Stability and Balance in Locomotion Through Exercise (StaBLE)

This study is currently recruiting participants.
Verified June 2013 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: June 20, 2013
Last verified: June 2013
  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 ]
    Berg Balance Scale (BBS), Postural Sway in the Romberg Test with eyes open and eyes closed for 10 seconds


Secondary Outcome Measures:
  • Change from Baseline Gait Performance [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]
    Six Minute Walk test (SMWT), 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: 40
Study Start Date: June 2013
Estimated Primary Completion Date: May 2014 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856244

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

Locations
Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b Recruiting
Erlangen, Germany, 91058
Contact: Simon Steib    0049 91318528178    simon.steib@sport.uni-erlangen.de   
Contact: Klaus Pfeifer, Prof. Dr.    0049 91318528106    klaus.pfeifer@sport.uni-erlangen.de   
Sub-Investigator: Simon Steib         
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: June 20, 2013
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 April 22, 2014