Trial to Test Wearable ‘Exoskeleton’ as Training Aid for Gait Problems
A clinical trial will evaluate how well a wearable “exoskeleton” device aids rehabilitation training to improve walking mechanics and neuromuscular function in people with Parkinson’s disease.
“Findings linked with the proposed study will likely give substantial solutions to the management of gait and postural disorders (posture, balance, and gait) in [Parkinson’s] where valid interventions (pharmacological, neurosurgery, traditional physiotherapy) are lacking,” the researchers wrote.
The pilot trial (NCT04778852), dubbed Ekso_PD, is recruiting 50 adults, ages 20 to 90, with mild-to-moderate disease and on stable Parkinson’s treatment to participate at two sites in Italy.
The study protocol, “Quantitative assessment of training effects using EksoGT® exoskeleton in Parkinson’s disease patients: A randomized single blind clinical trial,” was published in the journal Contemporary Clinical Trials Communications.Â
Gait alterations are a disabling Parkinson’s motor symptom that can ultimately lead to a greater risk of falls and hinder a person’s ability to walk independently. Restoring this ability is a main goal of Parkinson’s rehabilitation, which can be targeted with various forms of kinematic, or movement, therapy.
EksoGT is a wearable, battery-operated, gait training device developed by EksoBionics. Worn over a person’s clothes and fitted to their body, the device has specialized sensors and motors designed to enable individuals with weakness or paralysis in their lower limbs to stand and walk.
The Ekso_PD trial will evaluate the rehabilitative effects of a training program called over-ground wearable exoskeleton training (OWET), which involves the use of EksoGT in a real-world walking environment. Parkinson’s patients with gait problems and postural instability will be randomized to either OWET (25 patients) or a conventional kinematic comparator training program (25 patients).
Participants will receive three weekly sessions, each lasting about 45 minutes, of OWET or the comparator therapy over a four-week period. Each session will be administered by trained physical therapists.
Ekso_PD’s primary goal is to assess changes from the study’s start (baseline measures) in gait parameters, including joint movement, gait speed, step size, rhythm, balance, and muscle force after the intervention, and again four weeks later to determine how well changes are maintained. During the gait analysis, participants’ gait will be monitored with an eight-camera system, force plates to measure muscle force, and an electromyography system to monitor muscles’ electrical activity.
Evaluation of individual muscle force among trial participants might enable researchers to identify “patient-specific variables” that allow the therapy protocol to be adapted to each person, the team noted.
A secondary goal is to evaluate neurophysiological changes before and after treatment to investigate how the brain is responding to movement. These tests will involve electroencephalography (EEG) — which measures the brain’s electrical activity — during gait analysis.
In a smaller group of five participants, electromyography, EEG, and MRI imaging will be collected simultaneously while the participants flex their ankles, or imagine doing so, in the MRI scanner. Here, researchers aim to better understand the relationship between brain and muscle activity in response to the therapy.
“The coupling of movement evaluation, which assesses neuromuscular and biomechanical features, with neurological data, will better define the impact of the therapy on the relationship between [Parkinson’s] motor alterations and brain activity. This will provide an active treatment that is personalized and shared to large populations,” the researchers wrote.
Other secondary goals include changes in various clinical scales, including the Unified Parkinson’s Disease Rating Scale (UPDRS), the Parkinson’s Disease Questionnaire–39 (PDQ-39), and several questionnaires assessing balance, gait, and fall risk.
“This project addresses the potential for OWET to restore normal gait in [Parkinson’s] patients both at the level of improving the overall body motion and the lower joint stiffness, thereby improving function, quality of life, and reducing risk of injurious falls,” the researchers wrote.
Ekso_PD is expected to finish in June 2023.
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