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

Parkinson Disease Clinical Trial

Official title:

Influence of Multiple Ratio Split-belt Treadmill on Gait Asymmetry and Motor Learning in PD Patients With Freezing of Gait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725215
• Other study ID #: S60876
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

Behavioral:
• Split-Belt Treadmill Training
One session of 6 x 5 min with 1 min intervals.

Locations

Country	Name	City	State
Belgium	Faculty of Movement and Rehabilitation Sciences (FaBeR)	Leuven
Germany	University Hospital Schleswig-Holstein	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	University of Kiel

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptation to Split/Tied Belt	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.	24 hours after training
Primary	Gait Asymmetry	Measured with 3D motion analysis system during straight line overground walking	24 hours after training
Primary	Freezing Ratio	Measured with APDM sensors during 360 degree turns	24 hours after training
Secondary	Medio-lateral Anticipatory Postural Adjustments	Measured with APDM sensors at gait initiation	24 hours after training
Secondary	Gait Speed during dual task walking	Measured with 3D motion analysis system during overground walking with an auditory Stroop task	24 hours after training