Portable Rehabilitation Device for Spasticity

Recruiting at 1 trial location

Overseen By Gregory Roytman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Minors, Vulnerable populations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 20 minutes

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new portable device, the PoRi Device, designed to assist individuals with spasticity, which causes stiff and tight muscles, particularly in the hand. The device reduces muscle tightness by moving the fingers. Participants will use the device in a single 20-minute session. The trial seeks individuals who have difficulty moving their fingers due to paralysis or other motor issues. Those with hand stiffness and difficulty moving fingers may find this trial suitable. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for hand spasticity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for reducing hand spasticity?

Research has shown that the PoRi device, designed to alleviate hand stiffness, is generally safe. Studies on similar devices, such as exoskeletons, indicate safety, though some users might experience skin irritation or muscle issues. The PoRi device is light and easy to use, enhancing patient comfort. Simple tests suggest it is safe and well-tolerated, enabling independent use. While the safety data is encouraging, informing a healthcare provider about any discomfort or side effects experienced during use is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PoRi Device is unique because it offers a portable, hands-on approach to managing hand spasticity. Unlike standard treatments like oral medications, injections, or traditional physical therapy, this device directly extends and flexes finger muscles in a single session. Researchers are excited about this method because it provides immediate muscle engagement and could potentially offer faster and more targeted relief, all while being easy to use in a clinical setting.

What evidence suggests that this device is effective for spasticity?

Studies have shown that devices like the PoRi, which assist in moving the hands of patients with muscle tightness, can reduce this tightness. Early research suggests that the PoRi device, used by participants in this trial, helps stroke patients open their fingers. Similar treatments, such as repetitive peripheral magnetic stimulation (rPMS), have greatly reduced muscle tightness and improved movement in patients. Neuromuscular electric stimulation (NMES) has also successfully decreased muscle tightness and enhanced movement. These findings provide promising evidence for the potential effectiveness of the PoRi device in treating hand muscle tightness. ^{3 5 6 7 8}

Who Is on the Research Team?

Necolle Morgado-Vega

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals experiencing spasticity and hand cramps. Participants should be available to attend sessions at Yale New Haven Hospital's outpatient clinic or the Inpatient Rehabilitation Unit.

Inclusion Criteria

Modified Ashworth Scale (MAS) score of at least 1

I have paralysis or trouble moving my fingers.

Exclusion Criteria

I am under 18 years old.

Vulnerable populations

My fingers and wrist can't stretch to a flat position.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Treatment

Participants undergo a single 20-minute session with the PoRi device to extend and flex finger muscles

20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in muscle tone using the Modified Ashworth Scale (MAS) before and after the intervention

immediate

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PoRi Device

Trial Overview The study tests a new Portable Rehabilitation (PoRi) device designed to move the hand and potentially reduce muscle tone in patients with spasticity, during a single 20-minute session.

How Is the Trial Designed?

Group I: Hand Spasticity Experimental Treatment 1 Intervention

Each participant will have a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and data collection.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

A study involving 12 participants with acute/sub-acute spinal cord injuries showed that using powered exoskeletons for locomotor training is generally safe, although symptomatic hypotension was the most common adverse event reported.

The feasibility of using exoskeletons was demonstrated, with 54% protocol compliance and 58% of participants achieving at least minimal assistance during walking sessions, indicating potential for effective rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. Delgado, AD., Escalon, MX., Bryce, TN., et al.[2021]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06842901/feasibility-study-on-pori-device?id=871&slug=limb-spasticity

Feasibility Study on PoRi Device | Clinical Research Trial ... This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone.

2. researchgate.net researchgate.net/publication/365419905_PoRi_device_portable_hand_assessment_and_rehabilitation_after_stroke_PoRi_Ein_transportables_Gerat_zum_Einsatz_im_hauslichen_Umfeld_fr_die_Bewertung_und_Rehabilitation_der_Hand_nach_einem_Schlaganfall

PoRi device: portable hand assessment and rehabilitation ... Initial user studies indicate that the prototype can support stroke patients in extending their fingers. In further experiments targeting the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488456/

Efficacy of repetitive peripheral magnetic stimulation on upper ... The results indicate that rPMS can significantly improve upper limb motor function, ADLs, and self-care abilities in stroke patients, but its ...

4. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.115.009633

Effects of Electrical Stimulation in Spastic Muscles After ... Neuromuscular electric stimulation (NMES) has been used to reduce spasticity and improve range of motion in patients with stroke.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9679494/

Effects of repetitive peripheral magnetic stimulation on ... Previous studies have demonstrated that rPMS with single or multiple sessions can significantly reduce spasticity and increase upper limb motor ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12493139/

Development of a wrist and hand stretching device for ... The primary function of the device is to stretch and extend the spastic wrist and fingers, allowing individuals to operate it independently ...

7. withpower.com withpower.com/trial/phase-muscle-spasticity-2-2025-7e529

Portable Rehabilitation Device for Spasticity Research on similar rehabilitation devices, like exoskeletons, shows that they can be safe but may cause some side effects like skin discomfort, muscle issues, ...

8. robolab.si robolab.si/user_upload/Publications/publications/2022/Mandeljc_Applied_Sciences_22.pdf

Robotic Device for Out-of-Clinic Post-Stroke Hand Rehabilitation is simple for donning and doffing, so that the patients could do it themselves, even in case of spasticity;. • is safe, so that the device can ...