N/A
N=30
LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device
Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02968277 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: 6 Minute Walk Test — 245.2; 234.7; 233.9 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LifeWalker Upright (Device); Predicate Device (Device); Standard Rollator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Test |
245.2; 234.7; 233.9 | — |
| SECONDARY 10 Meter Walk Test |
1.00; 1.04; 1.01 | — |
| SECONDARY Baseline Modified Falls Efficacy Scale (mFES) Score: |
8.20; 7.47; 6.19 | — |
| SECONDARY Visual Analog Pain Scale (VAS) |
4.48; 3.86; 2.77 | — |
| SECONDARY User Functional Rating Scale |
7.17; 8.26; 8.58 | — |
| SECONDARY Borg Rate of Perceived Exertion |
12; 14.1; 14.1 | — |
| SECONDARY Forearm and Hand Grip |
4.8; 5.8; 5.7 | — |
Summary
The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device.
Eligibility Criteria
Inclusion Criteria
- Individuals who use a walker due to back pain or adults (over 18) who use a walker for ambulation.
- Ages from 18 to 89 years old
- Medically stable for therapy
Exclusion Criteria
- Patient weight exceeds 300 lbs
- Patient height is below 5'0" or exceeds 6'3"
- Inactive, physically unfit to fit into the device.
- Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments.
- Mini-Mental State Exam (MMSE) score below 17
- Pregnant women
- Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)
Data sourced from ClinicalTrials.gov (NCT02968277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.