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Stability and Balance in Locomotion Through Exercise (StaBLE)
This study has been completed.
Sponsor:
University of Erlangen-Nürnberg
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: October 4, 2016
Last verified: October 2016
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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 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:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg:
Primary Outcome Measures:
- Change from Baseline Gait Speed [ Time Frame: 8 weeks and 20 weeks ]Self selected walking speed is assessed on a 10 meter walk distance
- 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:
- 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
- Change from Baseline Mobility [ Time Frame: 8 weeks and 20 weeks ]Rivermead Mobility Index
- Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 8 weeks and 20 weeks ]
| Enrollment: | 48 |
| Study Start Date: | June 2013 |
| Study Completion Date: | June 2016 |
| Primary Completion Date: | June 2016 (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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856244
Locations
| Germany | |
| 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
Investigators
| Principal Investigator: | Klaus Pfeifer, Prof. Dr. | Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport |
More Information
Publications:
| 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: | October 4, 2016 |
Keywords provided by Prof. Dr. Klaus Pfeifer, 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 June 23, 2017