Stability and Balance in Locomotion Through Exercise (StaBLE)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Behavioral: treadmill walking; Device: Treadmill	Phase 1

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from Baseline Gait Speed [ Time Frame: 8 weeks and 20 weeks ]
   Self selected walking speed is assessed on a 10 meter walk distance
2. 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 :

1. 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
2. Change from Baseline Mobility [ Time Frame: 8 weeks and 20 weeks ]
   Rivermead Mobility Index
3. Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 8 weeks and 20 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Other Publications:

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.

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
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