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

August 7, 2019 updated by: Alice Nieuwboer, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3001
        • Faculty of Movement and Rehabilitation Sciences (FaBeR)
  • Germany
      • Kiel, Germany, 24105
        • University Hospital Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Split-Belt Treadmill Training 1:2
Split-Belt Training with a steady ratio of 1:2.
Behavioral: Split-Belt Treadmill Training
One session of 6 x 5 min with 1 min intervals.
EXPERIMENTAL: Split-Belt Treadmill Training 3:4
Split-Belt Training with a steady ratio of 3:4.
Behavioral: Split-Belt Treadmill Training
One session of 6 x 5 min with 1 min intervals.
EXPERIMENTAL: Split-Belt Treadmill Training Changing
Split-Belt Training with changing ratios between 3:4 to 1:2.
Behavioral: Split-Belt Treadmill Training
One session of 6 x 5 min with 1 min intervals.
ACTIVE_COMPARATOR: Split-Belt Treadmill Training Tied-Belt
Split-Belt Training with tied belts.
Behavioral: Split-Belt Treadmill Training
One session of 6 x 5 min with 1 min intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adaptation to Split/Tied Belt
Time Frame: 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.
24 hours after training
Gait Asymmetry
Time Frame: 24 hours after training
Measured with 3D motion analysis system during straight line overground walking
24 hours after training
Freezing Ratio
Time Frame: 24 hours after training
Measured with APDM sensors during 360 degree turns
24 hours after training

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

University of Kiel

Investigators

  • Principal Investigator: Christian Schlenstedt, PhD, CAU Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

October 28, 2018

First Posted (ACTUAL)

October 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S60876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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