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Stability and Balance in Locomotion Through Exercise (StaBLE)

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ClinicalTrials.gov Identifier: NCT01856244
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : October 5, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

Persons with Morbus Parkinson commonly develop gait and balance disorders leading to dependence, loss of mobility and a high risk of falling.

This study investigates the effectiveness of a sensorimotor treadmill intervention to improve walking and balance abilities in persons with early stages of Parkinson's disease. The sensorimotor treadmill training is conducted on a special treadmill device which is challenging the participants by small oscillations. This intervention, which is supposed to simulate walking on natural, uneven surfaces, is compared to a conventional treadmill training.

Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and balance abilities as compared to conventional treadmill exercise.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: treadmill walking Device: Treadmill Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensorimotor Treadmill Training to Improve Gait and Balance in Parkinson's Disease
Study Start Date : June 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: sensorimotor treadmill training
specific treadmill control using oscillating platform
Behavioral: treadmill walking Device: Treadmill
Active Comparator: conventional treadmill training
conventional treadmill control
Behavioral: treadmill walking Device: Treadmill

Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline Gait Speed [ Time Frame: 8 weeks and 20 weeks ]
    Self selected walking speed is assessed on a 10 meter walk distance

  2. Change from Baseline Balance [ Time Frame: 8 weeks and 20 weeks ]
    Mini - Balance Evaluation Systems Test (Mini - BESTest), Postural Sway in the Romberg Test with eyes open and eyes closed for 30 seconds

Secondary Outcome Measures :
  1. Change from Baseline Gait Performance [ Time Frame: 8 weeks and 20 weeks ]
    Two Minute Walk Test (2MWT), Timed "up-and-go" Test, Assessment of tempo-spatial gait parameters

  2. Change from Baseline Mobility [ Time Frame: 8 weeks and 20 weeks ]
    Rivermead Mobility Index

  3. Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 8 weeks and 20 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parkinson's disease stage 1-3 Hoehn and Yahr
  • United Parkinson Disease Rating Scale (UPDRS) 'gait' or 'postural stability' subscore of 1 or more
  • Ability to stand unaided and walk without an assistive device
  • Stable medication during the study period

Exclusion Criteria:

  • On-off and wearing-off phenomena
  • Unstable medical or psychiatric illness
  • Clinically relevant cardiovascular or orthopaedic disease
  • Severe polyneuropathy
  • Cognitive impairment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856244

Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
Erlangen, Germany, 91058
Sponsors and Collaborators
University of Erlangen-Nürnberg
Deutsche Stiftung Neurologie (DSN)
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Principal Investigator: Klaus Pfeifer, Prof. Dr. Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
More Information

Responsible Party: Prof. Dr. Klaus Pfeifer, Prof. Dr., University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT01856244     History of Changes
Other Study ID Numbers: DSN-0613
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg:
Parkinson's Disease
treadmill training

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases