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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02995200
Other study ID # IRB-FY2016-182
Secondary ID
Status Completed
Phase N/A
First received December 14, 2016
Last updated September 25, 2017
Start date February 2015
Est. completion date December 2016

Study information

Verified date September 2017
Source Cleveland State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:

i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in healthy individuals and individuals chronic post-stroke,

ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs,

iii.) quantify and compare amount of UE use in healthy controls to that of people chronic post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and

iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between healthy controls and subjects post-chronic stroke pre and post feedback (for the people after stroke).


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 100 Years
Eligibility Inclusion Criteria:

- Healthy Adults: 40-100 years old, able to follow 2-step commands, able to comply with experimental protocol, living in a home setting, full active range of motion (AROM) in both shoulders and elbows for their age group.

- Individuals Post-stroke: Able to follow 2-step commands, 40 - 100 years old, community dwelling with or without assistance, no upper extremity (UE) injury within the last 3 months, at least 30 degrees of flexion AROM (with or without assistance) and PROM in shoulder and elbow in or out of synergy, intact superficial light touch sensation in both UEs, and at least 6 months post ischemic or hemorrhagic stroke that is either cortical, subcortical or in the cerebellum. It does not need to be their first and only stroke.

Exclusion Criteria:

- Healthy Adults: Injury of either UE within the last 3 months and unable to follow commands related to the accelerometer use/protocol.

- Individuals Post-stroke: Unable to follow 2 step commands, inability to adhere to study requirements, any neurological diagnosis other than stroke (i.e. Parkinson's Disease, Multiple Sclerosis, etc.), and aphasia limiting their ability to complete the MoCA and Stroke Impact Scale (SIS) questions.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Accelerometer Based Feedback


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cleveland State University

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of Use (measured by accelerometer) 3 week period
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