Impact of Robotic Glove Use on Quality of Life, Grip Strength and Fine Motor Control in ALS

Summary

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 participants with Amyotrophic Lateral Sclerosis (ALS). This will provide valuable insights into how an assistive technology intervention can influence functional ability in daily tasks and enhance overall well-being in individuals impacted by ALS.

Participants will attend 3 in-person clinic visits (BASE, 4 week and 8 week visit) and 2 Telehealth visits (occurring 24 hours after BASE and 4 week visit). The in-person clinic visits will include assessments by either a physical or occupational therapist, followed by assessments and scoring of grip strength, various fine motor strength assessments of affected hand, fine motor coordination assessment of the affected hand and various quality of life scales.

The participant will be fitted and measured for the appropriately sized robotic glove. Once the fit is confirmed, both the participant and caregiver will receive education on how to don and doff the glove, power it on and off, and follow the study protocol. Once they demonstrate understanding and independence with these steps, the intervention will begin.

The robotic glove intervention consists of either the participant or caregiver donning the glove and powering it on. A timer will be set for 20 minutes. The participant will sit comfortably at a table with their elbow supported on the table. The PI and/or member of the study team will be present throughout the 20 minute session to monitor for discomfort, fatigue or any additional patient reported symptoms. Once the time is complete, the robotic glove will be powered off and the glove removed. The participant and caregiver will be instructed to perform this one time daily, for 5 days per week for a total of 8 weeks. The PI and study team members will be available for any questions via iPhone or e-mail throughout this time period.

The Telehealth visits will consist of synchronous video and audio via the Zoom application. The PI and/or study team members will monitor the set up, application and powering on of the Robotic Glove. The treatment of 20 minutes will be monitored and any questions the participant or caregiver have will be answered. This visit's goal is to ensure compliance and proper application of the robotic glove.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

DEVICE

Robotic Glove Use

The participant or caregiver will don the robotic glove and power on the device. A timer will be set for 20 minutes. The participant will sit comfortably at a table with their elbow supported on the table. When the time is complete, the robotic glove will be powered off and the glove removed. The PI and/or study team will be present throughout the first 2 sessions and 2 sessions midway into the 8 week study period to monitor for discomfort, fatigue or any additional patient reported symptoms. The participant will complete a total of 40 intervention sessions. Weekly telephone calls will be conducted by study team members to ensure compliance with the protocol, the robotic glove is working properly and answer any questions the participant or caregiver may have.

Sponsors & Collaborators

• Nova Southeastern University

  lead OTHER

Principal Investigators

• Kayla Chomko, PT, DPT · Nova Southeastern University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-09

Primary Completion

2026-07-30

Completion

2026-07-30

FDA Device

Yes

Countries

• United States

Study Locations