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Clinical Trials/NCT04176263
NCT04176263
Completed
Not Applicable

The Impact of Split-belt Treadmill Training to Modulate Freezing-related Gait Deficits and Freezing Episodes in Parkinson's Disease

KU Leuven2 sites in 2 countries52 target enrollmentAugust 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
KU Leuven
Enrollment
52
Locations
2
Primary Endpoint
Average overground 360 degree turning speed (degrees/s)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

People with Parkinson's disease (PD) often show gait impairments such as, shuffling gait, short steps and gait asymmetry and irregularity. These gait problems are already apparent in the early disease stages, having an immense effect on daily life functioning. Especially Freezing of Gait (FOG), where the patients are not able to initiate or continue their movement despite their intention to do so, is a debilitating problem. It is thought that lack of gait adaptability could be an underlying cause of FOG. With a split-belt treadmill the speed of both legs can be controlled independently, which forces participants to actively adapt their gait to the new situation. In a previous study performed at our lab, it was shown that only one session of split-belt training (SBT), in which the speed of one leg was reduced, improved gait adaptability and other gait features compared to tied-belt training (TBT). Furthermore, overground turning speed improved after only one single training session and this was even retained 24 hours later, indicating training induced long-term potentiation. Since the short-term effects of SBT are promising, the objective of this study is to investigate if 4 weeks of SBT, 3 times a week, has an effect on gait deficits found in individuals with PD, compared to 4-weeks, 3 times a week, of TBT.

Registry
clinicaltrials.gov
Start Date
August 12, 2019
End Date
May 11, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Alice Nieuwboer

Professor

KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of PD according to the recent criteria of the Movement Disorders Society made by a neurologist
  • Participants should be able to walk 5 minutes at a stretch without a walking aid
  • Hoehn \& Yahr stage II or III in the ON state of medication
  • Mini Mental State Examination score of 24 or above
  • Participants should have a steady medication schedule at the start of the study (no change in the past month).
  • To be included as a freezer participant a score of at least 1 or higher should be recorded with the New Freezing of Gait Questionnaire.

Exclusion Criteria

  • Current enrollment in another clinical study which may interfere with the conduction of this study.
  • Orthopedic injuries or other musculoskeletal problems, which could possibly effect balance and/or gait.
  • Unable or unwilling to commit to 4 weeks of training, 3 times a week
  • Participation in walking training in the month prior to the start of the study
  • Other neurological impairments (except PD)
  • Cardiovascular exercise risk factors diagnosed by a doctor

Outcomes

Primary Outcomes

Average overground 360 degree turning speed (degrees/s)

Time Frame: Change in performance between the average overground turning speed from pre to post intervention (i.e. the week after the 4-week training period ended)

Participants will be instructed to turn 360 degrees in alternating directions (clockwise/counterclockwise) for 60 seconds. The instruction is to turn as quickly as possible, while still feeling safe doing this. The average overground turning speed will be determined by the use of APDM Opal accelerometers which will be worn on both feet, wrists and the lower back.

Secondary Outcomes

  • Retention of average overground 360 degree turning speed (degrees/sec)(Change in performance from post-intervention 1 week after the 4-week training period ended (Retest 1) to retention, 5 weeks later (Retest 2).)
  • Retention of dual task average overground 360 degree turning speed (degrees/sec)(Change in performance from post-intervention 1 week after the 4-week training period ended (Retest 1) to retention, 5 weeks later (Retest 2).)
  • Average dual task overground 360 degree turning speed (degrees/sec)(Change in performance between the average overground turning speed from pre to post intervention (i.e. the week after the 4-week training period ended))

Study Sites (2)

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