditory Feedback 50% alternatePatients will receive: Auditory Feedback 100% Auditory Feedback 50% alternate |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Auditory Feedback 100%Patients will receive constant auditory feedback across training trials. | Behavioural | Patients |
| Auditory Feedback 50% alternatePatients will receive alternating auditory feedback (1 trial auditory feedback; 1 trial no auditory feedback) across trials | Behavioural | Patients |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Related InfoLink provided by the sponsor.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Joyce Chen, PhD principal investigator
Canadian Partnership for Stroke Recovery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Feedback 100% and Auditory Feedback 50% alternate in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Mar 2014. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tea Lulic, MSc (416 480-6100 ext. 85405, tlulic@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2014.