Machine-Based, Self-guided Home Therapy for Individuals With Severe Arm Impairment After Stroke: A Randomized Controlled Trial

Abstract

Background: Few therapeutic options exist for the millions of persons living with severe arm impairment after stroke to increase their dose of arm rehabilitation. This study compared self-guided, high-repetition home therapy with a mechanical device (the resonating arm exerciser [RAE]) to conventional therapy in patients with chronic stroke and explored RAE use for patients with subacute stroke.

Methods: A total of 16 participants with severe upper-extremity impairment (mean Fugl-Meyer [FM] score = 21.4 ± 8.8 out of 66) >6 months poststroke were randomized to 3 weeks of exercise with the RAE or conventional exercises. The primary outcome measure was FM score 1 month posttherapy. Secondary outcome measures included Motor Activity Log, Visual Analog Pain Scale, and Ashworth Spasticity Scale. After a 1-month break, individuals in the conventional group also received a 3-week course of RAE therapy.

Results: The change in FM score was significant in both the RAE and conventional groups after training (2.6 ± 1.4 and 3.4 ± 2.4, P = .008 and .016, respectively). These improvements were not significant at 1 month. Exercise with the RAE led to significantly greater improvements in distal FM score than conventional therapy at the 1-month follow-up (P = .02). In a separate cohort of patients with subacute stroke, the RAE was found feasible for exercise.

Discussion: In those with severe arm impairment after chronic stroke, home-based training with the RAE was feasible and significantly reduced impairment without increasing pain or spasticity. Gains with the RAE were comparable to those found with conventional training and also included distal arm improvement.

Trial registration: ClinicalTrials.gov NCT01769326.

Keywords: exercise therapy; rehabilitation; self care; stroke; upper extremity.

Conflict of interest statement

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Daniel Zondervan, Nizan Friedman, and David Reinkensmeyer have a financial interest in Flint Rehabilitation Devices, LLC, a company that develops rehabilitation devices. The terms of this arrangement have been reviewed and approved by the University of California, Irvine, in accordance with its conflict of interest policies. The remaining authors declare that they have no competing interest.

© The Author(s) 2014.

Figures

Figure 1

The Resonating Arm Exerciser (RAE). RAE quickly attaches onto the wheelchair push rim. The user exercises rhythmically with the device at about 1 Hz by extending the shoulder and flexing the elbow (left) and flexing the shoulder and extending the elbow (right) in order to activate the resonance of the device. The device rolls back and forth in place during the exercise.

Figure 2

A flow of individuals participating in the study.

Figure 3

Top: Change in Fugl-Meyer score for both groups throughout the experiment (n=8). The diamonds (RAE group) and squares (conventional) show the mean change in FM Score at the Post-Exercise and 1 Month follow-up evaluations. The open squares denote the crossover period for the conventional group, and mark the mean change in FM Score for that group immediately after exercise with RAE, and 1 month after exercise with RAE. Bottom: Change in Fugl-Meyer score between the two groups separated into Proximal (bottom left) and Distal (bottom right) components. There was a significantly greater increase in distal FM score for subjects who exercised with RAE compared to the conventional group (p = 0.02, shown with a ‘+’). * denotes significant changes compared to baseline at p

Figure 4

Results from IMI assessment for the RAE group (n = 8, left bars) and conventional group (n = 7, right bars). Solid lines denote the median values and the shaded boxes show the interquartile range. Participants in the RAE group found the exercise to be significantly less stressful than conventional exercises (denoted by the ‘*’, p