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Study of Hand Therapy 3 to 24 Months After Stroke

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ClinicalTrials.gov Identifier: NCT00435617
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : July 20, 2012
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
James Koeneman, Kinetic Muscles

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: Hand Mentor Not Applicable

Detailed Description:
Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Massed Practice Therapy Device
Study Start Date : May 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: A
Hand Mentor
Device: Hand Mentor
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.
Other Name: Hand Mentor Home



Primary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks ]

Secondary Outcome Measures :
  1. Compliance with recommended use [ Time Frame: 6 wks, 12 wks ]
  2. Fugl-Meyer Test [ Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks ]
  3. Stoke Impact Scale [ Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435617


Locations
United States, Arizona
Arizona State University, College of Nursing & Healthcare Innovation
Phoenix, Arizona, United States, 85004
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Kinetic Muscles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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

Additional Information:
Publications:
Responsible Party: James Koeneman, Chief Science Officer, Kinetic Muscles
ClinicalTrials.gov Identifier: NCT00435617     History of Changes
Other Study ID Numbers: R44HD041805 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by James Koeneman, Kinetic Muscles:
stroke rehabilitation
stroke therapy
hand therapy
stroke
cerebrovascular stroke
cerebral stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases