Motor Adaptation to Split-Belt Treadmill in Parkinson's Disease

Not Applicable

Completed

• Conditions: Freezing of Gait; Parkinson Disease
• Interventions: Behavioral: Split-Belt Treadmill Training

• Registration Number: NCT03725215
• Lead Sponsor: KU Leuven

Brief Summary

Freezing of Gait (FOG) is a disabling symptom common in advanced Parkinson's Disease. FOG is an independent contributor to fall risk and is only partially relieved by medication. Parkinson's patients with FOG are known to have more difficulty with gait adaptation in their day to day environment. Further, asymmetry of gait has been implicated in FOG as these episodes are often elicited during asymmetric tasks such as turning. This study will examine the effect of a single session of split-belt treadmill walking on gait adaptation, gait symmetry and FOG as well as 24 hour retention of these effects.

Detailed Description

In this proposal, the investigators will investigate whether adapting gait to modulations imposed by a split-belt treadmill, improves walking ability and reduces FOG. The investigators will test the hypothesis that motor adaptation deficits underlie FOG and that these problems are modifiable with training. To address these suppositions, the investigators propose a multi-centric study conducted in two research labs with expertise in split-belt gait analysis and FOG: University of Leuven (KUL) and Christian-Albrechts-University Kiel (CAUK). As freezers have been shown to have more difficulty with consolidation of motor learning, the investigators aim in study I (pilot phase) to first understand which split-belt parameters are optimal for training gait flexibility and lead to consolidated gains in daily walking. For this study, the investigators will recruit 60 freezers and 60 healthy controls, pooled across centers, and manipulate different split-belt conditions in one learning and retention session.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-10-28
• Study First Posted: 2018-10-30
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Diagnosis of Parkinson's Disease as per the UK Parkinson's Disease Society Brain Bank Criteria
• Classification as a Freezer with the New Freezing of Gait Questionnaire (score > 0)
• Ability to walk at least 5 min. without any aid
• Stable anti-parkinsonian medication at least 1 month prior to participation

Exclusion Criteria

• Neurologic diseases other than PD
• Orthopedic injuries that could influence gait and balance
• Participation in treadmill training more than once a week
• Cognitive impairment (MMSE<24) or inability to follow test instructions
• Self-reported DBS-related postural or gait disturbances
• Cardiovascular risk factors
• Peripheral neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Split-Belt Treadmill Training 1:2	Split-Belt Treadmill Training	Split-Belt Training with a steady ratio of 1:2.
Split-Belt Treadmill Training Tied-Belt	Split-Belt Treadmill Training	Split-Belt Training with tied belts.
Split-Belt Treadmill Training Changing	Split-Belt Treadmill Training	Split-Belt Training with changing ratios between 3:4 to 1:2.
Split-Belt Treadmill Training 3:4	Split-Belt Treadmill Training	Split-Belt Training with a steady ratio of 3:4.

Primary Outcome Measures

Name	Time	Method
Adaptation to Split/Tied Belt	24 hours after training	Measured with 3D motion analysis system during treadmill walking. Patients will walk for 1.5 minutes on the treadmill that will switch from tied-to-split state and back to tied state.
Gait Asymmetry	24 hours after training	Measured with 3D motion analysis system during straight line overground walking
Freezing Ratio	24 hours after training	Measured with APDM sensors during 360 degree turns

Secondary Outcome Measures

Name	Time	Method
Medio-lateral Anticipatory Postural Adjustments	24 hours after training	Measured with APDM sensors at gait initiation
Gait Speed during dual task walking	24 hours after training	Measured with 3D motion analysis system during overground walking with an auditory Stroop task

Trial Locations

Locations (2)

Faculty of Movement and Rehabilitation Sciences (FaBeR); 🇧🇪 Leuven, Belgium

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany