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Clinical Trials/NCT01856244
NCT01856244
Completed
Phase 1

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

University of Erlangen-Nürnberg1 site in 1 country48 target enrollmentJune 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Erlangen-Nürnberg
Enrollment
48
Locations
1
Primary Endpoint
Change from Baseline Gait Speed
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Klaus Pfeifer

Prof. Dr.

University of Erlangen-Nürnberg

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)(8 weeks and 20 weeks)
  • Change from Baseline Gait Performance(8 weeks and 20 weeks)
  • Change from Baseline Mobility(8 weeks and 20 weeks)

Study Sites (1)

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