Amyotrophic Lateral Sclerosis (ALS)NCT07298486
Impact of Robotic Glove Use on Quality of Life, Grip Strength and Fine Motor Control in ALS
A study testing Robotic Glove Use in people with Amyotrophic Lateral Sclerosis (ALS), run by Nova Southeastern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Robotic Glove Use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nova Southeastern University, David and Cathy Husman Neuroscience Institute
Davie, Florida, 33314
About this study
Official title: Impact of Robotic Glove Use on Quality of Life, Grip Strength and Fine Motor Control in ALS: A Pilot Study
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.
Read more
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.
Read the detailed description
The primary aim of this study is to determine the impact of robotic glove use on quality of life, grip strength and fine motor control in participants with ALS. The study population includes 5 participants with a diagnosis of ALS, aged 18-99.
Once consent and enrollment is complete, the participant will be measured for their robotic glove size on day of enrollment. The robotic glove is a rehabilitation device that fits over the participants fingers and is secured through velcro straps. It delivers passive range of motion through an air pump that facilitates finger flexion and extension.
Measurements will be performed with a standard tape measure. The following 3 measurements will be taken of the participants affected hand:
- Hand width: determined by the base of the 1st metacarpal to distal end of 5th metacarpal
- Hand length: determined by lunate to distal end of distal phalanx of digit 3
- Middle finger circumference: determined by the circumference of the distal end of proximal phalanx of digit
The proper size robotic glove will be obtained and the BASE clinic visit will be scheduled.
Each participant will then attend three (3) in=person clinic visits and participate in two (2) telehealth visits. The clinic visits will take place at three time points: baseline (BASE), 4 weeks after the start date (4W), and post-intervention at 8 weeks (POST). The BASE visit is expected to last 60 minutes. The 4W and POST visits are expected to last 30 minutes.
Outcome measures that will be assessed at each in person clinic visit include:
- Amyotrophic Lateral Sclerosis Quality of Lift Short Form (ALS QOL short form)
- EuroQOL-5D (EQ-5D)
- Grip Strength
- 9 Hole PEG test
- Tip-to-Tip pinch strength
- Palmar pinch strength
- Key pinch strength
- Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) and its Gross motor and fine motor sub-scales (GMS) (FMS)
BASE visit:
The Base visit will consist of above mentioned assessments followed by training of both patient and caregiver on how to don and doff the robotic glove. The PI and/or study team will complete the training, followed by monitoring the patient and caregiver successfully applying the Robotic glove. The PI will manually set the robotic glove for passive mode with a 6 second on time and 6 second off time. Once the participant and caregiver are able to successfully demonstrate application and removal of the robotic glove, including powering on and off the robotic glove, the robotic glove intervention will commence.
ROBOTIC GLOVE INTERVENTION: 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. The PI and/or study team member 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 Co-PI will be available for any questions via iPhone or e-mail throughout this time period.
Telehealth Visit #1 (TH1):
This visit will commence on day 2 and will take approximately 30 minutes. A telehealth appointment will be set up with the participant and their caregiver 24 hours after the baseline visit. This will consist of synchronous video and audio via the Zoom application. The PI and/or Co-PI 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.
4W visit: The 4W visit will consist of above mentioned assessments (#1-8) as previously described in the BASE visit and will be completed in person. This is expected to last 30 minutes
Telehealth Visit #2 (TH2):
This visit will commence 24 hours after visit 4W and will mimic TH1.
POST visit:
This will occur during week 8 once all 40 intervention sessions have been completed. The participant and caregiver will be brought in to the clinic and assessments 1-8 will be completed.
This will conclude the study intervention.
Weekly telephone calls will be conducted by study personnel to ensure compliance with the protocol, the robotic glove is working properly and answer any questions the participant or caregiver may have.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Robotic Glove Use
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Glove UseDevice
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 group | Role | What they receive |
|---|---|---|
| Robotic Glove Intervention | Experimental | Participants with initiate robotic glove use 5 days / week , 1x/day for 20 minutes Receives: Device: Robotic Glove Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (7)
EuroQOL-5D
a standardized, patient-reported outcome measure used to assess health-related quality of life. It evaluates five key dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated by level of severity. It also includes a visual analog scale (VAS) where patients rate their overall health from 0 to 100.
Measured: Baseline, 4 weeks and 8 weeks
Grip Strength
Grip strength is measured in pounds utilizing a handheld dynamometer. The participant will be asked to perform maximum grip strength by squeezing a handheld dynamometer over 3 seconds, 3 reps and the average will be taken.
Measured: Baseline, 4 weeks, 8 weeks
Finger tip to tip pinch strength
Fingertip-to-tip pinch strength is measured by having the patient press the tip of their thumb and the tip of their index finger together against a pinch gauge. The patient applies maximal pressure, and the device records the force generated. The participant will be asked to complete this 3 times and the average will be taken.
Measured: baseline, 4 weeks, 8 weeks
Palmar pinch strength
Palmar pinch strength (also called three-jaw chuck pinch) measures the force generated when the thumb presses against the pads of the index and middle fingers. Using a pinch gauge, the participant is asked to squeeze as firmly as possible. Three trials are performed, and the average is recorded. This measure reflects the ability to perform everyday tasks requiring precision and control, such as holding a key, buttoning clothes, or picking up small objects.
Measured: Baseline, 4 weeks and 8 weeks
Key Pinch Strength
This test reflects functional hand strength used in tasks like turning a key, gripping a card, or opening a door. Using a pinch gauge, the participant is asked to place the gauge between the thumb pad and side of the index finger and pinch as hard as possible. 3 trials are performed and the average force is recorded.
Measured: Baseline, 4 weeks and 8 weeks
9 Hole PEG test
A standardized assessment of finger dexterity and fine motor coordination. The participant is asked to place nine pegs into nine holes and then remove them as quickly as possible, using their affected hand. The time taken to complete the task is recorded. Faster times indicated improved manual dexterity.
Measured: Baseline, 4 weeks and 8 weeks
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
It evaluates 12 items across four domains: bulbar (speech, swallowing), fine motor (handwriting, dressing), gross motor (walking, climbing stairs), and respiratory function (breathing, dyspnea).
Each item is scored from 0 (worst) to 4 (normal), giving a total score from 0 to 48, with higher scores indicating better function. It's used to track disease progression and assess response to treatments.
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start9 Feb 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kayla Chomko, Nova Southeastern University
- Investigators
- Kayla Chomko, PT, DPT, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298486
- Sponsor's protocol ID
- 2025-320-NSU
- Other IDs
- 337263
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All 5 participants baseline assessments, 4 week assessments and post assessments will be shared.
Publications
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.
PubMed 30028537Hayden 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.
PubMed 35612658Wang 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.
PubMed 36712422Yamakawa 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.
PubMed 36411175
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Robotic Glove Use on Quality of Life, Grip Strength and Fine Motor Control in ALS: A Pilot Study
- ClinicalTrials.gov ID
- NCT07298486
- Acronym / sponsor ID
- 2025-320-NSU
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this study is to determine the impact of robotic glove use on quality of life, grip strength and fine motor control in participants with ALS. The study population includes 5 participants with a diagnosis of ALS, aged 18-99.
Once consent and enrollment is complete, the participant will be measured for their robotic glove size on day of enrollment. The robotic glove is a rehabilitation device that fits over the participants fingers and is secured through velcro straps. It delivers passive range of motion through an air pump that facilitates finger flexion and extension.
Measurements will be performed with a standard tape measure. The following 3 measurements will be taken of the participants affected hand:
- Hand width: determined by the base of the 1st metacarpal to distal end of 5th metacarpal
- Hand length: determined by lunate to distal end of distal phalanx of digit 3
- Middle finger circumference: determined by the circumference of the distal end of proximal phalanx of digit
The proper size robotic glove will be obtained and the BASE clinic visit will be scheduled.
Each participant will then attend three (3) in=person clinic visits and participate in two (2) telehealth visits. The clinic visits will take place at three time points: baseline (BASE), 4 weeks after the start date (4W), and post-intervention at 8 weeks (POST). The BASE visit is expected to last 60 minutes. The 4W and POST visits are expected to last 30 minutes.
Outcome measures that will be assessed at each in person clinic visit include:
- Amyotrophic Lateral Sclerosis Quality of Lift Short Form (ALS QOL short form)
- EuroQOL-5D (EQ-5D)
- Grip Strength
- 9 Hole PEG test
- Tip-to-Tip pinch strength
- Palmar pinch strength
- Key pinch strength
- Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) and its Gross motor and fine motor sub-scales (GMS) (FMS)
BASE visit:
The Base visit will consist of above mentioned assessments followed by training of both patient and caregiver on how to don and doff the robotic glove. The PI and/or study team will complete the training, followed by monitoring the patient and caregiver successfully applying the Robotic glove. The PI will manually set the robotic glove for passive mode with a 6 second on time and 6 second off time. Once the participant and caregiver are able to successfully demonstrate application and removal of the robotic glove, including powering on and off the robotic glove, the robotic glove intervention will commence.
ROBOTIC GLOVE INTERVENTION: 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. The PI and/or study team member 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 Co-PI will be available for any questions via iPhone or e-mail throughout this time period.
Telehealth Visit #1 (TH1):
This visit will commence on day 2 and will take approximately 30 minutes. A telehealth appointment will be set up with the participant and their caregiver 24 hours after the baseline visit. This will consist of synchronous video and audio via the Zoom application. The PI and/or Co-PI 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.
4W visit: The 4W visit will consist of above mentioned assessments (#1-8) as previously described in the BASE visit and will be completed in person. This is expected to last 30 minutes
Telehealth Visit #2 (TH2):
This visit will commence 24 hours after visit 4W and will mimic TH1.
POST visit:
This will occur during week 8 once all 40 intervention sessions have been completed. The participant and caregiver will be brought in to the clinic and assessments 1-8 will be completed.
This will conclude the study intervention.
Weekly telephone calls will be conducted by study personnel to ensure compliance with the protocol, the robotic glove is working properly and answer any questions the participant or caregiver may have.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Glove Intervention | Experimental | Device: Robotic Glove UseParticipants with initiate robotic glove use 5 days / week , 1x/day for 20 minutes |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Glove UseThe 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. | Device | Robotic Glove Intervention |
Primary outcome
ALS-Specific Quality of Life Questionnaire - Short Form
Time frame: Baseline, 4 weeks, 8 weeks
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.
7 secondary outcomes
EuroQOL-5D
Time frame: Baseline, 4 weeks and 8 weeks
Grip Strength
Time frame: Baseline, 4 weeks, 8 weeks
Finger tip to tip pinch strength
Time frame: baseline, 4 weeks, 8 weeks
Palmar pinch strength
Time frame: Baseline, 4 weeks and 8 weeks
Key Pinch Strength
Time frame: Baseline, 4 weeks and 8 weeks
9 Hole PEG test
Time frame: Baseline, 4 weeks and 8 weeks
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Time frame: Baseline, 4 weeks and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 30028537Felgoise 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.
- Background: PubMed 35612658Hayden 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.
- Background: PubMed 36712422Wang 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.
- Background: PubMed 36411175Yamakawa 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.
- Individual participant dataSharing planned: Yes. All 5 participants baseline assessments, 4 week assessments and post assessments will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kayla Chomko, PT, DPT principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Glove Use in people with Amyotrophic Lateral Sclerosis (ALS), run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS-Specific Quality of Life Questionnaire - Short Form (time frame: Baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07298486, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.