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The Effect of Split-belt Treadmill Training on Gait in Parkinson's Disease

C

Catholic University (KU) of Leuven

Status

Completed

Conditions

Freezing of Gait
Parkinson Disease

Treatments

Behavioral: SBT
Behavioral: TBT

Study type

Interventional

Funder types

Other

Identifiers

NCT04176263
None was given (Other Grant/Funding Number)
S62825 (KUL) D454/13 (CAU);

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

SBT
Experimental group
Description:
The SBT group will receive a 4-week split-belt treadmill training program consisting of 3 training sessions every week. The training will have a progression of training duration over the four weeks. Participants will start at a total training duration of 30 minutes and this will be increased with 5 minutes every week. The maximal length will be 45 minutes of training. One session including breaks will take approximately 1 hour.
Treatment:
Behavioral: SBT
TBT
Active Comparator group
Description:
The TBT group will receive a 4-week tied-belt treadmill training program consisting of 3 training sessions every week. The training will have a progression of training duration over the four weeks. Participants will start at a total training duration of 30 minutes and this will be increased with 5 minutes every week. The maximal length will be 45 minutes of training. One session including breaks will take approximately 1 hour.
Treatment:
Behavioral: TBT

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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