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

NCT07298486 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: 2025-320-NSU337263
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Amyotrophic Lateral Sclerosis; ALS; Motor Neuron Disease

Outcome Measures

Primary Outcomes (1)

• ALS-Specific Quality of Life Questionnaire - Short Form

  is a validated, disease-specific questionnaire designed to assess quality of life in individuals with ALS. It provides a concise measure of key domains such as emotional well-being, physical symptoms, social interaction, and existential concerns. The short-form version reduces patient burden while maintaining strong reliability and sensitivity to changes in health status over time.

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (7)

• EuroQOL-5D

  Baseline, 4 weeks and 8 weeks

• Grip Strength

  Baseline, 4 weeks, 8 weeks

• Finger tip to tip pinch strength

  baseline, 4 weeks, 8 weeks

• Palmar pinch strength

  Baseline, 4 weeks and 8 weeks

• Key Pinch Strength

  Baseline, 4 weeks and 8 weeks

Study Arms (1)

Robotic Glove Intervention

EXPERIMENTAL

Participants with initiate robotic glove use 5 days / week , 1x/day for 20 minutes

Device: Robotic Glove Use

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.

Robotic Glove Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically possible, probable or definite amyotrophic lateral sclerosis by the treating neurologist
• Have a caregiver that is willing and present to assist with application of robotic glove
• Reports fine motor deficits or grip strength deficits in at least 1 hand
• Demonstrates \> or = 3 lbs. of Grip strength as measured by a dynamometer on affected hand AND/OR Demonstrates Fine motor deficits and has \> or = 1 lb. of pinch strength (tip to tip, three jaw chuck, or lateral key pinch) as measured by pinch gauge dynamometer
• Demonstrates a loss of at least 3 lbs. of Grip strength OR 1lb. of pinch strength over a minimum of 1 month period in affected hand
• Stable dose of efficacious medications for 30 days.

You may not qualify if:

• History of Rheumatoid Arthritis
• History of Depuytren's contracture
• Open wound at affected hand where robotic glove will be placed
• History of Trigger Finger
• Complete loss of sensation at the affected hand where robotic glove will be placed
• History of Carpal Tunnel Syndrome
• Prior or current use of robotic glove
• Active physical or occupational therapy treatment interventions on affected hand

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University, David and Cathy Husman Neuroscience Institute

Davie, Florida, 33314, United States

Location

Related Publications (4)

• Felgoise SH, Feinberg R, Stephens HE, Barkhaus P, Boylan K, Caress J, Clawson LL, Elman L, Goutman SA, Mccluskey L, Russell J, Tiryaki E, Weiss M, Simmons Z. Amyotrophic lateral sclerosis-specific quality of life-short form (ALSSQOL-SF): A brief, reliable, and valid version of the ALSSQOL-R. Muscle Nerve. 2018 Nov;58(5):646-654. doi: 10.1002/mus.26203. Epub 2018 Oct 19.

  PMID: 30028537 BACKGROUND

• Hayden CD, Murphy BP, Hardiman O, Murray D. Measurement of upper limb function in ALS: a structured review of current methods and future directions. J Neurol. 2022 Aug;269(8):4089-4101. doi: 10.1007/s00415-022-11179-8. Epub 2022 May 25.

  PMID: 35612658 BACKGROUND

• Wang T, Liu Z, Gu J, Tan J, Hu T. Effectiveness of soft robotic glove versus repetitive transcranial magnetic stimulation in post-stroke patients with severe upper limb dysfunction: A randomised controlled trial. Front Neurol. 2023 Jan 11;13:887205. doi: 10.3389/fneur.2022.887205. eCollection 2022.

  PMID: 36712422 BACKGROUND

• Yamakawa I, Yamada A, Sonoda Y, Wakita K, Nishioka T, Harada Y, Ogawa N, Kitamura A, Sanada M, Tani T, Imai S, Urushitani M. Occupational therapy using a robotic-assisted glove ameliorates finger dexterity and modulates functional connectivity in amyotrophic lateral sclerosis. J Clin Neurosci. 2023 Jan;107:144-149. doi: 10.1016/j.jocn.2022.11.004. Epub 2022 Nov 18.

  PMID: 36411175 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kayla Chomko, PT, DPT

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Director

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified IPD will be available 12 months after publication of the primary results and for a period of 5 years.
• Access Criteria: De-identified IPD will be shared with qualified researchers upon reasonable request, subject to review by the study investigators and execution of a data use agreement.

Locations

US (1)