Robotic Exoskeleton for Multiple Sclerosis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kessler Foundation
Must not be taking: Steroids, Benzodiazepines, Antipsychotics, Neuroleptics
Disqualifiers: Head injury, Stroke, Seizures, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research study is to evaluate the usefulness of a wearable robotic exoskeleton device (Ekso-GT), to improve learning and memory, and gait therapy in persons with walking disability due to Multiple Sclerosis. The study will evaluate the mobility, learning and memory, and walking abilities of individuals with multiple sclerosis who went through the traditional as compared to others who used the robotic exoskeleton as part of their therapy.
Will I have to stop taking my current medications?
The trial requires that you maintain a constant level of your spasticity medication, like baclofen, throughout the study. However, if you are currently taking steroids, benzodiazepines, antipsychotics, or neuroleptics, you may not be eligible to participate.
What data supports the effectiveness of the treatment Robotic Exoskeleton Rehabilitation for Multiple Sclerosis?
Research shows that using the Ekso exoskeleton can improve walking speed, mobility, and mental well-being in people with multiple sclerosis. Patients and therapists reported high satisfaction with the device, and it was found to be safe and well-tolerated during rehabilitation sessions.
12345Is the robotic exoskeleton safe for use in humans?
Research shows that the robotic exoskeleton, including models like Ekso GT and Ekso Bionics, is generally safe for humans. Studies report no complications or adverse incidents during use, and patients felt secure while using the device.
34567How does the robotic exoskeleton treatment differ from other treatments for multiple sclerosis?
The robotic exoskeleton treatment for multiple sclerosis is unique because it provides a new form of locomotor training that specifically targets gait and balance improvements. Unlike traditional therapies, this treatment uses a wearable device to assist with walking, which has shown significant improvements in walking speed, mobility, and mental well-being for patients.
12358Eligibility Criteria
This trial is for individuals aged 18-75 with multiple sclerosis who have moderate to severe walking difficulties but can still walk using an exoskeleton. Participants should have cognitive challenges, be stable in their MS treatment for at least a month, and fit the physical requirements for the exoskeleton (height between 60 and 76 inches, weight under 220 lbs).Inclusion Criteria
English as primary language
Some difficulty thinking and problem solving as determined by performance on a special test during screening visit
I am between 18 and 75 years old.
+12 more
Exclusion Criteria
Pregnant
I have a history of significant neurological issues other than MS.
High degree of difficulty in thinking and problem solving that prevents participation in the study
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive gait rehabilitation using either a wearable robotic exoskeleton or traditional gait therapy
12 weeks
Regular visits for therapy sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neuropsychological measures and brain scans
4 weeks
Participant Groups
The study compares traditional gait therapy to rehabilitation using a wearable robotic exoskeleton called Ekso-GT. It aims to assess improvements in mobility, learning, memory, and walking abilities in people with Multiple Sclerosis.
2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic Exoskeleton TherapyExperimental Treatment1 Intervention
Gait rehabilitation provided using a wearable robotic exoskeleton
Group II: Conventional Gait TherapyActive Control1 Intervention
Gait rehabilitation provided using traditional gait therapy under the supervision of a licensed PT
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kessler FoundationWest Orange, NJ
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Who Is Running the Clinical Trial?
Kessler FoundationLead Sponsor
Kessler Institute for RehabilitationIndustry Sponsor
References
[Robotic mechanotherapy in patients with multiple sclerosis with impaired walking function]. [2020]To study an effect of robotic mechanotherapy on the functional condition of patients with multiple sclerosis (MS) with impaired walking function using the ExoAtlet exoskeleton.
Can powered exoskeletons improve gait and balance in multiple sclerosis? A retrospective study. [2021]Multiple sclerosis (MS) is a progressive neurologic disorder that can profoundly influence mobility, independence and quality of life. Gait dysfunction in MS is common, resulting in an increased risk of losing walking ability. Robotic exoskeletons have been developed to offer a new form of locomotor training. The aim of our study was to investigate the effectiveness of the powered exoskeleton (Ekso) in improving gait and balance in patients affected by MS. Twenty patients with MS (mean ± SD: age = 43.7 ± 10.3 years; 66.7% male) were enrolled in this retrospective study. They were divided into two groups, matched for demographic data (age and sex) and medical characteristics (disease duration and Expanded Disability Status Scale), but differing for the type of rehabilitation training performed. Group 1 [experimental group (EG)] received gait training with the Ekso device, whereas group 2 (control group) performed traditional gait training. Although both trainings led to a significant improvement in the ability to walk and balance, only in the EG a significant improvement in walking speed (10 Meter Walk test; P = 0.002), in person's mobility (Timed Up and Go test; P = 0.002), and in the perception of mental well-being (MSQoL-M; P = 0.004), with a good usability and acceptance of the device, was found. Powered exoskeletons could be considered a valuable tool to improve functional outcomes and get the therapeutic goal in patients with MS.
Wearable Robotic Gait Training in Persons with Multiple Sclerosis: A Satisfaction Study. [2021]Wearable exoskeletons have showed improvements in levels of disability and quality of life in people with neurological disorders. However, it is important to understand users' perspectives. The aim of this study was to explore the patients' and physiotherapists' satisfaction from gait training with the EKSO GT® exoskeleton in people with multiple sclerosis (MS). A cross-sectional study with 54 participants was conducted. Clinical data and self-administered scales data were registered from all patients who performed sessions with EKSO GT®. To evaluate patients' satisfaction the Quebec User Evaluation with Assistive Technology and Client Satisfaction Questionnaire were used. A high level of satisfaction was reported for patients and for physiotherapists. A moderate correlation was found between the number of sessions and the patients' satisfaction score (rho = 0.532; p < 0.001), and an excellent correlation between the physiotherapists' time of experience in neurology rehabilitation and the satisfaction with the possibility of combining the device with other gait trainings approaches (rho = 0.723; p = 0.003). This study demonstrates a good degree of satisfaction for people with MS (31.3 ± 5.70 out of 40) and physiotherapists (38.50 ± 3.67 out of 45 points) with the EKSO GT®. Effectiveness, safety and impact on the patients' gait were the most highly rated characteristics of EKSO GT®. Features such as comfort or weight of the device should be improved from the patients' perspectives.
Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. [2021]Objective: Learning to walk is a major goal of inpatient rehabilitation and robotic exoskeletons may provide a new gait training approach. Our purpose was to determine the feasibility of integrating the Ekso Gait Training device into inpatient rehabilitation in a neurologic population.Design: Longitudinal cohort design and convenience sample including physical therapists trained to use the Ekso Bionics Ekso GT™ robotic exoskeleton or inpatients with stroke or SCI. Therapists completed a focus group and survey at baseline and 6 months after initial Ekso training. Patients completed a survey indicating their satisfaction with using the Ekso.Results: Twenty-five patients used the Ekso an average of 4.5 sessions during their 38.5-day rehabilitation stay. Survey and focus group feedback revealed that therapists encountered measurement difficulties with the Ekso and limited treatment time influencing effectiveness of usage. After 6 months, therapists reported an improvement in feasibility. Patients tolerated Ekso sessions well, without any complications or adverse incidents, and reported improved mobility post session.Conclusion: Integrating Ekso gait training into clinical practice was not seamless but appears feasible. Barriers were addressed within the rehabilitation team and received administrative support in a process lasting several months. Patients enjoyed walking in Ekso and felt secure within the device.Implications for rehabilitationIntegrating Ekso gait training into clinical practice during inpatient rehabilitation is feasible.Overcoming barriers to implementation required administrative support and clinician persistence over several months.Patients tolerated Ekso sessions well, without any complications or adverse incidents.
Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III). [2023]To evaluate the feasibility, usability, safety, and potential health benefits of using an exoskeleton device for rehabilitation of people living with multiple sclerosis.
Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study. [2018]To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS).
[The efficacy of the exoskeleton ExoAtlet to restore walking in patients with multiple sclerosis]. [2019]To investigate the efficacy and safety of the exoskeleton ExoAtlet in complex therapy of patients with multiple sclerosis (MS).
Does robot-assisted gait training improve ambulation in highly disabled multiple sclerosis people? A pilot randomized control trial. [2018]Robotic training is commonly used to assist walking training in patients affected by multiple sclerosis (MS) with non-conclusive results.