NCT01006967

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

October 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 16, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

5.7 years

First QC Date

October 27, 2009

Results QC Date

April 5, 2018

Last Update Submit

July 13, 2018

Conditions

Gait Disorders

Keywords

balanceaccidental fallsphysical therapyActiveStepolder adults

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects Reporting Any Fall

    3 months

  • Number of Subjects Reporting a Fall-related Injury

    3 months

Secondary Outcomes (4)

  • Change in Timed Up and Go From Baseline

    End of Treatment

  • Change in Berg Balance Scale From Baseline

    End of Treatment

  • Change in Dynamic Gait Index From Baseline

    End of Treatment

  • Change in Activities-specific Balance Confidence From Baseline

    End of Treatment

Study Arms (2)

ActiveStep

ACTIVE COMPARATOR

Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance

Device: ActiveStep Treadmill

Standard physical therapy

ACTIVE COMPARATOR

Subjects will receive a standard physical therapy program for gait and balance.

Other: Physical Therapy

Interventions

ActiveStep TreadmillDEVICE

The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.

ActiveStep
Physical TherapyOTHER

Standard program of physical therapy for gait and balance

Standard physical therapy

Eligibility Criteria

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

You may qualify if:

  • Age 65 and over
  • Referred to physical therapy for balance training

You may not qualify if:

  • Age \< 65
  • Unable to use treadmill
  • Severe vertigo
  • Not a candidate for gait/balance PT
  • Not competent to consent to research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Spaulding Rehabilitation Hospital

Salem, Massachusetts, 01970, United States

Location

Concord Hospital Rehabilitation Services

Epsom, New Hampshire, 03234, United States

Location

Cheshire Medical Center - Farnum Rehabilitation Center

Keene, New Hampshire, 03431, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Elliot Hospital

Manchester, New Hampshire, 03104, United States

Location

South Shore Neurological Associates

Patchogue, New York, 11722, United States

Location

White River Junction Veterans Administration Medical Center

White River Junction, Vermont, 05009, United States

Location

Related Publications (2)

  • Lurie JD, Zagaria AB, Ellis L, Pidgeon D, Gill-Body KM, Burke C, Armbrust K, Cass S, Spratt KF, McDonough CM. Surface Perturbation Training to Prevent Falls in Older Adults: A Highly Pragmatic, Randomized Controlled Trial. Phys Ther. 2020 Jul 19;100(7):1153-1162. doi: 10.1093/ptj/pzaa023.

    PMID: 31998949DERIVED

  • Lurie JD, Zagaria AB, Pidgeon DM, Forman JL, Spratt KF. Pilot comparative effectiveness study of surface perturbation treadmill training to prevent falls in older adults. BMC Geriatr. 2013 May 16;13:49. doi: 10.1186/1471-2318-13-49.

    PMID: 23678970DERIVED

MeSH Terms

Conditions

Mobility Limitation

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Results Point of Contact

Title
Jon D. Lurie, MD, MS
Organization
Geisel School of Medicine at Dartmouth
jon.d.lurie@dartmouth.edu
603 653-3575

Study Officials

  • Jon D Lurie, M.D., M.S.

    Dartmouth College

    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 INVESTIGATOR
PI Title
Professor of Medicine (General Internal Medicine)

Study Record Dates

First Submitted

October 27, 2009

First Posted

November 3, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

July 16, 2018

Results First Posted

July 16, 2018

Record last verified: 2018-07

Locations

US(8)