Clinical trial NCT00435617: Study of Hand Therapy 3 to 24 Months After Stroke
Official title: Clinical Assessment of a Massed Practice Therapy Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: stroke rehabilitation
stroke therapy
hand therapy
stroke
cerebrovascular stroke
cerebral stroke
Lead sponsor: Kinetic Muscles
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2007-02-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Secondary outcomes:
measure: Compliance with recommended use
timeFrame: 6 wks, 12 wks
measure: Fugl-Meyer Test
timeFrame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
measure: Stoke Impact Scale
timeFrame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University, College of Nursing & Healthcare Innovation
state: Arizona
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Kinetic Muscles, Inc.
name: James B Koeneman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Medical School
name: Steven L Wolf, Ph.D., PT
role: STUDY_DIRECTOR
affiliation: Banner Good Samaritan Medical Center
name: Richard Herman, MD
role: STUDY_DIRECTOR
References:
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.