NCT03725215

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2017

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

July 12, 2018

Last Update Submit

August 7, 2019

Conditions

Parkinson DiseaseFreezing of Gait

Keywords

Split-Belt TreadmillTraining

Outcome Measures

Primary Outcomes (3)

  • 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

  • Gait Asymmetry

    Measured with 3D motion analysis system during straight line overground walking

    24 hours after training

  • Freezing Ratio

    Measured with APDM sensors during 360 degree turns

    24 hours after training

Secondary Outcomes (2)

  • Medio-lateral Anticipatory Postural Adjustments

    24 hours after training

  • Gait Speed during dual task walking

    24 hours after training

Study Arms (4)

Split-Belt Treadmill Training 1:2

EXPERIMENTAL

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

Behavioral: Split-Belt Treadmill Training

Split-Belt Treadmill Training 3:4

EXPERIMENTAL

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

Behavioral: Split-Belt Treadmill Training

Split-Belt Treadmill Training Changing

EXPERIMENTAL

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

Behavioral: Split-Belt Treadmill Training

Split-Belt Treadmill Training Tied-Belt

ACTIVE COMPARATOR

Split-Belt Training with tied belts.

Behavioral: Split-Belt Treadmill Training

Interventions

Split-Belt Treadmill TrainingBEHAVIORAL

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

Split-Belt Treadmill Training 1:2Split-Belt Treadmill Training 3:4Split-Belt Treadmill Training ChangingSplit-Belt Treadmill Training Tied-Belt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Movement and Rehabilitation Sciences (FaBeR)

Leuven, 3001, Belgium

Location

University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32940131DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alice Nieuwboer, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Christian Schlenstedt, PhD

    CAU Kiel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Professor

Study Record Dates

First Submitted

July 12, 2018

First Posted

October 30, 2018

Study Start

December 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)DE(1)