Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease
Primary Purpose
Parkinson´s Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treadmill walking training with additional body load
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson´s Disease focused on measuring treadmill, body load, Parkinson's disease, gait
Eligibility 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.
Sites / Locations
- Universidade Federal de São Carlos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD Group
Arm Description
Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.
Outcomes
Primary Outcome Measures
Significant increase in propulsive forces, stride length, speed, maximum hip extension during stance were observed after the training program.
Secondary Outcome Measures
Full Information
NCT ID
NCT00964652
First Posted
August 24, 2009
Last Updated
August 24, 2009
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT00964652
Brief Title
Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson´s Disease
Keywords
treadmill, body load, Parkinson's disease, gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD Group
Arm Type
Experimental
Arm Description
Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.
Intervention Type
Other
Intervention Name(s)
Treadmill walking training with additional body load
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Universidade Federal de São Carlos
City
São Carlos
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
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Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease
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