Robotic Glove for ALS

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Southeastern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robotic glove designed to help people with Amyotrophic Lateral Sclerosis (ALS) improve grip strength, fine motor skills, and overall quality of life. Participants will use the glove for 20 minutes a day, five days a week, over eight weeks to assess its impact on daily tasks. This trial suits individuals with ALS who have lost some hand strength or fine motor skills and have a caregiver to assist with the glove. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance daily living for those with ALS.

Do I need to stop my current medications for the trial?

The trial requires that you have been on a stable dose of your current medications for at least 30 days, so you do not need to stop taking them.

What prior data suggests that this robotic glove is safe for individuals with ALS?

Research has shown that a robotic glove can be safe and helpful for people with ALS. One study found that the glove improved grip strength and fine motor skills without causing serious side effects. Participants demonstrated better arm function and overall quality of life. Another study found that people with ALS generally feel comfortable using robotic gloves. While the trials did not report major negative effects, some users might experience mild discomfort or tiredness. This assistive technology aims to make daily tasks easier and improve well-being.12345

Why are researchers excited about this trial?

The Robotic Glove for ALS is unique because it offers a new way to assist patients with muscle movement. Traditional ALS treatments often focus on medications to slow disease progression, but this glove provides a hands-on, mechanical approach to improve daily function. Researchers are excited because this device could enhance the quality of life by directly aiding in hand movements, potentially offering more immediate improvements in dexterity and independence. Unlike medications that take time to show effects, this glove could provide noticeable benefits with just 20 minutes of use each day.

What evidence suggests that this robotic glove is effective for ALS?

Studies have shown that a robotic-assisted glove can greatly improve hand movement in people with ALS. Research indicates that this type of robotic assistance can enhance both measurable factors, like grip strength, and personal experiences, such as overall quality of life. One study found that these devices improve the range of motion and make it easier for ALS patients to engage in daily activities. This trial will evaluate the effectiveness of the robotic glove intervention, with participants using the glove 5 days a week for 20 minutes each day. These findings offer hope that the glove could provide real benefits for those dealing with ALS.12467

Who Is on the Research Team?

KC

Kayla Chomko, PT, DPT

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

This trial is for individuals with ALS who have a caregiver to assist them, experience fine motor or grip strength deficits in at least one hand, and meet specific strength criteria. They must not have changed their medication dose in the last 30 days.

Inclusion Criteria

My neurologist diagnosed me with ALS.
I have someone to help me use a robotic glove.
I have trouble with hand movements or gripping with at least one hand.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment and Training

Participants undergo baseline assessments and receive training on the use of the robotic glove

1 day
1 visit (in-person)

Robotic Glove Intervention

Participants use the robotic glove for 20 minutes daily, 5 days a week for 8 weeks

8 weeks
3 visits (in-person), 2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Robotic Glove

Trial Overview

The study tests if using a robotic glove can improve quality of life, grip strength, and fine motor control in ALS patients. It involves clinic visits for assessments and daily use of the glove at home for 8 weeks with Telehealth check-ins.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Robotic Glove InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials
103
Recruited
12,000+

Citations

Impact of Robotic Glove Use on Quality of Life, Grip ...

The goal of this clinical trial is to determine the impact of robotic glove use on quality of life, grip strength and fine motor control in ...

Occupational therapy using a robotic-assisted glove ...

The robotic rehabilitation significantly improved both objective and subjective scores in amyotrophic lateral sclerosis. •. The resting-state functional ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36411175/

Occupational therapy using a robotic-assisted glove ...

Conclusion: The occupational therapy using RAG displayed improved hand dexterity. The enhanced functional connectivities around the sensorimotor ...

Restoring arm function with a soft robotic wearable for ...

So far, the focus for assistive soft robotic wearables has been on demonstrating reduced muscle activity in healthy individuals, with few ...

Assistive Technology in ALS - Harvard Biodesign Lab

The devices showed various benefits, including improved range of motion, function, and partic- ipation in daily activities.

Acceptance of Enhanced Robotic Assistance Systems in ...

This trial aims to evaluate the acceptance of technology, in general, and of robotic arm assistance among people with ALS.

Assistive Robots for Patients With Amyotrophic Lateral Sclerosis

These robot arms provide 6 df (7 df including the gripper) and are characterized by very slim and lightweight design [Petrich L, Jin J, Dehghan ...