Min Wee Phua

Recruiting participants for clinical trials targeting specific populations, like patients with chronic motor complete spinal cord injuries (SCIs), is challenging. The RESTORES trial evaluated spinal cord stimulation (SCS) combined with robotic neurorehabilitation for motor recovery in this population. This feasibility study enrolled three participants to assess SCS implant safety, synergistic effects of SCS and robotic rehabilitation, and clinical outcomes. Key recruitment barriers included the small patient pool, stringent eligibility criteria, patient skepticism, and logistical and emotional challenges. Strategies to address these challenges encompassed multidisciplinary collaborations with clinical centers, SCI associations, and patient support groups, including pre-surgical counselling and transparent communication. A dedicated clinical research coordinator ensured ethical compliance, logistical support, and participant engagement. Travel reimbursements, family involvement, and peer advocacy fostered accessibility and trust. Of the 115 patients screened, only 3 met the strict eligibility criteria, due to high screening failure rates and participant apprehension. Peer testimonials and family support helped enhance motivation and adherence. Ethical safeguards, like a data safety monitoring board, ensured participant safety and transparency. The RESTORES trial underscores the complexity of recruiting for pioneering interventions while highlighting the importance of tailored, patient-centric strategies. Insights gained will inform future trials and contribute to advancing SCI rehabilitation, offering hope for enhanced neurological recovery and quality of life for individuals with chronic motor complete SCI.

Spinal cord injury (SCI) is damage to any part of the spinal cord resulting in paralysis, bowel and/or bladder incontinence, and loss of sensation and other bodily functions. Current treatments for chronic SCI are focused on managing symptoms and preventing further damage to the spinal cord with limited neuro-restorative interventions. Recent research and independent clinical trials of spinal cord stimulation (SCS) or intensive neuro-rehabilitation including neuro-robotics in participants with SCI have suggested potential malleability of the neuronal networks for neurological recovery. We hypothesize that epidural electrical stimulation (EES) delivered via SCS in conjunction with mental imagery practice and robotic neuro-rehabilitation can synergistically improve volitional motor function below the level of injury in participants with chronic clinically motor-complete SCI. In our pilot clinical RESTORES trial (RESToration Of Rehabilitative function with Epidural spinal Stimulation), we investigate the feasibility of this combined multi-modal approach in restoring volitional motor control and achieving independent overground locomotion in participants with chronic motor complete thoracic SCI. Secondary aims are to assess the safety of this combination therapy including the off-label SCS usage as well as improving functional outcome measures. To our knowledge, this is the first clinical trial that investigates the combined impact of this multi-modal EES and rehabilitation strategy in participants with chronic motor complete SCI. Two participants with chronic motor-complete thoracic SCI were recruited for this pilot trial. Both participants have successfully regained volitional motor control below their level of SCI injury and achieved independent overground walking within a month of post-operative stimulation and rehabilitation. There were no adverse events noted in our trial and there was an improvement in post-operative truncal stability score. Results from this pilot study demonstrates the feasibility of combining EES, mental imagery practice and robotic rehabilitation in improving volitional motor control below level of SCI injury and restoring independent overground walking for participants with chronic motor-complete SCI. Our team believes that this provides very exciting promise in a field currently devoid of disease-modifying therapies.

SPM is a statistical method of analysis of time-varying human movement gait signal, depending on the random field theory (RFT). MovementRx is our inhouse-developed decision-support system that depends on SPM1D Python implementation of the SPM (spm1d.org). We present the potential application of MovementRx in the prediction of increased joint forces with the possibility to predispose to osteoarthritis in a sample of post-surgical Transtibial Amputation (TTA) patients who were ambulant in the community. We captured the three-dimensional movement profile of 12 males with TTA and studied them using MovementRx, employing the SPM1D Python library to quantify the deviation(s) they have from our corresponding reference data, using “Hotelling 2” and “T test 2” statistics for the 3D movement vectors of the 3 main lower limb joints (hip, knee, and ankle) and their nine respective components (3 joints × 3 dimensions), respectively. MovementRx results visually demonstrated a clear distinction in the biomechanical recordings between TTA patients and a reference set of normal people (ABILITY data project), and variability within the TTA patients’ group enabled identification of those with an increased risk of developing osteoarthritis in the future. We conclude that MovementRx is a potential tool to detect increased specific joint forces with the ability to identify TTA survivors who may be at risk for osteoarthritis.