Stability and Balance in Locomotion Through Exercise

Parkinson's Disease Clinical Trial

— StaBLE  

Official title:

Sensorimotor Treadmill Training to Improve Gait and Balance in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856244
• Other study ID #: DSN-0613
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2013
• Last updated: October 4, 2016
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• treadmill walking

Device:
• Treadmill

Locations

Country	Name	City	State
Germany	Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b	Erlangen

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg, Deutsche Stiftung Neurologie (DSN)

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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 Aug 26;50:102-108. doi: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Gait Speed	Self selected walking speed is assessed on a 10 meter walk distance	8 weeks and 20 weeks	No
Primary	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	8 weeks and 20 weeks	No
Secondary	Change from Baseline Gait Performance	Two Minute Walk Test (2MWT), Timed "up-and-go" Test, Assessment of tempo-spatial gait parameters	8 weeks and 20 weeks	No
Secondary	Change from Baseline Mobility	Rivermead Mobility Index	8 weeks and 20 weeks	No
Secondary	Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)		8 weeks and 20 weeks	No