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?

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{3 5 6 7 8}

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. ^{2 3 5 6 7}

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

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

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

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]

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 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]

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 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]

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]

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]

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]

Citations

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Robotic mechanotherapy in patients with multiple sclerosis with impaired walking function]. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Can powered exoskeletons improve gait and balance in multiple sclerosis? A retrospective study. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Robotic Gait Training in Persons with Multiple Sclerosis: A Satisfaction Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. [2021]

5. Sweden 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). [2023]

6. United States 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. [2018]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The efficacy of the exoskeleton ExoAtlet to restore walking in patients with multiple sclerosis]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Does robot-assisted gait training improve ambulation in highly disabled multiple sclerosis people? A pilot randomized control trial. [2018]