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

NCT ID: NCT00964652

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-12-31

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.

Conditions

Parkinson´s Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD Group

Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.

Group Type: EXPERIMENTAL

Treadmill walking training with additional body load

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 51 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Universidade Federal de Sao Carlos

Locations

Universidade Federal de São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

234/2007

Identifier Type: -

Identifier Source: org_study_id