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

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ClinicalTrials.gov Identifier: NCT00964652
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Universidade Federal de Sao Carlos

Tracking Information
First Submitted Date  ICMJE August 24, 2009
First Posted Date  ICMJE August 25, 2009
Last Update Posted Date August 25, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease
Official Title  ICMJE Not Provided
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson´s Disease
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: PD Group
Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.
Intervention: Other: Treadmill walking training with additional body load
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2009)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 51 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964652
Other Study ID Numbers  ICMJE 234/2007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nadiesca Taisa Filippin, Universidade Federal de Sao Carlos
Study Sponsor  ICMJE Universidade Federal de Sao Carlos
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Sao Carlos
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP