NCT00964652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

August 24, 2009

Last Update Submit

August 24, 2009

Conditions

Keywords

treadmillbody loadParkinson's diseasegait

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

PD Group

EXPERIMENTAL

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

Other: Treadmill walking training with additional body load

Interventions

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.

PD Group

Eligibility Criteria

Age51 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations