Stability and Balance in Locomotion Through Exercise (StaBLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Erlangen-Nürnberg
Sponsor:
Collaborators:
Deutsche Stiftung Neurologie (DSN)
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:
NCT01856244
First received: May 8, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Parkinson's Disease
Behavioral: treadmill walking
Device: Treadmill
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensorimotor Treadmill Training to Improve Gait and Balance in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg:

Primary Outcome Measures:
  • Change from Baseline Gait Speed [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]
    Self selected walking speed is assessed on a 10 meter walk distance

  • Change from Baseline Balance [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]
    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:
  • Change from Baseline Gait Performance [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]
    Two Minute Walk Test (2MWT), Timed "up-and-go" Test, Assessment of tempo-spatial gait parameters

  • Change from Baseline Mobility [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]
    Rivermead Mobility Index

  • Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856244

Contacts
Contact: Simon Steib, Dr. 0049 91318528178 simon.steib@fau.de
Contact: Klaus Pfeifer, Prof. Dr. 0049 91318528106 klaus.pfeifer@fau.de

Locations
Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b Recruiting
Erlangen, Germany, 91058
Contact: Simon Steib, Dr.    0049 91318528178    simon.steib@fau.de   
Contact: Klaus Pfeifer, Prof. Dr.    0049 91318528106    klaus.pfeifer@fau.de   
Sub-Investigator: Simon Steib, Dr.         
Sponsors and Collaborators
University of Erlangen-Nürnberg
Deutsche Stiftung Neurologie (DSN)
Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
Investigators
Principal Investigator: Klaus Pfeifer, Prof. Dr. Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
  More Information

No publications provided

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
Study First Received: May 8, 2013
Last Updated: July 2, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg:
Parkinson's Disease
treadmill training
gait
balance
mobility

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

ClinicalTrials.gov processed this record on August 28, 2014