Clinical Study of a Novel, Body-weight Supported, Balance-perturbation Module During the Rehabilitation of Gait and Balance Impairments Secondary to Stroke: A Multisite Randomized Control Trial

Each year, more than 795,000 people experience a stroke. Stroke, or cerebral vascular accident, is a devastating neurological event that can lead to physical and cognitive deficits, such as the inability to ambulate, impaired balance regulation, loss of coordination, and impaired communication. Due to the physical and cognitive deficits experienced following a stroke, many require admission to an inpatient rehabilitation facility with the goal of maximizing their independence before returning to the home setting. Gait and balance dysfunction are common secondary impairments to stroke, usually requiring specific rehabilitative interventions.

Following a stroke, motion analysis has observed patients navigating obstacles more conservatively and with abnormal gait patterns. One associated factor is the loss of muscle-strength secondary to stroke, which could increase the risk of falling. Within six-months of discharge, falls occur in up to 70% of patients post-stroke, highlighting the importance and urgency to improve patients' balance and gait during the rehabilitation phase.

As patients may better understand their capabilities/limitation than what the physical tests demonstrate, patient self-assessments can be important indicators of fall risk. In fact, it is estimated that over 90% of stroke survivors would report that the fear of falling negatively impacts their performance of daily living activities. Fear of falling has been shown to influence balance and gait control in older adults, supporting the theory that balance and gait should be taken into account during rehabilitative methods. These psychological factors are strong predictors of falling compared to physical factors or the presence of pathology. Patient self-assessments are important indicators of fall risk, as patients may understand their capabilities/limitation better than what physical tests can demonstrate.

The ability to walk, stand, and climb stairs are examples of mobility-related functional tasks that are critical for achieving functional independence. With those with stroke related balance and gait impairments, early and frequent balance and gait training are essential to maximizing functional ability and independence. However, it is often difficult for post-stroke patients with these impairments to safely undergo the necessary balance and gait training without putting both therapists and patients at risk for injury. It is also reasonable to suspect that any injurious falls that occur during rehabilitation would reinforce, or create, a psychological fear of falling that would impede the recovery of the patient.

Furthermore, injurious falls can prolong a patient's length of stay, increasing the economic and financial strain both to the individual and their family as the patient is out work. Any falls, but especially injurious falls, can also increase the financial burden of an institution. In some cases, patients need to be carefully examined and imaged to confirm the presence or absence of injury. If the necessary imaging equipment isn't available, a patient may need to be taken to an outside location or even emergently transferred. Improving a patient's gait and balance earlier in their stay may also prevent other injurious falls outside of therapy as well. It could also improve a patient's fall risk, meaning that resources, such as safety sitters, can be minimized, further improving the financial burden of the institution. These benefits can be achieved, in part, by focusing on and improving a patient's balance and gait status. Incorporating robotic technologies to neurological rehabilitation can play a critical role in delivering safe and effective gait and balance therapy sooner in a patient's stay.