A crossover pilot study evaluating the functional outcomes of two different types of robotic movement training in chronic stroke survivors using the arm exoskeleton BONES

Abstract

Background: To date, the limited degrees of freedom (DOF) of most robotic training devices hinders them from providing functional training following stroke. We developed a 6-DOF exoskeleton ("BONES") that allows movement of the upper limb to assist in rehabilitation. The objectives of this pilot study were to evaluate the impact of training with BONES on function of the affected upper limb, and to assess whether multijoint functional robotic training would translate into greater gains in arm function than single joint robotic training also conducted with BONES.

Methods: Twenty subjects with mild to moderate chronic stroke participated in this crossover study. Each subject experienced multijoint functional training and single joint training three sessions per week, for four weeks, with the order of presentation randomized. The primary outcome measure was the change in Box and Block Test (BBT). The secondary outcome measures were the changes in Fugl-Meyer Arm Motor Scale (FMA), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and quantitative measures of strength and speed of reaching. These measures were assessed at baseline, after each training period, and at a 3-month follow-up evaluation session.

Results: Training with the robotic exoskeleton resulted in significant improvements in the BBT, FMA, WMFT, MAL, shoulder and elbow strength, and reaching speed (p < 0.05); these improvements were sustained at the 3 month follow-up. When comparing the effect of type of training on the gains obtained, no significant difference was noted between multijoint functional and single joint robotic training programs. However, for the BBT, WMFT and MAL, inequality of carryover effects were noted; subsequent analysis on the change in score between the baseline and first period of training again revealed no difference in the gains obtained between the types of training.

Conclusions: Training with the 6 DOF arm exoskeleton improved motor function after chronic stroke, challenging the idea that robotic therapy is only useful for impairment reduction. The pilot results presented here also suggest that multijoint functional robotic training is not decisively superior to single joint robotic training. This challenges the idea that functionally-oriented games during training is a key element for improving behavioral outcomes.

Trial registration: NCT01050231.

Figure 1

Crossover study design. All participants took part in the single joint and multijoint functional robotic training programs, with the order randomized. Subjects in Sequence A received single joint robotic training first, followed by a 1-week break, and then received multijoint functional robotic training. Subjects in Sequence B participated in the multijoint functional robotic training first, followed by a 1-week break and then participated in the single joint robotic training. Each period of training lasted 4 weeks. Two clinical assessments were conducted at baseline (Assessment 1), one after the first robotic training period (Assessment 2), one after the second robotic training period (Assessment 3) and one at a 3-month follow-up assessment (Assessment 4).

Figure 2

BONES exoskeleton and examples of each robotic training program. a) Subject training on BONES (Written informed consent was obtained from the subject for the publication of his picture); b) examples of games played during multijoint functional robotic training, c) example of single joint robotic training (shoulder flexion/extension).

Figure 3

Summary of clinical and robotic outcome measures as a function of time across all subjects. a) The primary outcome measure of the study, the Box and Block Test. b) The principle component score of all clinical outcome measures over the duration of the study. c) The principle component scores for all maximum coordinated movement strength (CMS) measurements taken with the robot. d) The results for the robotic reaching task. Error bars represent standard error of the mean. The empty space at week 5 indicates the 1-week break. Assessments 1, 2, 3 and 4 correspond to assessments taken at baseline, after the first 4 weeks of training, after completion of 8 weeks of training, and at a 3-month follow-up, respectively.

Figure 4

Results of each training type for the clinical and robotic measurements. a) The primary outcome measure of the study, the Box and Block Test. b) The principle component score of all clinical outcome measures over the duration of the study. c) The principle component scores for all coordinated movement strength (CMS) measurements. d) The time of completion of the robotic reaching task. Error bars represent standard error of the mean.