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

Trial Summary

Will I have to stop taking my current medications?

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

Is the Portable Rehabilitation Device for Spasticity safe for humans?

Research on similar rehabilitation devices, like exoskeletons, shows that they can be safe but may cause some side effects like skin discomfort, muscle issues, and changes in blood pressure. It's important to have proper safety measures in place to reduce these risks. ^{1 2 3 4 5}

How does the PoRi Device treatment for spasticity differ from other treatments?

The PoRi Device is unique because it is a portable rehabilitation device specifically designed to address spasticity by providing individualized assessment and treatment through a passive exoskeletal system, which can measure motor and kinematic parameters and offer specialized rehabilitation programs. This approach contrasts with traditional manual assessments and treatments, offering a more reliable and interactive method for managing spasticity. ^{6 7 8 9 10}

What is the purpose of this trial?

This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone. The device's ability to improve spasticity before and after a 20-minute session with the device at Yale New Haven Hospital's outpatient clinic of Physical Medicine \& Rehabilitation, or the Inpatient Rehabilitation Unit.

Research Team

Necolle Morgado-Vega

Principal Investigator

Yale University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Conceptualization and Development of the Leg Activity Measure (LegA) for Patient and Carer Reported Assessment of Activity in the Paretic Leg. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Online monitoring of focal spasticity treatment with botulinum toxin in people with chronic stroke or hereditary spastic paraplegia: a feasibility study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Assessing the spastic condition of individuals with upper motoneuron involvement: validity of the myotonometer. [2006]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A novel mechatronic system for evaluating elbow muscular spasticity relying on Tonic Stretch Reflex Threshold estimation. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of a hand-stretching device during the management of spasticity in chronic hemiparetic stroke patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

New scale for assessing spasticity based on the pendulum test. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

MIT-Skywalker: A Novel Gait Neurorehabilitation Robot for Stroke and Cerebral Palsy. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

An integrated rehabilitation system for the upper limb spasticity assessment and treatment: the Rehabotics passive exoskeletal system. [2023]