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

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT00964652
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Parkinson´s Disease
 Other: Treadmill walking training with additional body load

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   51 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964652

Locations
Brazil
Universidade Federal de São Carlos
São Carlos, SP, Brazil
Sponsors and Collaborators
Universidade Federal de Sao Carlos
  More Information

No publications provided

Responsible Party: Nadiesca Taisa Filippin, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT00964652     History of Changes
Other Study ID Numbers: 234/2007
Study First Received: August 24, 2009
Last Updated: August 24, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Sao Carlos:
treadmill
body load
Parkinson's disease
gait

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 23, 2013