Upper limb sensorimotor recovery in Asian stroke survivors: a study protocol for the development and implementation of a Technology-Assisted dIgitaL biOmaRker (TAILOR) platform.

Background: Stroke is a leading cause of lifelong disability worldwide, partially driven by a reduced ability to use the upper limb in daily life causing increased dependence on caregivers. However, post-stroke functional impairments have only been investigated using limited clinical scores, during short-term longitudinal studies in relatively small patient cohorts. With the addition of technology-based assessments, we propose to complement clinical assessments with more sensitive and objective measures that could more holistically inform on upper limb impairment recovery after stroke, its impact on upper limb use in daily life, and on overall quality of life. This paper describes a pragmatic, longitudinal, observational study protocol aiming to gather a uniquely rich multimodal database to comprehensively describe the time course of upper limb recovery in a representative cohort of 400 Asian adults after stroke. Particularly, we will characterize the longitudinal relationship between upper limb recovery, common post-stroke impairments, functional independence and quality of life. Methods: Participants with stroke will be tested at up to eight time points, from within a month to 3 years post-stroke, to capture the influence of transitioning from hospital to community settings. We will perform a battery of established clinical assessments to describe the factors most likely to influence upper limb recovery. Further, we will gather digital health biomarkers from robotic or wearable sensing technology-assisted assessments to sensitively characterize motor and somatosensory impairments and upper limb use in daily life. We will also use both quantitative and qualitative measures to understand health-related quality of life. Lastly, we will describe neurophysiological motor status using transcranial magnetic stimulation. Statistics: Descriptive analyses will be first performed to understand post-stroke upper limb impairments and recovery at various time points. The relationships between digital biomarkers and various domains will be explored to inform key aspects of upper limb recovery and its dynamics using correlation matrices. Multiple statistical models will be constructed to characterize the time course of upper limb recovery post-stroke. Subgroups of stroke survivors exhibiting distinct recovery profiles will be identified. Conclusion: This is the first study complementing clinical assessments with technology-assisted digital biomarkers to investigate upper limb sensorimotor recovery in Asian stroke survivors. Overall, this study will yield a multimodal data set that longitudinally characterizes post-stroke upper limb recovery in functional impairments, daily-life upper limb use, and health-related quality of life in a large cohort of Asian stroke survivors. This data set generates valuable information on post-stroke upper limb recovery and potentially allows researchers to identify different recovery profiles of subgroups of Asian stroke survivors. This enables the comparisons between the characteristics and recovery profiles of stroke survivors in different regions. Thus, this study lays out the basis to identify early predictors for upper limb recovery, inform clinical decision-making in Asian stroke survivors and establish tailored therapy programs. Clinical trial registration: ClinicalTrials.gov, identifier: NCT05322837.

Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands.

Post stroke upper limb rehabilitation is a challenging problem with poor outcomes as 40% of survivors have functionally useless upper limbs. Robot-aided therapy (RAT) is a potential method to alleviate the effort of intensive, task-specific, repetitive upper limb exercises for both patients and therapists. The present study aims to investigate how a time matched combinatory training scheme that incorporates conventional and RAT, using H-Man, compares with conventional training toward reducing workforce demands. In a randomized control trial (NCT02188628, www.clinicaltrials.gov), 44 subacute to chronic stroke survivors with first-ever clinical stroke and predominant arm motor function deficits were recruited and randomized into two groups of 22 subjects: Robotic Therapy (RT) and Conventional Therapy (CT). Both groups received 18 sessions of 90 min; three sessions per week over 6 weeks. In each session, participants of the CT group received 90 min of 1:1 therapist-supervised conventional therapy while participants of the RT group underwent combinatory training which consisted of 60 min of minimally-supervised H-Man therapy followed by 30 min of conventional therapy. The clinical outcomes [Fugl-Meyer (FMA), Action Research Arm Test and, Grip Strength] and the quantitative measures (smoothness, time efficiency, and task error, derived from two robotic assessment tasks) were independently evaluated prior to therapy intervention (week 0), at mid-training (week 3), at the end of training (week 6), and post therapy (week 12 and 24). Significant differences within group were observed at the end of training for all clinical scales compared with baseline [mean and standard deviation of FMA score changes between baseline and week 6; RT: Δ4.41 (3.46) and CT: Δ3.0 (4.0); p < 0.01]. FMA gains were retained 18 weeks post-training [week 24; RT: Δ5.38 (4.67) and week 24 CT: Δ4.50 (5.35); p < 0.01]. The RT group clinical scores improved similarly when compared to CT group with no significant inter-group at all time points although the conventional therapy time was reduced to one third in RT group. There were no training-related adverse side effects. In conclusion, time matched combinatory training incorporating H-Man RAT produced similar outcomes compared to conventional therapy alone. Hence, this study supports a combinatory approach to improve motor function in post-stroke arm paresis. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02188628.

Proprioceptive assessment in clinical settings: Evaluation of joint position sense in upper limb post-stroke using a robotic manipulator.

Proprioception is a critical component for motor functions and directly affects motor learning after neurological injuries. Conventional methods for its assessment are generally ordinal in nature and hence lack sensitivity. Robotic devices designed to promote sensorimotor learning can potentially provide quantitative precise, accurate, and reliable assessments of sensory impairments. In this paper, we investigate the clinical applicability and validity of using a planar 2 degrees of freedom robot to quantitatively assess proprioceptive deficits in post-stroke participants. Nine stroke survivors and nine healthy subjects participated in the study. Participants' hand was passively moved to the target position guided by the H-Man robot (Criterion movement) and were asked to indicate during a second passive movement towards the same target (Matching movement) when they felt that they matched the target position. The assessment was carried out on a planar surface for movements in the forward and oblique directions in the contralateral and ipsilateral sides of the tested arm. The matching performance was evaluated in terms of error magnitude (absolute and signed) and its variability. Stroke patients showed higher variability in the estimation of the target position compared to the healthy participants. Further, an effect of target was found, with lower absolute errors in the contralateral side. Pairwise comparison between individual stroke participant and control participants showed significant proprioceptive deficits in two patients. The proposed assessment of passive joint position sense was inherently simple and all participants, regardless of motor impairment level, could complete it in less than 10 minutes. Therefore, the method can potentially be carried out to detect changes in proprioceptive deficits in clinical settings.

Quantitative assessment of motor functions post-stroke: Responsiveness of upper-extremity robotic measures and its task dependence.

Technology aided measures offer a sensitive, accurate and time-efflcient approach for the assessment of sensorimotor function after neurological impairment compared to standard clinical assessments. This preliminary study investigated the relationship between task definition and its effect on robotic measures using a planar, two degree of freedom, robotic-manipulator (H-Man). Four chronic stroke participants (49.5±11.95 years, 2 Female, FMA: 37.5±13.96) and eight healthy control participants (26.25± 4.70 years, 2 Female) participated in the study. Motor functions were evaluated using line tracing and circle tracing tasks with dominant and nondominant hand of healthy and affected vs. non affected hand of stroke participants. The results show significant dependence of quantitative measures on investigated tasks.

Self-Paced Reaching after Stroke: A Quantitative Assessment of Longitudinal and Directional Sensitivity Using the H-Man Planar Robot for Upper Limb Neurorehabilitation.

Technology aided measures offer a sensitive, accurate and time-efficient approach for the assessment of sensorimotor function after neurological insult compared to standard clinical assessments. This study investigated the sensitivity of robotic measures to capture differences in planar reaching movements as a function of neurological status (stroke, healthy), direction (front, ipsilateral, contralateral), movement segment (outbound, inbound), and time (baseline, post-training, 2-week follow-up) using a planar, two-degrees of freedom, robotic-manipulator (H-Man). Twelve chronic stroke (age: 55 ± 10.0 years, 5 female, 7 male, time since stroke: 11.2 ± 6.0 months) and nine aged-matched healthy participants (age: 53 ± 4.3 years, 5 female, 4 male) participated in this study. Both healthy and stroke participants performed planar reaching movements in contralateral, ipsilateral and front directions with the H-Man, and the robotic measures, spectral arc length (SAL), normalized time to peak velocities (TpeakN ), and root-mean square error (RMSE) were evaluated. Healthy participants went through a one-off session of assessment to investigate the baseline. Stroke participants completed a 2-week intensive robotic training plus standard arm therapy (8 × 90 min sessions). Motor function for stroke participants was evaluated prior to training (baseline, week-0), immediately following training (post-training, week-2), and 2-weeks after training (follow-up, week-4) using robotic assessment and the clinical measures Fugl-Meyer Assessment (FMA), Activity-Research-Arm Test (ARAT), and grip-strength. Robotic assessments were able to capture differences due to neurological status, movement direction, and movement segment. Movements performed by stroke participants were less-smooth, featured longer TpeakN , and larger RMSE values, compared to healthy controls. Significant movement direction differences were observed, with improved reaching performance for the front, compared to ipsilateral and contralateral movement directions. There were group differences depending on movement segment. Outbound reaching movements were smoother and featured longer TpeakN values than inbound movements for control participants, whereas SAL, TpeakN , and RMSE values were similar regardless of movement segment for stroke patients. Significant change in performance was observed between initial and post-assessments using H-Man in stroke participants, compared to conventional scales which showed no significant difference. Results of the study indicate the potential of H-Man as a sensitive tool for tracking changes in performance compared to ordinal scales (i.e., FM, ARAT).

Effects of a robot-assisted training of grasp and pronation/supination in chronic stroke: a pilot study.

BACKGROUND: Rehabilitation of hand function is challenging, and only few studies have investigated robot-assisted rehabilitation focusing on distal joints of the upper limb. This paper investigates the feasibility of using the HapticKnob, a table-top end-effector device, for robot-assisted rehabilitation of grasping and forearm pronation/supination, two important functions for activities of daily living involving the hand, and which are often impaired in chronic stroke patients. It evaluates the effectiveness of this device for improving hand function and the transfer of improvement to arm function. METHODS: A single group of fifteen chronic stroke patients with impaired arm and hand functions (Fugl-Meyer motor assessment scale (FM) 10-45/66) participated in a 6-week 3-hours/week rehabilitation program with the HapticKnob. Outcome measures consisted primarily of the FM and Motricity Index (MI) and their respective subsections related to distal and proximal arm function, and were assessed at the beginning, end of treatment and in a 6-weeks follow-up. RESULTS: Thirteen subjects successfully completed robot-assisted therapy, with significantly improved hand and arm motor functions, demonstrated by an average 3.00 points increase on the FM and 4.55 on the MI at the completion of the therapy (4.85 FM and 6.84 MI six weeks post-therapy). Improvements were observed both in distal and proximal components of the clinical scales at the completion of the study (2.00 FM wrist/hand, 2.55 FM shoulder/elbow, 2.23 MI hand and 4.23 MI shoulder/elbow). In addition, improvements in hand function were observed, as measured by the Motor Assessment Scale, grip force, and a decrease in arm muscle spasticity. These results were confirmed by motion data collected by the robot. CONCLUSIONS: The results of this study show the feasibility of this robot-assisted therapy with patients presenting a large range of impairment levels. A significant homogeneous improvement in both hand and arm function was observed, which was maintained 6 weeks after end of the therapy.