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

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.

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.

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:

1. Hand width: determined by the base of the 1st metacarpal to distal end of 5th metacarpal
2. Hand length: determined by lunate to distal end of distal phalanx of digit 3
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:

1. Amyotrophic Lateral Sclerosis Quality of Lift Short Form (ALS QOL short form)
2. EuroQOL-5D (EQ-5D)
3. Grip Strength
4. 9 Hole PEG test
5. Tip-to-Tip pinch strength
6. Palmar pinch strength
7. Key pinch strength
8. 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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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