StrokeNCT07923201
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
A study testing Zeen Mobility Device in people with Stroke and Parkinson's Disease (PD), run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether the Zeen Mobility Device can improve mobility and function during outpatient rehabilitation for adults with mobility impairments. The study will also evaluate the safety of the device and how easy it is for participants and therapists to use during routine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Parkinson's Disease (PD), Spinal Cord Injury
- What is being tested?
- Zeen Mobility Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 5 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older
- Be enrolled in outpatient PT and/or OT
- Demonstrate mobility limitations appropriate for Zeen use
- Meet the following functional thresholds:
- 6MWT: 800-1800 feet
- 10MWT: 0.4-1.3 m/s
Show all 9Show fewer
- Grip strength ≥1 pound in at least one hand
- Knee extension strength ≥ MMT grade 3/5
- Be capable of providing informed consent
Who cannot join
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
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
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
George Kopiloff, 909-596-7733 ext. 3500, gkopiloff@casacolina.org
About this study
Official title: Evaluating Functional Outcomes and Clinical Feasibility of the Zeen Mobility Device in Outpatient Rehabilitation
The goal of this clinical trial is to learn whether the Zeen Mobility Device can improve mobility and function during outpatient rehabilitation for adults with mobility impairments. The study will also evaluate the safety of the device and how easy it is for participants and therapists to use during routine therapy.
The main questions it aims to answer are:
Read more
- Does using the Zeen Mobility Device improve walking, standing, transfers, and daily function compared with a participant's usual mobility device?
- Can the Zeen Mobility Device be safely incorporated into outpatient rehabilitation?
- How satisfied are participants and therapists with using the device during therapy?
Researchers will compare participants' performance using the Zeen Mobility Device with their performance using their usual mobility device, such as a walker or wheelchair. Participants will serve as their own comparison group.
Participants will:
- Complete a baseline assessment before starting the study, a midpoint assessment after 4 treatment sessions, and a final assessment after 8 treatment sessions.
- Attend 8 outpatient physical therapy sessions that include use of the Zeen Mobility Device.
- Use the Zeen Mobility Device for at least 15 minutes during each study visit for balance, mobility, walking, transfer, or standing activities selected by their therapist.
- Complete mobility and functional tests using both the Zeen Mobility Device and their usual mobility device at each assessment visit.
- Provide feedback about their experience using the device while researchers monitor safety and any device-related problems.
- Conditions
- Stroke, Parkinson's Disease (PD), Spinal Cord Injury, Multiple Sclerosis, Orthopedic Injury
- Being tested
- Zeen Mobility Device
- Medical subject headings
- Stroke, Parkinson Disease, Spinal Cord Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeen Mobility DeviceDevice
Participants will:
- Complete a baseline assessment before starting the study, a midpoint assessment after 4 treatment sessions, and a final assessment after 8 treatment sessions.
- Attend 8 outpatient physical therapy sessions that include use of the Zeen Mobility Device.
- Use the Zeen Mobility Device for at least 15 minutes during each study visit for balance, mobility, walking, transfer, or standing activities selected by their therapist.
- Complete mobility and functional tests using both the Zeen Mobility Device and their usual mobility device at each assessment visit.
- Provide feedback about their experience using the device while researchers monitor safety and any device-related problems.
| Study group | Role | What they receive |
|---|---|---|
| Zeen Intervention Group | Experimental | Not described Receives: Device: Zeen Mobility Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
The Timed Up and Go Test is a clinical tool used to evaluate functional mobility, balance, walking ability, and fall risk in older adults and individuals with neurological or musculoskeletal conditions. Scoring is measured in seconds to complete the task. Higher scores indicate worse mobility, balance, and walking ability.
Measured: Baseline, 2 weeks, and 4 weeks
10 Meter Walk Test
The 10 Meter Walk Test is an assessment of a person's walking speed as they walk 10 meters, measured in seconds. A higher score indicates worsening balance and walking capacity, and is associated with poorer home and community access and increased fall risk
Measured: Baseline, 2 weeks, and 4 weeks
6 Minute Walk Test
The 6 Minute Walk Test is an assessment of a person's walking endurance as they walk during a 6-minute period, measured in total distance walked in meters. A higher score is associated with better walking endurance and capacity, and is associated with better home and community access and decreased fall risk
Measured: Baseline, 2 weeks, and 4 weeks
Barthel Index
The Barthel Index is an ordinal clinical scale that measures a patient's level of functional independence in 10 basic activities of daily living and mobility. The scale calculates 10 items into a point total, from 0 to 100, with a higher score indicating a greater level of independence and decreased need for nursing and caregiver support.
Measured: Baseline, 2 weeks, and 4 weeks
Secondary outcomes (1)
Patient Satisfaction and Exertion Survey
Participants will report satisfaction with the device on a 5-point Likert Scale, or a 10-point scale, including:
- Comfort using the device
- Choosing to use the device during rehabilitation
- Comfort, ease of use
- Effort required for sit-to-stand transitions
- Difficulty with 90-degree turns
- Difficulty with larger turns
- Exertion during ambulation
- Hand strain during operation
- Overall fatigue during walking
Total scores range from 9 to 50, with a higher score indicating more difficulty with the device, and decreased satisfaction.
Measured: Baseline, 2 weeks, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion5 Mar 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Rosario, PhD, Study director, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923201
- Sponsor's protocol ID
- ZeenMobility
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Functional Outcomes and Clinical Feasibility of the Zeen Mobility Device in Outpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT07923201
- Acronym / sponsor ID
- ZeenMobility
- Conditions
- Stroke, Parkinson's Disease (PD), Spinal Cord Injury, Multiple Sclerosis, Orthopedic Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 6 Nov 2026 (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 learn whether the Zeen Mobility Device can improve mobility and function during outpatient rehabilitation for adults with mobility impairments. The study will also evaluate the safety of the device and how easy it is for participants and therapists to use during routine therapy.
The main questions it aims to answer are:
- Does using the Zeen Mobility Device improve walking, standing, transfers, and daily function compared with a participant's usual mobility device?
- Can the Zeen Mobility Device be safely incorporated into outpatient rehabilitation?
- How satisfied are participants and therapists with using the device during therapy?
Researchers will compare participants' performance using the Zeen Mobility Device with their performance using their usual mobility device, such as a walker or wheelchair. Participants will serve as their own comparison group.
Participants will:
- Complete a baseline assessment before starting the study, a midpoint assessment after 4 treatment sessions, and a final assessment after 8 treatment sessions.
- Attend 8 outpatient physical therapy sessions that include use of the Zeen Mobility Device.
- Use the Zeen Mobility Device for at least 15 minutes during each study visit for balance, mobility, walking, transfer, or standing activities selected by their therapist.
- Complete mobility and functional tests using both the Zeen Mobility Device and their usual mobility device at each assessment visit.
- Provide feedback about their experience using the device while researchers monitor safety and any device-related problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeen Intervention Group | Experimental | Device: Zeen Mobility Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be 18 years of age or older
- Be enrolled in outpatient PT and/or OT
- Demonstrate mobility limitations appropriate for Zeen use
- Meet the following functional thresholds:
- Be capable of providing informed consent
Key exclusion criteria (3 listed)
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
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 |
|---|---|---|
| Zeen Mobility DeviceParticipants will: * Complete a baseline assessment before starting the study, a midpoint assessment after 4 treatment sessions, and a final assessment after 8 treatment sessions. * Attend 8 outpatient physical therapy sessions that include use of the Zeen Mobility Device. * Use the Zeen Mobility Device for at least 15 minutes during each study visit for balance, mobility, walking, transfer, or standing activities selected by their therapist. * Complete mobility and functional tests using both the Zeen Mobility Device and their usual mobility device at each assessment visit. * Provide feedback about their experience using the device while researchers monitor safety and any device-related problems. | Device | Zeen Intervention Group |
Primary outcome
Timed Up and Go
Time frame: Baseline, 2 weeks, and 4 weeks
The Timed Up and Go Test is a clinical tool used to evaluate functional mobility, balance, walking ability, and fall risk in older adults and individuals with neurological or musculoskeletal conditions. Scoring is measured in seconds to complete the task. Higher scores indicate worse mobility, balance, and walking ability.
10 Meter Walk Test
Time frame: Baseline, 2 weeks, and 4 weeks
The 10 Meter Walk Test is an assessment of a person's walking speed as they walk 10 meters, measured in seconds. A higher score indicates worsening balance and walking capacity, and is associated with poorer home and community access and increased fall risk
6 Minute Walk Test
Time frame: Baseline, 2 weeks, and 4 weeks
The 6 Minute Walk Test is an assessment of a person's walking endurance as they walk during a 6-minute period, measured in total distance walked in meters. A higher score is associated with better walking endurance and capacity, and is associated with better home and community access and decreased fall risk
Barthel Index
Time frame: Baseline, 2 weeks, and 4 weeks
The Barthel Index is an ordinal clinical scale that measures a patient's level of functional independence in 10 basic activities of daily living and mobility. The scale calculates 10 items into a point total, from 0 to 100, with a higher score indicating a greater level of independence and decreased need for nursing and caregiver support.
1 secondary outcome
Patient Satisfaction and Exertion Survey
Time frame: Baseline, 2 weeks, and 4 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 6 Nov 2026.
- 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.
Emily Rosario, PhD study director
Casa Colina Hospital and Centers for Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zeen Mobility Device in people with Stroke and Parkinson's Disease (PD), run by Casa Colina Hospital and Centers for Healthcare 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 9 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: opening soon, as of the sponsor's last update on 6 Nov 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?
Contact George Kopiloff (909-596-7733 ext. 3500, GKopiloff@casacolina.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (time frame: Baseline, 2 weeks, and 4 weeks). The study lists 4 primary outcomes in all. 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 6 Nov 2026.