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
|
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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 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 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

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 |
- 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
- 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 ]

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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

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
Germany | |
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b | |
Erlangen, Germany, 91058 |
Principal Investigator: | Klaus Pfeifer, Prof. Dr. | Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport |
Publications of Results:
Other 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 |
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 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 |