Effects of a 12-week, seated, virtual, home-based tele-exercise programme compared with a prerecorded video-based exercise programme in people with chronic neurological impairments: protocol for a randomised controlled trial.

INTRODUCTION: Exercise is vital to staying well and preventing secondary complications in people with chronic neurological impairments (CNI). Appropriate exercise is often inaccessible to this population. The purpose of the study is to investigate the effects of a seated, virtual exercise programme on heart rate, recovery, fatigue, pain, motivation, enjoyment and quality of life in people with CNI. METHODS AND ANALYSIS: Individuals with CNI will be screened for eligibility, and 60 participants will be randomised 1:1 into either a live or prerecorded group. There is no geographical limitation to where participants reside, since participation is virtual. The study will be coordinated by one site in White Plains, New York, USA. The live group will exercise with an instructor via Zoom while the prerecorded group will exercise at their chosen time using prerecorded videos, 3×/week for 12 weeks. PRIMARY OUTCOME MEASURES: change in heart rate during exercise/recovery. SECONDARY OUTCOME MEASURES: fatigue, motivation, level of pain and exertion, physical well-being, enjoyment of physical activity, motivation and quality of life. Outcomes will be assessed at baseline, midpoint, end of study and 1-month poststudy. Adverse events, medication changes and physical activity will be tracked throughout. Within-group and between-group comparisons will be performed by using analysis of covariance and regression. ETHICS AND DISSEMINATION: BRANY IRB approval: 22 September 2020, protocol #20-08-388-512. All participants will provide written informed consent. Results will be disseminated through presentations, publications and ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT04564495.

Walking improvement in chronic incomplete spinal cord injury with exoskeleton robotic training (WISE): a randomized controlled trial.

STUDY DESIGN: Clinical trial. OBJECTIVE: To demonstrate that a 12-week exoskeleton-based robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed, in community-dwelling participants with chronic incomplete spinal cord injury (iSCI). SETTING: Outpatient rehabilitation or research institute. METHODS: Multi-site (United States), randomized, controlled trial, comparing exoskeleton gait training (12 weeks, 36 sessions) with standard gait training or no gait training (2:2:1 randomization) in chronic iSCI (>1 year post injury, AIS-C, and D), with residual stepping ability. The primary outcome measure was change in robot-independent gait speed (10-meter walk test, 10MWT) post 12-week intervention. Secondary outcomes included: Timed-Up-and-Go (TUG), 6-min walk test (6MWT), Walking Index for Spinal Cord Injury (WISCI-II) (assistance and devices), and treating therapist NASA-Task Load Index. RESULTS: Twenty-five participants completed the assessments and training as assigned (9 Ekso, 10 Active Control, 6 Passive Control). Mean change in gait speed at the primary endpoint was not statistically significant. The proportion of participants with improvement in clinical ambulation category from home to community speed post-intervention was greatest in the Ekso group (>1/2 Ekso, 1/3 Active Control, 0 Passive Control, p < 0.05). Improvements in secondary outcome measures were not significant. CONCLUSIONS: Twelve weeks of exoskeleton robotic training in chronic SCI participants with independent stepping ability at baseline can improve clinical ambulatory status. Improvements in raw gait speed were not statistically significant at the group level, which may guide future trials for participant inclusion criteria. While generally safe and tolerable, larger gains in ambulation might be associated with higher risk for non-serious adverse events.

Abnormal synergistic gait mitigation in acute stroke using an innovative ankle-knee-hip interlimb humanoid robot: a preliminary randomized controlled trial.

Abnormal spasticity and associated synergistic patterns are the most common neuromuscular impairments affecting ankle-knee-hip interlimb coordinated gait kinematics and kinetics in patients with hemiparetic stroke. Although patients with hemiparetic stroke undergo various treatments to improve gait and movement, it remains unknown how spasticity and associated synergistic patterns change after robot-assisted and conventional treatment. We developed an innovative ankle-knee-hip interlimb coordinated humanoid robot (ICT) to mitigate abnormal spasticity and synergistic patterns. The objective of the preliminary clinical trial was to compare the effects of ICT combined with conventional physical therapy (ICT-C) and conventional physical therapy and gait training (CPT-G) on abnormal spasticity and synergistic gait patterns in 20 patients with acute hemiparesis. We performed secondary analyses aimed at elucidating the biomechanical effects of Walkbot ICT on kinematic (spatiotemporal parameters and angles) and kinetic (active force, resistive force, and stiffness) gait parameters before and after ICT in the ICT-C group. The intervention for this group comprised 60-min conventional physical therapy plus 30-min robot-assisted training, 7 days/week, for 2 weeks. Significant biomechanical effects in knee joint kinematics; hip, knee, and ankle active forces; hip, knee, and ankle resistive forces; and hip, knee, and ankle stiffness were associated with ICT-C. Our novel findings provide promising evidence for conventional therapy supplemented by robot-assisted therapy for abnormal spasticity, synergistic, and altered biomechanical gait impairments in patients in the acute post-stroke recovery phase.Trial Registration: Clinical Trials.gov identifier NCT03554642 (14/01/2020).

Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia.

BACKGROUND: While Walkbot-assisted locomotor training (WLT) provided ample evidence on balance and gait improvements, the therapeutic effects on cardiopulmonary and psychological elements as well as fall confidence are unknown in stroke survivors. OBJECTIVE: The present study aimed to compare the effects of Walkbot locomotor training (WLT) with conventional locomotor training (CLT) on balance and gait, cardiopulmonary and psychological functions and fall confidence in acute hemiparetic stroke. METHODS: Fourteen patients with acute hemiparetic stroke were randomized into either the WLT (60 min physical therapy + 30 min Walkbot-assisted gait training) or CLT (60 min physical therapy + 30 min gait training) groups, 7 days/week over 2 weeks. Clinical outcomes included the Berg Balance Scale (BBS), Functional Ambulation Category (FAC), heart rate (HR), Borg Rating of Perceived Exertion (BRPE), Beck Depression Inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale. The analysis of covariance (ANCOVA) was conducted at P < 0.05. RESULTS: ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P < 0.05), but not on BBS (P = 0.061). CONCLUSIONS: Our results provide novel, promising clinical evidence that WLT improved balance and gait function as well as cardiopulmonary and psychological functions, and fall confidence in acute stroke survivors who were unable to ambulate independently.