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A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II

A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05006261
Enrollment
30
Registered
2021-08-16
Start date
2021-09-29
Completion date
2023-10-18
Last updated
2024-12-10

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

Conditions

Healthy Aging

Brief summary

This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.

Detailed description

The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, and gait, and evaluate changes in TC proficiency. Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks). Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.

Interventions

12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.

Sponsors

Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women between 60 and 85 years old * TC naïve (i.e., never practiced TC) * Self-reported ability to walk continuously for 15 minutes without an assistive device * Working email address * Prior experience with and current access to a computer, smart phone or tablet device

Exclusion criteria

* Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke) * Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with the ability of prospective volunteers to safely participate in the study * Active cancer * Significant musculoskeletal conditions requiring chronic use of pain medication * Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score \< 18)

Design outcomes

Primary

MeasureTime frameDescription
Protocol AdherencePost-intervention (approximately 12 weeks)The percentage of Tai Chi home practice sessions completed by participants.
RetentionThrough study completion, approximately 12 weeks from the beginning of the studyThe percentage of participants who complete the study.
System Usability ScalePost-intervention (approximately 12 weeks)The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.

Other

MeasureTime frameDescription
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresBaseline and post-intervention (approximately 12 weeks)The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome.
Changes From Baseline in Physical Activity Scale for the Elderly (PASE)Baseline and post-intervention (approximately 12 weeks)Physical Activity Scale for the Elderly (PASE): self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities for 4.5 hours per day.
Changes From Baseline in Trail Making Test A/B ScoresBaseline and post-intervention (approximately 12 weeks)Trail Making Test (TMT): Test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test.
Changes From Baseline in Self-Efficacy Exercise (SEE) QuestionnaireBaseline and post-intervention (approximately 12 weeks)Exercise Self-efficacy Questionnaire (SEE): 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.
Changes From Baseline in Tai Chi Proficiency ScoresChange from Baseline at Post-Intervention (approximately 12 weeks)Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency.
Changes From Baseline in Timed-Up-and-GoBaseline and post-intervention (approximately 12 weeks)Timed-Up-and-Go: Test to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair.
Changes From Baseline in Timed-Up-and-Go Dual TaskBaseline and post-intervention (approximately 12 weeks)Dual task Timed-Up-and-Go test: The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three.
Changes From Baseline in Single Leg StanceBaseline and post-intervention (approximately 12 weeks)Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds.
Postural Sway and Balance on Both Legs With Feet Shoulder-width ApartBaseline and post-intervention (approximately 12 weeks)Balance on both legs with feet shoulder-width apart: The participant is asked to stand with feet shoulder-width apart for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 4 variables.
Postural Sway and Balance on Both Legs With Feet Close to Each OtherBaseline and post-intervention (approximately 12 weeks)Balance on both legs with feet close to each other: The participant is asked to stand with feet as close as possible (without contact between the feet) for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for a total of 4 variables.
Normalized-to-height Stride LengthBaseline and post-intervention (approximately 12 weeks)Study participants will undergo an instrumented gait evaluation. Stride length will be defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length will be derived by computing the stride length using the gait evaluation equipment and dividing such value by the height of the study participant.
Stride Time VariabilityBaseline and post-intervention (approximately 12 weeks)Study participants will undergo an instrumented gait evaluation. Stride time will be defined as the time interval between two consecutive foot contacts of the same limb. Stride time variability will be computed as the standard deviation of the stride time estimates derived using the gait evaluation equipment.
Changes From Baseline in Activity LevelBaseline and end of intervention (approximately 12 weeks)Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor.
Changes From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)Baseline and end of intervention (approximately 12 weeks)MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.
Changes From Baseline in Sit-to-Stand PerformanceBaseline and post-intervention (approximately 12 weeks)Sit-to-Stand Test: The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. A higher count of completed repetitions is considered indicative of improved performance.
Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)Post-intervention (approximately 12 weeks)Qualitative interview about ease of use of the Tele-Tai Chi platform. The outcome will be the percentage of participants who provide positive feedback regarding the platform's ease of use.
Changes From Baseline in Activities-specific Balance Confidence (ABC) ScoresBaseline and post-intervention (approximately 12 weeks)Activities-specific Balance Confidence (ABC): 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Tele-Tai Chi
Tele-Tai Chi intervention Tele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.
27
Total27

Baseline characteristics

CharacteristicTele-Tai Chi
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
21 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous70 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
27 Participants
Region of Enrollment
United States
27 participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 26
other
Total, other adverse events
14 / 26
serious
Total, serious adverse events
0 / 26

Outcome results

Primary

Protocol Adherence

The percentage of Tai Chi home practice sessions completed by participants.

Time frame: Post-intervention (approximately 12 weeks)

Population: All dataset was considered

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiProtocol Adherence76.81 percentage of session completedStandard Deviation 37.32
Primary

Retention

The percentage of participants who complete the study.

Time frame: Through study completion, approximately 12 weeks from the beginning of the study

ArmMeasureValue (NUMBER)
Tele-Tai ChiRetention100 percentage of subject retained
Primary

System Usability Scale

The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.

Time frame: Post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiSystem Usability Scale87.18 score on a scaleStandard Deviation 13.31
Other Pre-specified

Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores

Activities-specific Balance Confidence (ABC): 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete and extreme outliers were eliminated. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Activities-specific Balance Confidence (ABC) Scores1.48 score on a scaleStandard Deviation 33.59
Other Pre-specified

Changes From Baseline in Activity Level

Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor.

Time frame: Baseline and end of intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Activity Level1044 steps per dayStandard Deviation 2526
Other Pre-specified

Changes From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)

MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Time frame: Baseline and end of intervention (approximately 12 weeks)

Population: Data analysis was limited only to subjects who completed both baseline and post-intervention assessments in the laboratory.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)0.5 score on a scaleStandard Deviation 1.5
Other Pre-specified

Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores

The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresAbility to Participate in Social Roles/Activities-0.31 score on a scaleStandard Deviation 2.31
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresAnxiety/Fear0.10 score on a scaleStandard Deviation 1.68
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresDepression and Sadness0.26 score on a scaleStandard Deviation 1.33
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresFatigue-0.78 score on a scaleStandard Deviation 2.19
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresPain Interference-0.42 score on a scaleStandard Deviation 1.49
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresPhysical Function0.21 score on a scaleStandard Deviation 0.76
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresSleep Disturbance-0.57 score on a scaleStandard Deviation 2.08
Tele-Tai ChiChanges From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 ScoresPain Intensity-0.26 score on a scaleStandard Deviation 1.11
Other Pre-specified

Changes From Baseline in Physical Activity Scale for the Elderly (PASE)

Physical Activity Scale for the Elderly (PASE): self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities for 4.5 hours per day.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Physical Activity Scale for the Elderly (PASE)27.73 score on a scaleStandard Deviation 71.16
Other Pre-specified

Changes From Baseline in Self-Efficacy Exercise (SEE) Questionnaire

Exercise Self-efficacy Questionnaire (SEE): 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Self-Efficacy Exercise (SEE) Questionnaire-12.6 score on a scaleStandard Deviation 19.92
Other Pre-specified

Changes From Baseline in Single Leg Stance

Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Single Leg StanceLeft Leg1.75 secondsStandard Deviation 7.67
Tele-Tai ChiChanges From Baseline in Single Leg StanceRight Leg0.73 secondsStandard Deviation 10.04
Other Pre-specified

Changes From Baseline in Sit-to-Stand Performance

Sit-to-Stand Test: The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. A higher count of completed repetitions is considered indicative of improved performance.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset is incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Sit-to-Stand Performance0.04 score on a scaleStandard Deviation 1.56
Other Pre-specified

Changes From Baseline in Tai Chi Proficiency Scores

Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency.

Time frame: Change from Baseline at Post-Intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Tai Chi Proficiency Scores6.42 score on a scaleStandard Deviation 2.86
Other Pre-specified

Changes From Baseline in Timed-Up-and-Go

Timed-Up-and-Go: Test to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Timed-Up-and-Go0.00 secondsStandard Deviation 1.2
Other Pre-specified

Changes From Baseline in Timed-Up-and-Go Dual Task

Dual task Timed-Up-and-Go test: The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Timed-Up-and-Go Dual Task0.08 secondsStandard Deviation 1.78
Other Pre-specified

Changes From Baseline in Trail Making Test A/B Scores

Trail Making Test (TMT): Test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis. For the analysis of Part A only 24 patients were considered.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiChanges From Baseline in Trail Making Test A/B ScoresPart A-0.24 secondsStandard Deviation 7.81
Tele-Tai ChiChanges From Baseline in Trail Making Test A/B ScoresPart B-3.37 secondsStandard Deviation 35.06
Other Pre-specified

Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)

Qualitative interview about ease of use of the Tele-Tai Chi platform. The outcome will be the percentage of participants who provide positive feedback regarding the platform's ease of use.

Time frame: Post-intervention (approximately 12 weeks)

Population: All dataset analyzed.

ArmMeasureValue (NUMBER)
Tele-Tai ChiEase of Use of the Tele-Tai Chi Platform (Qualitative Interview)85 percentage of participants
Other Pre-specified

Normalized-to-height Stride Length

Study participants will undergo an instrumented gait evaluation. Stride length will be defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length will be derived by computing the stride length using the gait evaluation equipment and dividing such value by the height of the study participant.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset is incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiNormalized-to-height Stride LengthNormalized Stride Length - Baseline (unitless)0.41 unitlessStandard Deviation 0.04
Tele-Tai ChiNormalized-to-height Stride LengthNormalized Stride Length - Post Intervention (unitless)0.41 unitlessStandard Deviation 0.06
Other Pre-specified

Postural Sway and Balance on Both Legs With Feet Close to Each Other

Balance on both legs with feet close to each other: The participant is asked to stand with feet as close as possible (without contact between the feet) for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for a total of 4 variables.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: Data analysis was limited only to subjects who completed in the intervention and completed both baseline and post-intervention assessments. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Close to Each OtherAP - Baseline60.14 millimeters per second squaredStandard Deviation 1.35
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Close to Each OtherAP - Post Intervention60.57 millimeters per second squaredStandard Deviation 0.57
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Close to Each OtherML - Baseline59.93 millimeters per second squaredStandard Deviation 1.18
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Close to Each OtherML - Post Intervention60.35 millimeters per second squaredStandard Deviation 0.65
Other Pre-specified

Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart

Balance on both legs with feet shoulder-width apart: The participant is asked to stand with feet shoulder-width apart for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 4 variables.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Shoulder-width ApartAP-Baseline60.03 millimeters per second squaredStandard Deviation 1.3
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Shoulder-width ApartAP-Post Intervention60.73 millimeters per second squaredStandard Deviation 0.82
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Shoulder-width ApartML-Baseline60.05 millimeters per second squaredStandard Deviation 1.36
Tele-Tai ChiPostural Sway and Balance on Both Legs With Feet Shoulder-width ApartML-Post Intervention60.48 millimeters per second squaredStandard Deviation 0.92
Other Pre-specified

Stride Time Variability

Study participants will undergo an instrumented gait evaluation. Stride time will be defined as the time interval between two consecutive foot contacts of the same limb. Stride time variability will be computed as the standard deviation of the stride time estimates derived using the gait evaluation equipment.

Time frame: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Tele-Tai ChiStride Time VariabilityStride Time Variability - Baseline10.32 millisecondsStandard Deviation 8.79
Tele-Tai ChiStride Time VariabilityStride Time Variability - Discharge12.27 millisecondsStandard Deviation 14.7

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