The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.

April 3, 2017 updated by: Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training with visual and auditory cues is useful in improving the gait's parameters in patients in early-moderate stages of disease. No data are available about the effectiveness of this training in those subjects in advanced stages of PD. The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

150 patients with PD in early-moderate and advanced stages of disease (50 in H&Y stage 2, group 1, 50 in H&Y stage 3, group 2 and 50 in H&Y stage 4, group 3) were enrolled. All patients underwent an intensive treatment: 20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Como
      • Gravedona ed Uniti, Como, Italy, 22015
        • Recruiting
        • Ospedale Generale di Zona Moriggia Pelascini
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: treadmill training
20-minutes treadmill training per day, 6 times a week, for 4 weeks
Procedure: treadmill training with cues
20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of step
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2014

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 3, 2016

First Posted (ESTIMATE)

April 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • treadmill and PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe