Quantification of UE Use and Effects of Feedback in the Home Setting

Stroke Clinical Trial

— OPTASpr2016  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995213
• Other study ID #: IRB-FY2016-84
• Status: Completed
• Phase: N/A
• First received: December 14, 2016
• Last updated: September 25, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

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

Clinical Trial Summary

The investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in 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 individuals chronic post-stroke,

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

iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 100 Years

Eligibility

Inclusion Criteria:

• Subjects post-stroke

• chronic post ischemic or hemorrhagic cortical or subcortical stroke

• 25 - 100 years old

• upper extremity impairment

• Subjects will need to be able to flex their paretic shoulder and their elbow > 40° without assist

• able to follow 2-step commands

• community dwelling with or without assistance

• intact superficial light touch sensation in both upper extremities

• must also have some movement in both arms

Exclusion Criteria:

• can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, Parkinson disease or multiple sclerosis

• no upper extremity injury within the last 3 months

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Accelerometer based feedback about paretic arm use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accelerometer based paretic arm amount of use		3 week period