NCT00810082

Brief Summary

The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

May 23, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

December 16, 2008

Results QC Date

October 24, 2011

Last Update Submit

April 25, 2018

Conditions

Fall Prevention

Outcome Measures

Primary Outcomes (1)

  • Participants With at Least One Fall

    Subjects who had at least one fall subsequent to treatment.

    3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Standard physical therapy for fall prevention

Other: Standard Physical Therapy for Fall Prevention

Group B

EXPERIMENTAL

Physical therapy for fall prevention that includes ActiveStep

Device: ActiveStepOther: Standard Physical Therapy for Fall Prevention

Interventions

ActiveStepDEVICE

ActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment.

Group B
Standard Physical Therapy for Fall PreventionOTHER

Standard physical therapy for fall prevention

Group AGroup B

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 or older
  • Referred for balance training

You may not qualify if:

  • Age \< 65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Alice Peck Day Memorial Hospital

Lebanon, New Hampshire, 03766, United States

Location

Results Point of Contact

Title
Dr. Jon D. Lurie, MD, MS
Organization
Dartmouth College
Jonathan D. Lurie <Jonathan.D.Lurie@hitchcock.org>
603-653-3575

Study Officials

  • Jon D Lurie, MD, MS

    Dartmouth College

    PRINCIPAL INVESTIGATOR

  • Richard M Greenwald, PhD

    Simbex Corporation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 23, 2018

Results First Posted

March 26, 2012

Record last verified: 2018-04

Locations

US(2)