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

Primary Purpose

Parkinson Disease, Freezing of Gait

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Split-Belt Treadmill Training
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Split-Belt Treadmill, Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Movement and Rehabilitation Sciences (FaBeR)
  • University Hospital Schleswig-Holstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Split-Belt Treadmill Training 1:2

Split-Belt Treadmill Training 3:4

Split-Belt Treadmill Training Changing

Split-Belt Treadmill Training Tied-Belt

Arm Description

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

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

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

Split-Belt Training with tied belts.

Outcomes

Primary Outcome Measures

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.
Gait Asymmetry
Measured with 3D motion analysis system during straight line overground walking
Freezing Ratio
Measured with APDM sensors during 360 degree turns

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2018
Last Updated
August 7, 2019
Sponsor
KU Leuven
Collaborators
University of Kiel
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1. Study Identification

Unique Protocol Identification Number
NCT03725215
Brief Title
Motor Adaptation to Split-Belt Treadmill in Parkinson's Disease
Official Title
Influence of Multiple Ratio Split-belt Treadmill on Gait Asymmetry and Motor Learning in PD Patients With Freezing of Gait
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
University of Kiel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Freezing of Gait
Keywords
Split-Belt Treadmill, Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Split-Belt Treadmill Training 1:2
Arm Type
Experimental
Arm Description
Split-Belt Training with a steady ratio of 1:2.
Arm Title
Split-Belt Treadmill Training 3:4
Arm Type
Experimental
Arm Description
Split-Belt Training with a steady ratio of 3:4.
Arm Title
Split-Belt Treadmill Training Changing
Arm Type
Experimental
Arm Description
Split-Belt Training with changing ratios between 3:4 to 1:2.
Arm Title
Split-Belt Treadmill Training Tied-Belt
Arm Type
Active Comparator
Arm Description
Split-Belt Training with tied belts.
Intervention Type
Behavioral
Intervention Name(s)
Split-Belt Treadmill Training
Intervention Description
One session of 6 x 5 min with 1 min intervals.
Primary Outcome Measure Information:
Title
Adaptation to Split/Tied Belt
Description
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.
Time Frame
24 hours after training
Title
Gait Asymmetry
Description
Measured with 3D motion analysis system during straight line overground walking
Time Frame
24 hours after training
Title
Freezing Ratio
Description
Measured with APDM sensors during 360 degree turns
Time Frame
24 hours after training
Secondary Outcome Measure Information:
Title
Medio-lateral Anticipatory Postural Adjustments
Description
Measured with APDM sensors at gait initiation
Time Frame
24 hours after training
Title
Gait Speed during dual task walking
Description
Measured with 3D motion analysis system during overground walking with an auditory Stroop task
Time Frame
24 hours after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Nieuwboer, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Schlenstedt, PhD
Organizational Affiliation
CAU Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Movement and Rehabilitation Sciences (FaBeR)
City
Leuven
ZIP/Postal Code
3001
Country
Belgium
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32940131
Citation
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.
Results Reference
derived

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

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