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Randomized Controlled Trial
. 2013 Jan;8(1):46-53.
doi: 10.1111/j.1747-4949.2012.00971.x.

The home stroke rehabilitation and monitoring system trial: a randomized controlled trial

Susan M Linder  1 , Anson B Rosenfeldt, Aimee Reiss, Sharon Buchanan, Komal Sahu, Curtis R Bay, Steven L Wolf, Jay L Alberts
Affiliations
Randomized Controlled Trial

The home stroke rehabilitation and monitoring system trial: a randomized controlled trial

Susan M Linder et al. Int J Stroke. 2013 Jan.

Abstract

Rationale: Because many individuals poststroke lack access to the quality and intensity of rehabilitation to improve upper extremity motor function, a home-based robotic-assisted upper extremity rehabilitation device is being paired with an individualized home exercise program.

Aims/hypothesis: The primary aim of this project is to determine the effectiveness of robotic-assisted home therapy compared with a home exercise program on upper extremity motor recovery and health-related quality of life for stroke survivors in rural and underserved locations. The secondary aim is to explore whether initial degree of motor function of the upper limb may be a factor in predicting the extent to which patients with stroke may be responsive to a home therapy approach. We hypothesize that the home exercise program intervention, when enhanced with robotic-assisted therapy, will result in significantly better outcomes in motor function and quality of life.

Design: A total of 96 participants within six-months of a single, unilateral ischemic, or hemorrhagic stroke will be recruited in this prospective, single-blind, multisite randomized clinical trial.

Study outcomes: The primary outcome is the change in upper extremity function using the Action Research Arm Test. Secondary outcomes include changes in: upper extremity function (Wolf Motor Function Test), upper extremity impairment (upper extremity portion of the Fugl-Meyer Test), self-reported quality of life (Stroke Impact Scale), and affect (Centers for Epidemiologic Studies Depression Scale).

Discussion: Similar or greater improvements in upper extremity function using the combined robotic home exercise program intervention compared with home exercise program alone will be interpreted as evidence that supports the introduction of in-home technology to augment the recovery of function poststroke.

Trial registration: ClinicalTrials.gov NCT01144715.

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Conflict of interest statement

Conflict of Interest Statement: Dr. Wolf is Chairman of the Scientific Advisory Board for Kinetic Muscles Inc., and is a paid consultant for Kinetic Muscles Inc. Sharon Buchanan is a paid consultant for Kinetic Muscles Inc. No other authors have any financial relationship with Kinetic Muscles Inc.

Figures

Figure 1
Figure 1
Diagram depicting expected recruitment numbers and study flow during participants’ course of enrolment
Figure 2
Figure 2
Illustration of the Hand Mentor Pro robotic device: a) control box b) arm unit
Figure 3
Figure 3
Sample screen shots of two of the motor control programs: a) strongman b) balloon game
See this image and copyright information in PMC

References

    1. Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, et al. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010;41(10):2402–48. Epub 2010/09/04. - PubMed
    1. Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003;34(9):2181–6. Epub 2003/08/09. - PubMed
    1. Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005;352(16):1677–84. Epub 2005/04/22. - PMC - PubMed
    1. Johansson BB. Brain Plasticity and Stroke Rehabilitation: The Willis Lecture. Stroke. 2000;31(1):223–30. - PubMed
    1. Jenkins WM, Merzenich MM. Reorganization of neocortical representations after brain injury: a neurophysiological model of the bases of recovery from stroke. Progress in brain research. 1987;71:249–66. Epub 1987/01/01. - PubMed

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