Stability and Balance in Locomotion Through Exercise

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: treadmill walking; Device: Treadmill

• Registration Number: NCT01856244
• Lead Sponsor: University of Erlangen-Nürnberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Study Start: 2013-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sensorimotor treadmill training	Treadmill	specific treadmill control using oscillating platform
conventional treadmill training	treadmill walking	conventional treadmill control
conventional treadmill training	Treadmill	conventional treadmill control
sensorimotor treadmill training	treadmill walking	specific treadmill control using oscillating platform

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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