Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease

August 24, 2009 updated by: Universidade Federal de Sao Carlos

Background: Studies about the effects of walking training with additional body load in Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during treadmill walking improves reflex activity and leg extensor muscle activity, which are impaired in subjects with PD.

Purpose: The purpose of this study was to assess the effects of treadmill walking training with additional body load on the ground reaction forces, spatiotemporal, and kinematic variables of the gait of subjects with moderate PD.

Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were conducted in a movement analysis laboratory, and at the rehabilitation unit of the University, respectively.

Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances.

Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10% increase of normal body mass. Phase B included 6 weeks of conventional physical therapy.

Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic variables during overground walking, at baseline and after each phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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

  • Brazil
    • SP
      • São Carlos, SP, Brazil
        • Universidade Federal de Sao Carlos

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

51 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic PD (previously diagnosed by one specialist physician,)
  • Hoehn and Yahr (H-Y) stages 2 through 3,
  • Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level) and,
  • Capacity to ambulate independently for at least 10 meters.

Exclusion Criteria:

  • Change medication (dopaminergic) during the study period,
  • Use treadmill for at least six months prior to the study, and
  • Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the performance of the training.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD Group
Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.
Other: Treadmill walking training with additional body load

The training program was divided into three phases (A1-B-A2):

treadmill training with additional body load (A1), control condition (conventional physical therapy) (B). and treadmill training with additional body load again (A2). Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant increase in propulsive forces, stride length, speed, maximum hip extension during stance were observed after the training program.
Time Frame: 4 times, once before treatment, and 3 after each treatment phase.
4 times, once before treatment, and 3 after each treatment phase.

Collaborators and Investigators

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

Sponsor

Universidade Federal de Sao Carlos

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

August 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 234/2007

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.

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