ClinicalTrials.gg
Not yet recruitingNCT07923201Updated Nov 6, 2026

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.

An interventional study of Zeen Mobility Device in Stroke, Parkinson's Disease (PD) and Spinal Cord Injury, sponsored by Casa Colina Hospital and Centers for Healthcare. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Casa Colina Hospital and Centers for Healthcare · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Stroke
  • Parkinson's Disease (PD)
  • Spinal Cord Injury
  • Multiple Sclerosis
  • Orthopedic Injury
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Casa Colina Hospital and Centers for Healthcare is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
    • Grip strength ≥1 pound in at least one hand
    • Knee extension strength ≥ MMT grade 3/5
  • Be capable of providing

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive impairment
  • Medical instability that would preclude participation
  • Inability to safely participate in mobility assessments
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Zeen Intervention Group

    Device: Zeen Mobility Device

Interventions

  • DeviceZeen Mobility Device

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 2 weeks, and 4 weeks

  2. 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

    Time frame: Baseline, 2 weeks, and 4 weeks

  3. 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

    Time frame: Baseline, 2 weeks, and 4 weeks

  4. 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.

    Time frame: 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.

    Time frame: Baseline, 2 weeks, and 4 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 4 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Nov 6, 2026
StartEst.
Nov 2, 2026
Primary completionEst.
Mar 5, 2027
CompletionEst.
May 5, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923201
Lead sponsor
Casa Colina Hospital and Centers for Healthcare
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Mar 5, 2027 (estimated)
Completion
May 5, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

George Kopiloff
Contact
GKopiloff@casacolina.org
909-596-7733 ext. 3500
Emily Rosario, PhD
study director · Casa Colina Hospital and Centers for Healthcare

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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