Randomized ActiveStep Clinical Evaluation

NCT ID: NCT00810082

Last Updated: 2018-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fall Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Standard physical therapy for fall prevention

Group Type ACTIVE_COMPARATOR

Standard Physical Therapy for Fall Prevention

Intervention Type OTHER

Standard physical therapy for fall prevention

Group B

Physical therapy for fall prevention that includes ActiveStep

Group Type EXPERIMENTAL

ActiveStep

Intervention Type DEVICE

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.

Standard Physical Therapy for Fall Prevention

Intervention Type OTHER

Standard physical therapy for fall prevention

Interventions

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ActiveStep

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.

Intervention Type DEVICE

Standard Physical Therapy for Fall Prevention

Standard physical therapy for fall prevention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 65 or older
* Referred for balance training

Exclusion Criteria

* Age \< 65
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon D Lurie, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Richard M Greenwald, PhD

Role: PRINCIPAL_INVESTIGATOR

Simbex Corporation

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Alice Peck Day Memorial Hospital

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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TDI001

Identifier Type: -

Identifier Source: org_study_id

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