Robotic Exoskeleton for Multiple Sclerosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Steroids, Benzodiazepines, Antipsychotics, Neuroleptics

Disqualifiers: Head injury, Stroke, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with Multiple Sclerosis (MS) improve walking, learning, and memory. It compares a robotic exoskeleton, a wearable device that assists with movement, to traditional physical therapy. Individuals who have difficulty walking due to MS and some cognitive challenges but can still walk with assistance may be suitable candidates. The goal is to determine if the exoskeleton provides better results than regular therapy. As an unphased trial, this study allows participants to explore innovative treatments that could enhance their quality of life.

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 prior data suggests that this robotic exoskeleton is safe for use in individuals with multiple sclerosis?

Research has shown that the robotic exoskeleton device, such as the EksoNR, is safe for people with multiple sclerosis (MS) to use. The FDA has approved the EksoNR for assisting those with MS and brain injuries, confirming its safety through testing. Another study found that using a similar exoskeleton for balance training was both feasible and safe. Additionally, a small study with MS patients demonstrated improvements in movement and cognitive abilities, with no major safety issues reported. Overall, the evidence suggests that using a robotic exoskeleton for therapy is generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a robotic exoskeleton for multiple sclerosis (MS) because it offers a new way to enhance gait rehabilitation. Unlike conventional gait therapy, which relies on traditional exercises under the supervision of a physical therapist, the robotic exoskeleton provides a high-tech, wearable solution. This device can offer consistent, precise movements, potentially improving mobility and strength more effectively. The technology aims to provide personalized and adaptive support, which could lead to better outcomes and greater independence for people with MS.

What evidence suggests that the robotic exoskeleton is effective for improving mobility in multiple sclerosis?

Research has shown that robotic exoskeletons can help people with multiple sclerosis (MS) move better and think more clearly. One study found that using a robotic exoskeleton improved walking, thinking, and brain function in people with MS. Another study confirmed that these devices are safe and practical for assisting with balance. Additionally, wearable exoskeletons have reduced disability and improved quality of life for people with neurological disorders. In this trial, participants will receive either Robotic Exoskeleton Therapy or Conventional Gait Therapy. These findings suggest that robotic exoskeleton therapy could be a promising way to help people with MS walk better and possibly improve their memory and learning. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 haven't had MS symptoms worsen in the last month.

Exclusion Criteria

Pregnant

High degree of difficulty in thinking and problem solving that prevents participation in the study

I have a history of significant neurological issues other than MS.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Exoskeleton Rehabilitation

Trial Overview 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.

How Is the Trial Designed?

Group I: Robotic Exoskeleton Therapy Experimental Treatment 1 Intervention

Gait rehabilitation provided using a wearable robotic exoskeleton

Group II: Conventional Gait Therapy Active Control 1 Intervention

Gait rehabilitation provided using traditional gait therapy under the supervision of a licensed PT

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Kessler Institute for Rehabilitation

Industry Sponsor

Trials

23

Recruited

1,100+

Published Research Related to This Trial

Exoskeleton-assisted walking was found to be feasible and safe for about one-third of the 13 participants with multiple sclerosis, with moderate learnability requiring 5 to 15 sessions to achieve minimal assistance in walking.

While the device showed good safety with manageable adverse events, participants experienced varying levels of satisfaction and some improvements in posture and spasticity, suggesting potential secondary benefits from routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study. Kozlowski, AJ., Fabian, M., Lad, D., et al.[2018]

In a pilot study involving 43 severely affected patients with multiple sclerosis, robotic-assisted gait training (RAGT) resulted in significantly greater improvements in walking ability compared to conventional walking training (CWT).

RAGT not only enhanced gait competencies but also improved overall global ability, mobility, and reduced perceived fatigue, indicating its potential as a beneficial intervention for non-autonomous ambulant patients with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does robot-assisted gait training improve ambulation in highly disabled multiple sclerosis people? A pilot randomized control trial. Pompa, A., Morone, G., Iosa, M., et al.[2018]

In a study of 20 patients with multiple sclerosis, using the powered exoskeleton (Ekso) for gait training resulted in significant improvements in walking speed, mobility, and mental well-being compared to traditional gait training.

The powered exoskeleton was well-accepted and demonstrated good usability, suggesting it could be a valuable tool for enhancing functional outcomes in patients with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can powered exoskeletons improve gait and balance in multiple sclerosis? A retrospective study. Russo, M., Maggio, MG., Naro, A., et al.[2021]

A study involving 44 patients with multiple sclerosis showed that using the ExoAtlet exoskeleton significantly improved walking function and overall neurological status, with a notable reduction in the Extended Disability Status Scale (EDSS) score by 0.23 points after the first rehabilitation course and 0.64 points after three months.

Cognitive functions also improved, as indicated by a 4.5% increase in the Symbol Digit Modalities Test (SDMT) score for the main group, and a remarkable 52% improvement in the second subgroup after their second rehabilitation course, highlighting the potential of robotic mechanotherapy in enhancing both physical and cognitive abilities in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robotic mechanotherapy in patients with multiple sclerosis with impaired walking function]. Gevorkyan, AA., Kotov, SV., Lizhdvoy, VY.[2020]

Integrating the Ekso Gait Training device into inpatient rehabilitation for patients with stroke or spinal cord injury is feasible, although it faced initial challenges that required administrative support and clinician persistence over several months.

Patients using the Ekso reported improved mobility and tolerated the sessions well, with no complications or adverse incidents, indicating a positive experience with the robotic exoskeleton.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Swank, C., Sikka, S., Driver, S., et al.[2021]

The pilot study involving 18 patients with multiple sclerosis demonstrated that the ExoAtlet exoskeleton is well-tolerated during 30-40 minute sessions and showed a significant positive trend in improving neurological function as measured by the EDSS scale (p<0.01).

After using the ExoAtlet, patients experienced increased walking speed and stability, along with improved support function, indicating that robotic-assisted walking may help restore movement abilities in MS patients with locomotor disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of the exoskeleton ExoAtlet to restore walking in patients with multiple sclerosis]. Kotov, SV., Lijdvoy, VY., Sekirin, AB., et al.[2019]

The Rex Rehab exoskeleton device was found to be feasible and safe for balance rehabilitation in a study involving 11 adults with multiple sclerosis, with 10 participants completing the protocol without safety issues.

Participants showed improvements in balance, joint mobility, spasticity, and quality of life, indicating potential health benefits from using the exoskeleton during rehabilitation exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III). Sakel, M., Saunders, K., Hodgson, P., et al.[2023]

A study involving 54 participants with multiple sclerosis showed high satisfaction levels for both patients and physiotherapists using the EKSO GT® exoskeleton for gait training, indicating its positive impact on rehabilitation.

Patients reported that the effectiveness, safety, and impact on gait were the most valued features of the EKSO GT®, although improvements in comfort and weight of the device were suggested for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Robotic Gait Training in Persons with Multiple Sclerosis: A Satisfaction Study. Fernández-Vázquez, D., Cano-de-la-Cuerda, R., Gor-García-Fogeda, MD., et al.[2021]

Citations

1. eksobionics.com eksobionics.com/robotic-exoskeletons-for-multiple-sclerosis-patients-2/

Robotic Exoskeletons for Multiple Sclerosis Patients Exoskeletons present a more advanced and better rehabilitation solution for patients with MS to recover their mobility skills.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211034821002030

A pilot randomized controlled trial of robotic exoskeleton ... This study tested REAER effects on mobility, cognition, and fMRI outcomes in 10 PwMS. REAER improved mobility, cognition, and brain connectivity based on ...

3. eksobionics.com eksobionics.com/eksonr/

EksoNR EksoNR is a robotic exoskeleton specifically designed to be used in a rehabilitation setting to progress neurorehab patients so they can walk out of the device ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8309837/

Wearable Robotic Gait Training in Persons with Multiple ... Wearable exoskeletons have showed improvements in levels of disability and quality of life in people with neurological disorders.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9774743/

FEASIBILITY AND SAFETY OF A POWERED ... These results suggest that it is feasible and safe to use the Rex Rehab exoskeleton device to assist with balance rehabilitation for people living with multiple ...

6. provider.healthybluenc.com provider.healthybluenc.com/medpolicies/healthybluenc/active/mp_pw_c176719.html

OR-PR.00006 Powered Robotic Lower Body Exoskeleton ... This document addresses the use of powered, robotic lower body exoskeleton devices that may be utilized in the rehabilitation of or for daily use by ...