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

Parkinson´s Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964652
• Other study ID #: 234/2007
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: August 24, 2009
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 81 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant increase in propulsive forces, stride length, speed, maximum hip extension during stance were observed after the training program.		4 times, once before treatment, and 3 after each treatment phase.	No