Study of Hand Therapy 3 to 24 Months After Stroke
Clinical Assessment of a Massed Practice Therapy Device
1 other identifier
interventional
78
1 country
2
Brief Summary
The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2005
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 13, 2007
CompletedFirst Posted
Study publicly available on registry
February 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 20, 2012
July 1, 2012
4 years
February 13, 2007
July 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wolf Motor Function Test
Initial, 6 wks, 12 wks, 16 wks, 52 wks
Secondary Outcomes (3)
Compliance with recommended use
6 wks, 12 wks
Fugl-Meyer Test
Initial, 6 wks, 12 wks, 16 wks, 52 wks
Stoke Impact Scale
Initial, 6 wks, 12 wks, 16 wks, 52 wks
Study Arms (1)
A
EXPERIMENTALHand Mentor
Interventions
Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.
Eligibility Criteria
You may qualify if:
- to 24 months post stroke
- Able to extend wrist and fingers at least 10 degrees
- Functional hearing and vision
- Able to follow instructions
- Lives at home, not institution
- Stable medications for 3 months
You may not qualify if:
- Excessive cognitive impairments
- Taking/Receiving medicines/shots to make arm/hand less stiff
- Severe pain in the impaired arm
- Stroke was more than 24 months ago
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Arizona State University, College of Nursing & Healthcare Innovation
Phoenix, Arizona, 85004, United States
Emory University
Atlanta, Georgia, 30322, United States
Related Publications (1)
Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. doi: 10.2522/ptj.20050149.
PMID: 17012642BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James B Koeneman, Ph.D.
Kinetic Muscles, Inc.
- STUDY DIRECTOR
Steven L Wolf, Ph.D., PT
Emory University Medical School
- STUDY DIRECTOR
Richard Herman, MD
Banner Good Samaritan Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Science Officer
Study Record Dates
First Submitted
February 13, 2007
First Posted
February 15, 2007
Study Start
May 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2010
Last Updated
July 20, 2012
Record last verified: 2012-07