Stability and Balance in Locomotion Through Exercise (StaBLE)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
treadmill walking
Treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, treadmill training, gait, balance, mobility
Eligibility 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
Sites / Locations
- Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sensorimotor treadmill training
conventional treadmill training
Arm Description
specific treadmill control using oscillating platform
conventional treadmill control
Outcomes
Primary Outcome Measures
Change from Baseline Gait Speed
Self selected walking speed is assessed on a 10 meter walk distance
Change from Baseline Balance
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
Two Minute Walk Test (2MWT), Timed "up-and-go" Test, Assessment of tempo-spatial gait parameters
Change from Baseline Mobility
Rivermead Mobility Index
Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)
Full Information
NCT ID
NCT01856244
First Posted
May 8, 2013
Last Updated
October 4, 2016
Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT01856244
Brief Title
Stability and Balance in Locomotion Through Exercise
Acronym
StaBLE
Official Title
Sensorimotor Treadmill Training to Improve Gait and Balance in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
German Foundation for Neurology, Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, treadmill training, gait, balance, mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sensorimotor treadmill training
Arm Type
Experimental
Arm Description
specific treadmill control using oscillating platform
Arm Title
conventional treadmill training
Arm Type
Active Comparator
Arm Description
conventional treadmill control
Intervention Type
Behavioral
Intervention Name(s)
treadmill walking
Intervention Type
Device
Intervention Name(s)
Treadmill
Primary Outcome Measure Information:
Title
Change from Baseline Gait Speed
Description
Self selected walking speed is assessed on a 10 meter walk distance
Time Frame
8 weeks and 20 weeks
Title
Change from Baseline Balance
Description
Mini - Balance Evaluation Systems Test (Mini - BESTest), Postural Sway in the Romberg Test with eyes open and eyes closed for 30 seconds
Time Frame
8 weeks and 20 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Gait Performance
Description
Two Minute Walk Test (2MWT), Timed "up-and-go" Test, Assessment of tempo-spatial gait parameters
Time Frame
8 weeks and 20 weeks
Title
Change from Baseline Mobility
Description
Rivermead Mobility Index
Time Frame
8 weeks and 20 weeks
Title
Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
8 weeks and 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
City
Erlangen
ZIP/Postal Code
91058
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26655098
Citation
Klamroth S, Steib S, Devan S, Pfeifer K. Effects of Exercise Therapy on Postural Instability in Parkinson Disease: A Meta-analysis. J Neurol Phys Ther. 2016 Jan;40(1):3-14. doi: 10.1097/NPT.0000000000000117.
Results Reference
background
PubMed Identifier
27591395
Citation
Klamroth S, Steib S, Gassner H, Gossler J, Winkler J, Eskofier B, Klucken J, Pfeifer K. Immediate effects of perturbation treadmill training on gait and postural control in patients with Parkinson's disease. Gait Posture. 2016 Oct;50:102-108. doi: 10.1016/j.gaitpost.2016.08.020. Epub 2016 Aug 26.
Results Reference
result
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Stability and Balance in Locomotion Through Exercise
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