Stability and Balance in Locomotion Through Exercise

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: treadmill walking
* Device: Treadmill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sensorimotor treadmill training<br>specific treadmill control using oscillating platform | Behavioral: treadmill walking<br> <br> Device: Treadmill<br> <br> |
| Active Comparator: conventional treadmill training<br>conventional treadmill control | Behavioral: treadmill walking<br> <br> Device: Treadmill<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Gait Speed | Self selected walking speed is assessed on a 10 meter walk distance | 8 weeks and 20 weeks | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from Baseline Mobility | Rivermead Mobility Index | 8 weeks and 20 weeks | 
| Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS) |  | 8 weeks and 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, treadmill training, gait, balance, mobility