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.
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:
- 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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: George Kopiloff
- Phone Number: 3500 909-596-7733
- Email: GKopiloff@casacolina.org
Study Locations
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-
California
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Pomona, California, United States, 91767
- Casa Colina Hospital and Centers for Healthcare
-
Contact:
- George Kopiloff
- Phone Number: 3500 909-596-7733
- Email: gkopiloff@casacolina.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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Be 18 years of age or older
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Be enrolled in outpatient PT and/or OT
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Demonstrate mobility limitations appropriate for Zeen use
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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
Exclusion Criteria:
- Severe cognitive impairment
- Medical instability that would preclude participation
- Inability to safely participate in mobility assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Zeen Intervention Group
|
Participants will:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline, 2 weeks, and 4 weeks
|
|
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 |
Baseline, 2 weeks, and 4 weeks
|
|
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 |
Baseline, 2 weeks, and 4 weeks
|
|
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. |
Baseline, 2 weeks, and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction and Exertion Survey
Time Frame: Baseline, 2 weeks, and 4 weeks
|
Participants will report satisfaction with the device on a 5-point Likert Scale, or a 10-point scale, including:
Total scores range from 9 to 50, with a higher score indicating more difficulty with the device, and decreased satisfaction. |
Baseline, 2 weeks, and 4 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Trauma, Nervous System
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Spinal Cord Diseases
- Stroke
- Multiple Sclerosis
- Parkinson Disease
- Spinal Cord Injuries
Other Study ID Numbers
- ZeenMobility
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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