Clinical trial NCT01856244: Stability and Balance in Locomotion Through Exercise
Official title: Sensorimotor Treadmill Training to Improve Gait and Balance in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
treadmill training
gait
balance
mobility
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: German Foundation for Neurology
name: Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg
First posted: 2013-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline Gait Speed
timeFrame: 8 weeks and 20 weeks
measure: Change from Baseline Balance
timeFrame: 8 weeks and 20 weeks
Secondary outcomes:
measure: Change from Baseline Gait Performance
timeFrame: 8 weeks and 20 weeks
measure: Change from Baseline Mobility
timeFrame: 8 weeks and 20 weeks
measure: Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 8 weeks and 20 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b
Study officials:
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.