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Completed

NCT Number: NCT03725215

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Movement and Rehabilitation Sciences (FaBeR), Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Split-belt treadmill training

Behavioral

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

Primary outcomes

  1. 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.

  2. Gait Asymmetry

    Time frame: 24 hours after training

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

  3. Freezing Ratio

    Time frame: 24 hours after training

    Measured with APDM sensors during 360 degree turns

Secondary outcomes

  1. Medio-lateral Anticipatory Postural Adjustments

    Time frame: 24 hours after training

    Measured with APDM sensors at gait initiation

  2. 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • University of Kiel

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2018
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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