N/A N=506 Randomized Prevention

ActiveStep Comparative Effectiveness Trial

Gait Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01006967 ↗

Enrolled (actual)

506

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Number of Subjects Reporting Any Fall — 60; 77 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ActiveStep Treadmill (Device); Physical Therapy (Other)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Jon D. Lurie
Primary completion: Jul 2015

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	—

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.

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

View full record on ClinicalTrials.gov →

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.