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

NCT ID: NCT03725215

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Freezing of Gait

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will randomly be assigned to 1 of 4 different split-belt treadmill paradigms. Assessments will be performed pre and post training on day 1 and once again on day 2.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Split-Belt Treadmill Training 1:2

Split-Belt Training with a steady ratio of 1:2.

Group Type EXPERIMENTAL

Split-Belt Treadmill Training

Intervention Type BEHAVIORAL

One session of 6 x 5 min with 1 min intervals.

Split-Belt Treadmill Training 3:4

Split-Belt Training with a steady ratio of 3:4.

Group Type EXPERIMENTAL

Split-Belt Treadmill Training

Intervention Type BEHAVIORAL

One session of 6 x 5 min with 1 min intervals.

Split-Belt Treadmill Training Changing

Split-Belt Training with changing ratios between 3:4 to 1:2.

Group Type EXPERIMENTAL

Split-Belt Treadmill Training

Intervention Type BEHAVIORAL

One session of 6 x 5 min with 1 min intervals.

Split-Belt Treadmill Training Tied-Belt

Split-Belt Training with tied belts.

Group Type ACTIVE_COMPARATOR

Split-Belt Treadmill Training

Intervention Type BEHAVIORAL

One session of 6 x 5 min with 1 min intervals.

Interventions

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Split-Belt Treadmill Training

One session of 6 x 5 min with 1 min intervals.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kiel

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Alice Nieuwboer

Senior Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alice Nieuwboer, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Christian Schlenstedt, PhD

Role: PRINCIPAL_INVESTIGATOR

CAU Kiel

Locations

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Faculty of Movement and Rehabilitation Sciences (FaBeR)

Leuven, , Belgium

Site Status

University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

Countries

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Belgium Germany

References

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Seuthe J, D'Cruz N, Ginis P, Becktepe JS, Weisser B, Nieuwboer A, Schlenstedt C. The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait. Neurorehabil Neural Repair. 2020 Oct;34(10):954-963. doi: 10.1177/1545968320953144. Epub 2020 Sep 17.

Reference Type DERIVED
PMID: 32940131 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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S60876

Identifier Type: -

Identifier Source: org_study_id

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