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Parkinson DiseaseNCT04644367

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

A study testing Tai Chi intervention in people with Parkinson Disease, run by University of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
Tai Chi intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
31 Oct 2021to 15 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Human Movement Biomechanics Laboratory

    Ottawa

Other trials in Canada

About this study

Official title: The Effects of a Biomechanical Based Tai Chi Intervention Program on Postural Stability and Gait 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.

Read the 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).

Being tested
Tai Chi intervention, Regular Physical Activity (control) group
Keywords
Parkinson's disease, Gait, postural stability, falls, Tai Chi
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai Chi interventionOther

    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) groupOther

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

Study groups in NCT04644367
Study groupRoleWhat they receive
Tai Chi groupExperimentalThe 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.
Receives: Other: Tai Chi intervention
Regular Physical Activity (control) groupActive comparatorThe 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.
Receives: Other: Regular Physical Activity (control) group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

Secondary outcomes (9)

  1. 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.

    Measured: baseline

  2. 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).

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

  3. 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).

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

  4. 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).

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

  5. 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).

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

  6. 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).

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

  7. 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).

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

  8. 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).

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

  9. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start31 Oct 2021
  3. Primary completion15 May 2022
  4. Study completion15 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, single-blind, randomized control trial of 40 individuals with early-stage PD (Hoehn \& Yahr stages 1 to 3).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04644367
Sponsor's protocol ID
H-01-19-2284
Status last verified
Oct 2022
First submitted
19 Nov 2020
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PubMed 38588457

  • Law NY, Li JX, Zhu Q, Nantel J. Effects of a biomechanical-based Tai Chi program on gait and posture in people with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2023 Jun 30;24(1):241. doi: 10.1186/s13063-023-07146-x.

    PubMed 37386473

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi intervention in people with Parkinson Disease, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04644367, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

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