Clinical trial NCT04176263: The Effect of Split-belt Treadmill Training on Gait in Parkinson's Disease
Official title: The Impact of Split-belt Treadmill Training to Modulate Freezing-related Gait Deficits and Freezing Episodes in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Keywords: Parkinson Disease
Freezing of Gait
Rehabilitation
Gait adaptation
Split-belt
Treadmill training
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Kiel
First posted: 2019-11-25
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Overground turning speed during single and dual-task will be compared between a group who will receive 4 weeks of SBT 3 times a week and a group who will receive TBT in the same dose. Participants will be randomized (1:1) to either the SBT or TBT groups by an independent researcher who is not involved in the measurements of any of the studies using a computerized random number generation technique. The randomization will be stratified based on H\&Y stage and freezing status (freezer/non-freezer).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of PD according to the recent criteria of the Movement Disorders Society made by a neurologist
2. Participants should be able to walk 5 minutes at a stretch without a walking aid
3. Hoehn \& Yahr stage II or III in the ON state of medication
4. Mini Mental State Examination score of 24 or above
5. Participants should have a steady medication schedule at the start of the study (no change in the past month).
6. 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:

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

Primary outcomes:
measure: Average overground 360 degree turning speed (degrees/s)
timeFrame: 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)
Secondary outcomes:
measure: Average dual task overground 360 degree turning speed (degrees/sec)
timeFrame: 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)
measure: Retention of average overground 360 degree turning speed (degrees/sec)
timeFrame: Change in performance from post-intervention 1 week after the 4-week training period ended (Retest 1) to retention, 5 weeks later (Retest 2).
measure: Retention of dual task average overground 360 degree turning speed (degrees/sec)
timeFrame: Change in performance from post-intervention 1 week after the 4-week training period ended (Retest 1) to retention, 5 weeks later (Retest 2).
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein (UKSH), Christian-Albrechts-University Kiel
state: Schleswig-Holstein
Study officials:
affiliation: KU Leuven
name: Alice Nieuwboer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian-Albrechts-University of Kiel
name: Christian Schlenstedt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seuthe J, D'Cruz N, Ginis P, Weisser B, Berg D, Deuschl G, Nieuwboer A, Schlenstedt C. Split-belt treadmill walking in patients with Parkinson's disease: A systematic review. Gait Posture. 2019 Mar;69:187-194. doi: 10.1016/j.gaitpost.2019.01.032. Epub 2019 Feb 7.