Back to resultsEffects of a Biomechanical-based Tai Chi Program on Gait and Posture in People With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tai Chi intervention
Regular Physical Activity (control) group
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Gait, postural stability, falls, Tai Chi
Eligibility Criteria
Inclusion Criteria:
- Have been diagnosed with PD and demonstrate a disease severity ranging from 1 to 3 on the Hoehn and Yahr (H&Y) scale
- Have no fluctuations in motor symptoms as reported by the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)
- Have stable PD (such as levodopa or carbidopa) and doctor-prescribed medication use, that is, fluctuation did not occur at the time of medication intake;
- Can stand and walk independently
- Availability: three times per week over a period of 12 weeks
- Be able to engage in PA for at least 60 min on their own, thrice per week, without prior experience practicing TC regularly.
Exclusion Criteria:
- Enrolled into any other behavioral or pharmacological studies
- Have a Montreal Cognitive Assessment (MoCA) score of < 26/27 (that indicate some mild cognitive impairment (MCI))
- Have had a serious medical condition or uncontrolled hypertension (equal or greater than a systolic 180 or diastolic 110 reading)
- Have any debilitating conditions that could prevent them from performing any PA for a minimum of 60 minutes.
- Have practiced or have experience of practicing TC in an organized class or program within the last 5 years at the start of participation in the study.
Sites / Locations
- Human Movement Biomechanics Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tai Chi group
Regular Physical Activity (control) group
Arm Description
The Tai Chi (TC) group will receive or be taught TC in a class size consisting of about 5-12 students. Classes will be taught by a TC master with more than 4 years of experience practicing either Yang or Wu style TC. The participants will be allowed to practice TC at home and during their leisure time so long as they keep an activity log of their daily TC practice. This monitoring form (i.e. activity log or journal) will be distributed to all members of this group and collected weekly.
The regular physical activity (control) group will be asked to maintain or engage in at least 60 minutes of regular physical activity on their own for three times per week. The participants will be instructed as to the type of regular PA that they may engage in. These types of PA include: walking, cleaning or performing chores inside the home, and/or climbing the stairs. No restriction will be made to limit others forms of physical activity; individuals in the control group will be permitted to engage in organized sports, instructor-led class such as boxing, dance, etc. to ensure the participant recruitment process is feasible. Similar to the TC group, participants in this group will be asked to complete an activity log (or journal) that will be collected weekly to monitor their regular PA levels.
Outcomes
Primary Outcome Measures
Change in Center of Mass-Center of Pressure (COM-COP) Separation Distance
The COM-COP separation distance will be determined from the 3D-motion capture data. The participants will be asked to walk at a self-selected/comfortable pace and to crossover a 20-centimeter-high obstacle placed in the middle of the walkway (5 trials; averaged reported in meters).
Change in Clearance Distance Height
The clearance distance of the toe and heel will be determined from the 3D-motion capture data. The participants will be asked to walk at a self-selected/comfortable pace and to crossover a 20-centimeter-high obstacle placed in the middle of the walkway (5 trials; averaged reported in centimeters). This distance will be determined by the marker position of the heel/toe away from the top of the obstacle.
Secondary Outcome Measures
Montreal Cognitive Assessment (MoCA)
The participants will be administered a set of instructions and be asked to perform a series of cognitive and motor tasks. The total time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points.
Change in Balance, Lower-limb Muscle Strength
Balance and lower-limb muscle strength will be assessed using the Single-leg Stance Test with Eyes Open (SLO) and Closed (SLC). The participant will be asked to stand for as long as possible up to 60 seconds, with either eyes open or closed. Trials will be terminated if the participant loses his or her balance, or if his or her feet are moved from the initial position (randomized order; 3 trials; averaged time of trials reported in second).
Change in Mobility
Mobility will be assessed using the Timed Up and Go (TUG) test. The participants will be instructed to stand up from a chair, walk 3 meters as quick and safely as possible, cross a line marked on floor, turn around, walk back, and sit down (3 trials; time of each trial recorded in seconds).
Change in Mental Flexibility
Mental flexibility will be assessed using the Wisconsin Card Sorting Test (WCST). The participants will be given a deck of 64-cards and will be asked to sort the cards by shape, color, or number. The number of errors made, and number of successful sorted categories (maximum of 6) will be recorded (3 trials; number of errors made recorded).
Change in Processing Speed
Processing speed will be assessed using the Trail Making Test Part B (TMT-B). The participants will be given a set of numbers and letters that they will be asked to connect with lines the numbers to letters in ascending order. The time that it takes the participant to complete this task will be recorded (3 trials; completion time of each trial recorded in seconds).
Change in Mental Switching
Mental switching will be assessed with the Stroop Test. The participants will be asked to name the color but not to read the word on a card. A color-word score will be given based on the total correct identification of the correct color within 45 seconds (3 trials; the total score scored out of 40).
Change in Walking Speed
Walking speed will be determined from the 3D-motion capture data collected along an 8-meter-long walkway. The participants will be asked to walk along the walkway at self-selected/comfortable pace (5 trials; averaged reported in m/s).
Change in Walking Cadence
Walking cadence will be determined from the 3D-motion capture data collected along an 8-meter-long walkway. The participants will be asked to walk along the walkway at self-selected/comfortable pace (5 trials; averaged reported in steps or cycles/min).
Change in Walking Step Length
Step length will be determined from the 3D-motion capture data collected along an 8-meter-long walkway. The participants will be asked to walk along the walkway at self-selected/comfortable pace (5 trials; averaged reported in meters).
Full Information
NCT ID
NCT04644367
First Posted
November 19, 2020
Last Updated
October 1, 2022
Sponsor
University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT04644367
Brief Title
Effects of a Biomechanical-based Tai Chi Program on Gait and Posture in People With Parkinson's Disease
Official Title
The Effects of a Biomechanical Based Tai Chi Intervention Program on Postural Stability and Gait in People With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Parkinson's disease (PD) is associated with changes in gait and posture that can lead to a higher frequency of falls and injuries in this population. Research has shown a positive effect of tai chi (TC) training on the movement capacity for those with PD, however the understanding of the impact of TC training on gait and postural stability in PD is lacking. This study aims to examine the impact of a biomechanical-based TC intervention on dynamic postural stability and how it relates to walking performance. It is hypothesized that the effects of the TC intervention will help to improve measures relating to postural stability, gait, and cognition.
Detailed Description
A prospective, single-blind, randomized control trial of 40 individuals with early-stage PD (Hoehn & Yahr stages 1 to 3). Those with PD will be randomly assigned to either a TC group or a control group. The TC group will participate in a biomechanical-based TC training program that is formed based on the movement analysis of TC and will be practiced two to three times a week for 12 weeks. The control group will be asked to engage or maintain their regular physical activity for a period of 12 weeks. The primary and secondary outcomes will be assessed at baseline, 6-week, and 12-week after commencing the study protocol. The primary outcome measures will include gait speed, cadence, step length during level surface walking (simple task) and fixed-obstacle crossing (challenging task); the dynamic postural stability will be indicated by the center of mass and center of pressure (COM-COP) separation distance and clearance distance measured during fixed-obstacle crossing. The secondary measures will be the Unified Parkinson's disease Rating scale (UPDRS-III), single leg-stance test with eyes open and closed, and three cognitive scores (Stroop Test, Trail Making Test- Part B, and the Wisconsin Card Sorting Test).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Gait, postural stability, falls, Tai Chi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, single-blind, randomized control trial of 40 individuals with early-stage PD (Hoehn & Yahr stages 1 to 3).
Masking
Outcomes Assessor
Masking Description
The principle investigator, co-investigators will analyze and interpret the data, but will be blinded to the group allocation (single-blind). The principle investigator, co-investigators will restrict discussion of the study's outcomes with the research assistants who will be aware allocation, and who will be involved in data entry or collection.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi group
Arm Type
Experimental
Arm Description
The Tai Chi (TC) group will receive or be taught TC in a class size consisting of about 5-12 students. Classes will be taught by a TC master with more than 4 years of experience practicing either Yang or Wu style TC. The participants will be allowed to practice TC at home and during their leisure time so long as they keep an activity log of their daily TC practice. This monitoring form (i.e. activity log or journal) will be distributed to all members of this group and collected weekly.
Arm Title
Regular Physical Activity (control) group
Arm Type
Active Comparator
Arm Description
The regular physical activity (control) group will be asked to maintain or engage in at least 60 minutes of regular physical activity on their own for three times per week. The participants will be instructed as to the type of regular PA that they may engage in. These types of PA include: walking, cleaning or performing chores inside the home, and/or climbing the stairs. No restriction will be made to limit others forms of physical activity; individuals in the control group will be permitted to engage in organized sports, instructor-led class such as boxing, dance, etc. to ensure the participant recruitment process is feasible. Similar to the TC group, participants in this group will be asked to complete an activity log (or journal) that will be collected weekly to monitor their regular PA levels.
Intervention Type
Other
Intervention Name(s)
Tai Chi intervention
Intervention Description
TC classes will be 60 minutes long, offered three times per week over a 12-week period. The participants who receive the TC intervention will be encouraged to attend at minimum two of the three sessions offered per week. The TC classes will follow the same order that will begin with a 5 to 10 minutes warm up, 40 minutes of core activities, and 5 minutes of cool-down. The training intensity and difficulty level of the TC program will gradually proceed from low, moderate, to advance. The classes will be offered in a group setting at a convenient location within a community centre or gymnasium. Alternatively, classes will be offered outdoors in the park or by the canal during the spring-summer months. Due to the COVID-19 situation, additional adaptive measures will be taken using online social platforms such as ZOOM or Hangout to deliver the classes.
Intervention Type
Other
Intervention Name(s)
Regular Physical Activity (control) group
Intervention Description
Regular Physical Activity group who will not be receiving the TC intervention
Primary Outcome Measure Information:
Title
Change in Center of Mass-Center of Pressure (COM-COP) Separation Distance
Description
The COM-COP separation distance will be determined from the 3D-motion capture data. The participants will be asked to walk at a self-selected/comfortable pace and to crossover a 20-centimeter-high obstacle placed in the middle of the walkway (5 trials; averaged reported in meters).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Clearance Distance Height
Description
The clearance distance of the toe and heel will be determined from the 3D-motion capture data. The participants will be asked to walk at a self-selected/comfortable pace and to crossover a 20-centimeter-high obstacle placed in the middle of the walkway (5 trials; averaged reported in centimeters). This distance will be determined by the marker position of the heel/toe away from the top of the obstacle.
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
The participants will be administered a set of instructions and be asked to perform a series of cognitive and motor tasks. The total time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points.
Time Frame
baseline
Title
Change in Balance, Lower-limb Muscle Strength
Description
Balance and lower-limb muscle strength will be assessed using the Single-leg Stance Test with Eyes Open (SLO) and Closed (SLC). The participant will be asked to stand for as long as possible up to 60 seconds, with either eyes open or closed. Trials will be terminated if the participant loses his or her balance, or if his or her feet are moved from the initial position (randomized order; 3 trials; averaged time of trials reported in second).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Mobility
Description
Mobility will be assessed using the Timed Up and Go (TUG) test. The participants will be instructed to stand up from a chair, walk 3 meters as quick and safely as possible, cross a line marked on floor, turn around, walk back, and sit down (3 trials; time of each trial recorded in seconds).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Mental Flexibility
Description
Mental flexibility will be assessed using the Wisconsin Card Sorting Test (WCST). The participants will be given a deck of 64-cards and will be asked to sort the cards by shape, color, or number. The number of errors made, and number of successful sorted categories (maximum of 6) will be recorded (3 trials; number of errors made recorded).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Processing Speed
Description
Processing speed will be assessed using the Trail Making Test Part B (TMT-B). The participants will be given a set of numbers and letters that they will be asked to connect with lines the numbers to letters in ascending order. The time that it takes the participant to complete this task will be recorded (3 trials; completion time of each trial recorded in seconds).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Mental Switching
Description
Mental switching will be assessed with the Stroop Test. The participants will be asked to name the color but not to read the word on a card. A color-word score will be given based on the total correct identification of the correct color within 45 seconds (3 trials; the total score scored out of 40).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Walking Speed
Description
Walking speed will be determined from the 3D-motion capture data collected along an 8-meter-long walkway. The participants will be asked to walk along the walkway at self-selected/comfortable pace (5 trials; averaged reported in m/s).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Walking Cadence
Description
Walking cadence will be determined from the 3D-motion capture data collected along an 8-meter-long walkway. The participants will be asked to walk along the walkway at self-selected/comfortable pace (5 trials; averaged reported in steps or cycles/min).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
Title
Change in Walking Step Length
Description
Step length will be determined from the 3D-motion capture data collected along an 8-meter-long walkway. The participants will be asked to walk along the walkway at self-selected/comfortable pace (5 trials; averaged reported in meters).
Time Frame
baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have been diagnosed with PD and demonstrate a disease severity ranging from 1 to 3 on the Hoehn and Yahr (H&Y) scale
Have no fluctuations in motor symptoms as reported by the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)
Have stable PD (such as levodopa or carbidopa) and doctor-prescribed medication use, that is, fluctuation did not occur at the time of medication intake;
Can stand and walk independently
Availability: three times per week over a period of 12 weeks
Be able to engage in PA for at least 60 min on their own, thrice per week, without prior experience practicing TC regularly.
Exclusion Criteria:
Enrolled into any other behavioral or pharmacological studies
Have a Montreal Cognitive Assessment (MoCA) score of < 26/27 (that indicate some mild cognitive impairment (MCI))
Have had a serious medical condition or uncontrolled hypertension (equal or greater than a systolic 180 or diastolic 110 reading)
Have any debilitating conditions that could prevent them from performing any PA for a minimum of 60 minutes.
Have practiced or have experience of practicing TC in an organized class or program within the last 5 years at the start of participation in the study.
Facility Information:
Facility Name
Human Movement Biomechanics Laboratory
City
Ottawa
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Biomechanical-based Tai Chi Program on Gait and Posture in People With Parkinson's Disease
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