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Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting (UnSumRes2015)

C

Cleveland State University

Status

Completed

Conditions

Healthy Control
Feedback Intervention (Participants Post-stroke)

Treatments

Behavioral: Accelerometer Based Feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT02995200
IRB-FY2016-182

Details and patient eligibility

About

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).

Enrollment

19 patients

Sex

All

Ages

40 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

Group Post-Stroke
Experimental group
Description:
2 sessions of in-home accelerometer based feedback about paretic arm use
Treatment:
Behavioral: Accelerometer Based Feedback
Healthy Control Group
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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