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Completed

NCT Number: NCT04644367

Effects of a Biomechanical-based Tai Chi Program on Gait and Posture in People With Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Movement Biomechanics Laboratory

Ottawa, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tai Chi intervention

Other

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.

Regular Physical Activity (control) group

Other

Regular Physical Activity group who will not be receiving the TC intervention

Primary outcomes

  1. Change in Center of Mass-Center of Pressure (COM-COP) Separation Distance

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  2. Change in Clearance Distance Height

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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 outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: baseline

    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.

  2. Change in Balance, Lower-limb Muscle Strength

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  3. Change in Mobility

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  4. Change in Mental Flexibility

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  5. Change in Processing Speed

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  6. Change in Mental Switching

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  7. Change in Walking Speed

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  8. Change in Walking Cadence

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

  9. Change in Walking Step Length

    Time frame: baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

    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).

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

The Effects of a Biomechanical Based Tai Chi Intervention Program on Postural Stability and Gait in People With Parkinson's Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 25, 2020
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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