N/A
Completed N=506
ActiveStep Comparative Effectiveness Trial
Source: ClinicalTrials.gov NCT01006967 ↗Enrolled (actual)
506
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Subjects Reporting Any Fall — 60; 77 Participants
Summary
The investigators are conducting a multi-center randomized prospective trial comparing a standard physical therapy gait and balance program with a gait and balance program that includes the ActiveStep™ treadmill.
Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to have their therapy without it. Data will be gathered from session notes, medical records and short interviews with the subjects at baseline and every 3 months over the telephone for the duration of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any Fall |
60; 77 | — |
| PRIMARY Number of Subjects Reporting a Fall-related Injury |
12; 28 | — |
| SECONDARY Change in Timed Up and Go From Baseline |
-1.96; -2.18 | — |
| SECONDARY Change in Berg Balance Scale From Baseline |
5.96; 5.79 | — |
| SECONDARY Change in Dynamic Gait Index From Baseline |
3.26; 3.74 | — |
| SECONDARY Change in Activities-specific Balance Confidence From Baseline |
11.05; 12.05 | — |
Eligibility Criteria
Inclusion Criteria
- Age 65 and over
- Referred to physical therapy for balance training
Exclusion Criteria
- Age < 65
- Unable to use treadmill
- Severe vertigo
- Not a candidate for gait/balance PT
- Not competent to consent to research
Data sourced from ClinicalTrials.gov (NCT01006967). 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. Informational only — not medical advice.