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

Primary Purpose

Parkinson Disease, Freezing of Gait

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SBT
TBT
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Freezing of Gait, Rehabilitation, Gait adaptation, Split-belt, Treadmill training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • KU Leuven
  • University Hospital Schleswig-Holstein (UKSH), Christian-Albrechts-University Kiel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SBT

TBT

Arm 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.

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.

Outcomes

Primary Outcome Measures

Average overground 360 degree turning speed (degrees/s)
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 Outcome Measures

Average dual task overground 360 degree turning speed (degrees/sec)
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)
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)
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.

Full Information

First Posted
November 16, 2019
Last Updated
August 9, 2021
Sponsor
KU Leuven
Collaborators
University of Kiel
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1. Study Identification

Unique Protocol Identification Number
NCT04176263
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
University of Kiel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Freezing of Gait
Keywords
Parkinson Disease, Freezing of Gait, Rehabilitation, Gait adaptation, Split-belt, Treadmill training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBT
Arm Type
Experimental
Arm 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.
Arm Title
TBT
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
SBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average overground 360 degree turning speed (degrees/s)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Average dual task overground 360 degree turning speed (degrees/sec)
Description
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.
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)
Title
Retention of average overground 360 degree turning speed (degrees/sec)
Description
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.
Time Frame
Change in performance from post-intervention 1 week after the 4-week training period ended (Retest 1) to retention, 5 weeks later (Retest 2).
Title
Retention of dual task average overground 360 degree turning speed (degrees/sec)
Description
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.
Time Frame
Change in performance from post-intervention 1 week after the 4-week training period ended (Retest 1) to retention, 5 weeks later (Retest 2).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Nieuwboer, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Schlenstedt, PhD
Organizational Affiliation
Christian-Albrechts-University of Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3001
Country
Belgium
Facility Name
University Hospital Schleswig-Holstein (UKSH), Christian-Albrechts-University Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30771729
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.
Results Reference
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The Effect of Split-belt Treadmill Training on Gait in Parkinson's Disease

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