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Clinical Use of Andante SmartStep System in Gait Rehabilitation

NCT ID: NCT00268658

Last Updated: 2007-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.

Detailed Description

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To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.

Conditions

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Ankle Injuries Femoral Neck Fractures

Keywords

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Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SmartStep(tm) biofeedback device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Rehabilitation after operation
* Patient is allowed full weight bearing
* Patient is motivated and able to communicate and understands orders
* Patient is able to walk 10 meters
* Patient filled out agreement and consent form

Exclusion Criteria

* Activity limitation due to medical disorder, medications, or emotional status.
* Pain markedly obstructs gait ability
* Documented peripheral neuropathy
* Functional limitation prior to the current condition
* Premorbid, ongoing major depression or psychosis
* Multiple/pathological fractures
* Serious early complications
* Terminally ill patients
* Pregnant women
* Participation in current or recent (within 60 days prior to surgery) clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Daniel Plotkin, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Daniel Plotkin, MD

Role: primary

Other Identifiers

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sor412805ctil

Identifier Type: -

Identifier Source: org_study_id