What this study is
Simplified from ClinicalTrials.govTesting a mobility device (Zeen Mobility Device) to see whether it improves walking, standing, and daily function, and whether it is safe and easy to use, in adults 18 and older with mobility impairments during outpatient physical therapy. Participants compare it with their usual mobility device, such as a walker or wheelchair.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Zeen Mobility Device
Intervention · 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.
Study details
- Official title
- Evaluating Functional Outcomes and Clinical Feasibility of the Zeen Mobility Device in Outpatient Rehabilitation
- Sponsor
- Casa Colina Hospital and Centers for Healthcare
- Conditions
- Stroke · Parkinson's Disease (PD) · Spinal Cord Injury · Multiple Sclerosis · Orthopedic Injury
- Enrolling
- 20 people
- Starts
- 2026-11-02
- Est. completion
- 2027-05-05
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 informed consent
You can't join if
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCasa Colina Hospital and Centers for Healthcare
Pomona, California, United States
- George Kopiloff · Contact909-596-7733 ext. 3500gkopiloff@casacolina.org
Study team
Sponsor
Casa Colina Hospital and Centers for Healthcare
Study ID ZeenMobility
Study director
Emily Rosario, PhD
Casa Colina Hospital and Centers for Healthcare
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.