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Study of Hand Therapy 3 to 24 Months After Stroke

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand Mentor
Sponsored by
Kinetic Muscles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke rehabilitation, stroke therapy, hand therapy, stroke, cerebrovascular stroke, cerebral stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona State University, College of Nursing & Healthcare Innovation
  • Emory University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Hand Mentor

Outcomes

Primary Outcome Measures

Wolf Motor Function Test

Secondary Outcome Measures

Compliance with recommended use
Fugl-Meyer Test
Stoke Impact Scale

Full Information

First Posted
February 13, 2007
Last Updated
July 18, 2012
Sponsor
Kinetic Muscles
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00435617
Brief Title
Study of Hand Therapy 3 to 24 Months After Stroke
Official Title
Clinical Assessment of a Massed Practice Therapy Device
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kinetic Muscles
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
stroke rehabilitation, stroke therapy, hand therapy, stroke, cerebrovascular stroke, cerebral stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Hand Mentor
Intervention Type
Device
Intervention Name(s)
Hand Mentor
Other Intervention Name(s)
Hand Mentor Home
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Time Frame
Initial, 6 wks, 12 wks, 16 wks, 52 wks
Secondary Outcome Measure Information:
Title
Compliance with recommended use
Time Frame
6 wks, 12 wks
Title
Fugl-Meyer Test
Time Frame
Initial, 6 wks, 12 wks, 16 wks, 52 wks
Title
Stoke Impact Scale
Time Frame
Initial, 6 wks, 12 wks, 16 wks, 52 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Koeneman, Ph.D.
Organizational Affiliation
Kinetic Muscles, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven L Wolf, Ph.D., PT
Organizational Affiliation
Emory University Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard Herman, MD
Organizational Affiliation
Banner Good Samaritan Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Arizona State University, College of Nursing & Healthcare Innovation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17012642
Citation
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.
Results Reference
background
Links:
URL
http://www.kineticmuscles.com
Description
Company web site

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Study of Hand Therapy 3 to 24 Months After Stroke

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