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Study of Hand Therapy 3 to 24 Months After Stroke

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Koeneman, Kinetic Muscles
ClinicalTrials.gov Identifier:
NCT00435617
First received: February 13, 2007
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention
Cerebrovascular Accident
Device: Hand Mentor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Massed Practice Therapy Device

Further study details as provided by Kinetic Muscles:

Primary Outcome Measures:
  • Wolf Motor Function Test [ Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance with recommended use [ Time Frame: 6 wks, 12 wks ] [ Designated as safety issue: No ]
  • Fugl-Meyer Test [ Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks ] [ Designated as safety issue: No ]
  • Stoke Impact Scale [ Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: May 2005
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
  More Information

Additional Information:
Publications:
Responsible Party: James Koeneman, Chief Science Officer, Kinetic Muscles
ClinicalTrials.gov Identifier: NCT00435617     History of Changes
Other Study ID Numbers: R44 HD041805, R44HD041805
Study First Received: February 13, 2007
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014