NCT02100306

Brief 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. 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%).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

March 14, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

March 14, 2014

Last Update Submit

March 26, 2014

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in movement error from baseline

    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

    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

    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)

Study Arms (1)

Patients

EXPERIMENTAL

Patients will receive: Auditory Feedback 100% Auditory Feedback 50% alternate

Behavioral: Auditory Feedback 100%Behavioral: Auditory Feedback 50% alternate

Interventions

Auditory Feedback 100%BEHAVIORAL

Patients will receive constant auditory feedback across training trials.

Patients
Auditory Feedback 50% alternateBEHAVIORAL

Patients will receive alternating auditory feedback (1 trial auditory feedback; 1 trial no auditory feedback) across trials

Patients

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joyce Chen, PhD

    Canadian Partnership for Stroke Recovery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tea Lulic, MSc

CONTACT

416 480-6100tlulic@sri.utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 31, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

CA(1)