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Completed

NCT Number: NCT01856244

Stability and Balance in Locomotion Through Exercise

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b

Erlangen, 91058, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treadmill walking

Behavioral

Treadmill

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg

Other

Collaborators

  • Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
  • German Foundation for Neurology

Registry information

Official study title

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

Acronym: StaBLE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 17, 2013
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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