Hand SpasticityNCT06842901
Feasibility Study on PoRi Device
A study testing Portable Rehabilitation (PoRi) device in people with Hand Spasticity, run by Yale University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Spasticity
- What is being tested?
- Portable Rehabilitation (PoRi) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Modified Ashworth Scale (MAS) score of at least 1
- Participants with paralysis or motor function problems of the fingers of one or both hands.
Who cannot join
- Minors (below age 18)
- Vulnerable populations
- Inability of fingers and wrist to stretch to neutral during passive range of motion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
, Yale New Haven Hospital's Physical Medicine & Rehabilitation (PM&R) outpatient clinic
New Haven, Connecticut, 06510
Yale New Haven Hospital's Inpatient Rehabilitation Unit
New Haven, Connecticut, 06510
About this study
Official title: Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity
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.
Read the detailed description
Each patient will participate in 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 to measure the Modified Ashworth Score (MAS) before and after the intervention.
- Conditions
- Hand Spasticity
- Being tested
- Portable Rehabilitation (PoRi) device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Rehabilitation (PoRi) deviceDevice
Once the calibration is complete, the device moves the fingers to close and open the hand for a total of 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hand Spasticity | Experimental | 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. Receives: Device: Portable Rehabilitation (PoRi) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
Muscle tone is rated on a 6-point scale (0, 1, 1+, 2, 3, 4) with higher scores indicating greater spasticity.
Measured: immediately prior to intervention session and immediately following 20 minute intervention session
Secondary outcomes (1)
Device usability and accessibility survey
Device usability and accessibility will be evaluated through a patient and researcher survey.
Measured: immediately following 20 minute intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start7 Apr 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SpasticityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study population only includes participants who present for follow up management of hand spasticity at the Yale New Haven Hospital's Physical Medicine and Rehabilitation (PM\&R) outpatient clinic or who are admitted to the Yale New Haven Hospital's Inpatient Rehabilitation Unit (IRU).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Necolle Morgado-Vega, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842901
- Sponsor's protocol ID
- 2000039568
- Status last verified
- Dec 2025
- First submitted
- 18 Feb 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity
- ClinicalTrials.gov ID
- NCT06842901
- Acronym / sponsor ID
- 2000039568
- Conditions
- Hand Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 24 Feb 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.
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.
Detailed description
Each patient will participate in 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 to measure the Modified Ashworth Score (MAS) before and after the intervention.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population only includes participants who present for follow up management of hand spasticity at the Yale New Haven Hospital's Physical Medicine and Rehabilitation (PM\&R) outpatient clinic or who are admitted to the Yale New Haven Hospital's Inpatient Rehabilitation Unit (IRU).
| Arm | Type | Receives |
|---|---|---|
| Hand Spasticity | Experimental | Device: Portable Rehabilitation (PoRi) deviceEach 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Modified Ashworth Scale (MAS) score of at least 1
- Participants with paralysis or motor function problems of the fingers of one or both hands.
Key exclusion criteria (3 listed)
- Minors (below age 18)
- Vulnerable populations
- Inability of fingers and wrist to stretch to neutral during passive range of motion
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 |
|---|---|---|
| Portable Rehabilitation (PoRi) deviceOnce the calibration is complete, the device moves the fingers to close and open the hand for a total of 20 minutes. | Device | Hand Spasticity |
Primary outcome
Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
Time frame: immediately prior to intervention session and immediately following 20 minute intervention session
Muscle tone is rated on a 6-point scale (0, 1, 1+, 2, 3, 4) with higher scores indicating greater spasticity.
1 secondary outcome
Device usability and accessibility survey
Time frame: immediately following 20 minute intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Necolle Morgado-Vega principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Rehabilitation (PoRi) device in people with Hand Spasticity, run by Yale University at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility assessed using the change in Modified Ashworth Scale (MAS) score (time frame: immediately prior to intervention session and immediately following 20 minute intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.