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

Part of paid clinical trials in Davie, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT07298486
Status
Enrolling By Invitation

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic Glove Use — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Feb 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic Glove Intervention
    Participants with initiate robotic glove use 5 days / week , 1x/day for 20 minutes

Primary Outcome Measure

ALS-Specific Quality of Life Questionnaire - Short Form [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nova Southeastern University, David and Cathy Husman Neuroscience InstituteDavieFlorida33314-

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Nova Southeastern University, David and Cathy Husman Neuroscience Institute· Davie, FL

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