StaBLE: Stability and Balance in Locomotion Through Exercise

Sponsor

University of Erlangen-Nürnberg (Other)

Overall Status

Completed

CT.gov ID

NCT01856244

Collaborator

German Foundation for Neurology (Other), Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Behavioral: treadmill walking Device: Treadmill	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sensorimotor treadmill training specific treadmill control using oscillating platform	Behavioral: treadmill walking Device: Treadmill
Active Comparator: conventional treadmill training conventional treadmill control	Behavioral: treadmill walking Device: Treadmill

Arm

Intervention/Treatment

Experimental: sensorimotor treadmill training

specific treadmill control using oscillating platform

Behavioral: treadmill walking

Device: Treadmill

Active Comparator: conventional treadmill training

conventional treadmill control

Behavioral: treadmill walking

Device: Treadmill

Outcome Measures

Primary Outcome Measures

Change from Baseline Gait Speed [8 weeks and 20 weeks]
Self selected walking speed is assessed on a 10 meter walk distance
Change from Baseline Balance [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 Outcome Measures

Change from Baseline Gait Performance [8 weeks and 20 weeks]
Two Minute Walk Test (2MWT), Timed "up-and-go" Test, Assessment of tempo-spatial gait parameters
Change from Baseline Mobility [8 weeks and 20 weeks]
Rivermead Mobility Index
Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS) [8 weeks and 20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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