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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04176263
Enrollment
52
Registered
2019-11-25
Start date
2019-08-12
Completion date
2021-05-11
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Freezing of Gait, Parkinson Disease

Keywords

Parkinson Disease, Freezing of Gait, Rehabilitation, Gait adaptation, Split-belt, Treadmill training

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.

Interventions

BEHAVIORALSBT

The SBT group will receive a 4-week split-belt treadmill training, 3 times a week using a standardized progression protocol. The sessions, including breaks, will approximately take 1 hour each. The training will be given by a trainer experienced with PD.

BEHAVIORALTBT

The TBT group will receive a 4-week tied-belt treadmill training, 3 times a week. To make sure exposure of the two interventions is similar the sessions of the TBT group will be of similar length and progression level (approximately 1 hour each). The training will be given by a trainer experienced with PD.

Sponsors

University of Kiel
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The assessors will be single blinded. Participants will be semi-blinded. The participants will be told that they can be assigned to one of the two forms of treadmill training.They do not know the exact content of the training they would receive and what training is given in the other arm.

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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average overground 360 degree turning speed (degrees/s)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

MeasureTime frameDescription
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)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. In addition to this task the participants also have to perform an auditory stroop task. The participant hears the words 'low' and 'high' in either a low or high pitch in random order and timing. The participant has to respond as quickly as possible to the pitch of the word and not to the word itself.
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).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.
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).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. In addition to this task the participants also have to perform an auditory stroop task. The participant hears the words 'low' and 'high' in either a low or high pitch in random order and timing. The participant has to respond as quickly as possible to the pitch of the word and not to the word itself.

Countries

Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026