Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

Stroke Clinical Trial

Official title:

Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662960
• Other study ID #: HN 4404
• Secondary ID: NIH R01 HD068565
• Status: Completed
• Phase: N/A
• Start date: September 7, 2012
• Est. completion date: February 27, 2017

Study information

• Verified date: June 2020
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Description:

This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• 6 months or more post-stroke

• upper extremity Fugl-Meyer score between 10 and 50

• no longer participating in upper-extremity physical or occupational therapy

• sufficient comprehension ability to understand instructions

Exclusion Criteria:

• previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)

• dementia

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• Mirror therapy
A home-based therapy involving mirrored visual feedback
• Divider therapy
A home-based therapy involving removed visual feedback.

Locations

Country	Name	City	State
United States	Einstein Medical Center Elkins Park	Elkins Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Extremity Fugl-Meyer	This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.	Immediately after 1 month of treatment
Primary	Action Research Arm Test	The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.	1 month
Primary	Rivermead Assessment of Somatosensory Performance	This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.	1 month
Primary	Virtual-reality Assessment of Navigation	This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.	1 month
Secondary	Stroke Impact Scale	This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.	1 month
Secondary	Wolf Motor Function Test	The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.	1 months