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Effect of Action Observation Training on Gait Variables and Global Cognitive Functions

The Effect of Action Observation Training on Gait Variables and Global Cognitive Functions in Older Adult With Mild Cognitive Impairment: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03522389
Enrollment
39
Registered
2018-05-11
Start date
2018-05-15
Completion date
2019-06-30
Last updated
2025-07-03

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

Conditions

Mild Cognitive Impairment

Keywords

Action Observation Training, Gait

Brief summary

This study will investigate the effect of Action Observation Teaining (AOT) on gait variables and global cognitive functions in older adults with mild cognitive impairment (MCI). The specific objectives are 1) to compare gait variables and global cognitive functions among the AOT with gait training, gait training, and control groups at before training, after training, and follow up and 2) to compare gait variables and global cognitive functions among before training, after training, and follow up in each of the groups.

Detailed description

Participants in this study will be older adults recruiting from the Physical Therapy Center of Mahidol University, Siriraj hospital, and community at Phuttamonthon area (n = 39). They will be diagnosed as a MCI, using core clinical criteria of the National Institute on Aging and the Alzheimer's Association by a physiotherapist. Prior to participate in the study, participants will be informed the details of the study and sign the informed consent. All participants will be recorded the demographic data and will be assessed visual acuity, hearing, sensation and muscle strength of lower extremity, balance, gait variables, and global cognitive function. Participants who pass the criteria will be randomly assigned to either the AOT with gait training group (n = 13), the gait training group (n = 13), and the control group (n = 13) by stratified randomization. Gait variables will be collected by the Force Distribution Measurement platform during walking at comfortable speed (single task) and during counting backwards from 100 by sevens (dual tasks). Global cognitive function will be assessed by the Montral Cognitve Assessment (MoCA). All varaibles will be assessed 3 times which will be at before training, after 4-week of training, and 4-week follow-up.

Interventions

PROCEDUREAOT with gait training

AOT with gait training composes of program of watching video in different views of normal walk for 5 min. After that, participants will receive gait training program. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome.

PROCEDUREGait training

To control a total time of training, the gait training group will watch video of Vincent van Gogh's painting for 5 min. After that, participants will training the gait as protocol of experimental group. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome.

OTHEREducation

There will be no intervention exercise program provide for the control group. They will receive education about dementia such as definition, etiology, sign and symptom, and caring.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Aged 60-80 years old. * Having subjective evidence of cognitive decline from patients, or from closely informants, or from a clinicians. * Having objective evidence of cognitive decline, defined by using a Montreal Cognitive Assessment (MoCA) 18-24 points. * Independent function in daily life * Independent walking without using gait aids. * Having fall risk, defined by the fall risk threshold (gait velocity \< 1 m/s in walking while counting backwards from 100 by sevens). * Able to understand Thai language and follow study protocol.

Exclusion criteria

* Having history of stroke or heart attack or Parkinsonism symptoms. * The presence of major depression disorder defined by a Patient Health Questionnaire-9 \> 9 points. * Diagnosis as dementia by neurologists. * Any cardiac or respiratory disease that could cause gait limiting. * Musculoskeletal disorder that affected gait performance. * Balance disorder in assessment day, such as vertigo and dizziness. * Visual acuity with a glasses worse than 6/15 (metric system) in both their eyes.

Design outcomes

Primary

MeasureTime frameDescription
Gait Speed During the Single TaskBaseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)Gait speed during the single-task condition was measured in meter per second while participants walked at a comfortable pace over a measurement platform without performing any secondary task. Higher gait speed values indicate better physical function and mobility, whereas lower values may reflect impaired motor performance or increased risk of functional decline. Unit of Measure: meters per second (m/s)
Gait Speed During the Dual TaskBaseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)Gait speed during the dual-task condition was measured in meters per second (m/s), while participants walked at a comfortable pace over a measurement platform while simultaneously counting a number backward by 7. Higher gait speed values indicate better cognitive-motor performance, while lower values suggest impaired dual-task ability and potential functional or cognitive decline. Unit of Measure: meters per second (m/s).

Secondary

MeasureTime frameDescription
Stride Time Variability During Single TaskBaseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)Stride time variability during single task was measured while participants walked at a comfortable pace over a measurement platform. Stride time refers to the duration between successive heel contacts of the same foot. The variability of stride time was quantified using the coefficient of variation (CV), calculated as: (standard deviation of stride time / mean stride time) × 100. Higher CV values indicate greater variability in stride timing, which reflects reduced gait stability or impaired coordination. Lower CV values are considered better outcomes, indicating more stable and consistent gait. Unit of Measure: percentage of coefficient of variation (% Cov).
Stride Time Variability During Dual TaskBaseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)Stride time variability during dual-task walking was measured while participants walked at a comfortable pace, together with counting a number backward by 7 over a measurement platform. Stride time refers to the duration between successive heel contacts of the same foot. The variability of stride time was quantified using the coefficient of variation (CV), calculated as: (standard deviation of stride time / mean stride time) × 100. Higher CV values indicate greater variability in stride timing, which reflects reduced gait stability or impaired motor-cognitive coordination. Lower CV values are considered better outcomes, indicating more stable and consistent gait. Unit of Measure: percentage of coefficient of variation (% Cov).
Montreal Cognitive Assessment (MoCA)Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)The Montreal Cognitive Assessment (MoCA) is a global cognitive screening tool designed to assess multiple cognitive domains, including attention, memory, language, visuospatial skills, executive function, and orientation. The test consists of 30 points in total and ranges from 0 to 30, with higher scores indicating better cognitive function. Unit of Measure: scores.

Countries

Thailand

Participant flow

Pre-assignment details

Of the 97 participants initially assessed for eligibility, 58 were excluded: 55 did not meet the inclusion criteria and 3 declined to participate. Therefore, 39 participants were enrolled and randomly assigned to one of the three groups.

Participants by arm

ArmCount
AOT With Gait Training Group
Action observation training with gait training AOT with gait training: AOT with gait training composes of program of watching video in different views of normal walk for 5 min. After that, participants will receive gait training program. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome.
11
Gait Training Group
Gait training Gait training: To control a total time of training, the gait training group will watch video of Vincent van Gogh's painting for 5 min. After that, participants will training the gait as protocol of experimental group. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome.
11
Control Group
Education Education: There will be no intervention exercise program provide for the control group. They will receive education about dementia such as definition, etiology, sign and symptom, and caring.
11
Total33

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall Studygo to work in other province100
Overall Studyhad herniated nucleus pulposus010
Overall StudyLost to Follow-up112

Baseline characteristics

CharacteristicAOT With Gait Training GroupGait Training GroupControl GroupTotal
Age, Continuous67.64 years
STANDARD_DEVIATION 4.64
67.50 years
STANDARD_DEVIATION 5.6
65.71 years
STANDARD_DEVIATION 2.45
66.92 years
STANDARD_DEVIATION 4.43
Body mass index24.08 kg/m^2
STANDARD_DEVIATION 3.19
24.71 kg/m^2
STANDARD_DEVIATION 3.69
25.38 kg/m^2
STANDARD_DEVIATION 3.8
24.72 kg/m^2
STANDARD_DEVIATION 3.57
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
9 Participants8 Participants8 Participants25 Participants
Sex: Female, Male
Male
2 Participants3 Participants3 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 110 / 11
other
Total, other adverse events
0 / 110 / 110 / 11
serious
Total, serious adverse events
0 / 110 / 110 / 11

Outcome results

Primary

Gait Speed During the Dual Task

Gait speed during the dual-task condition was measured in meters per second (m/s), while participants walked at a comfortable pace over a measurement platform while simultaneously counting a number backward by 7. Higher gait speed values indicate better cognitive-motor performance, while lower values suggest impaired dual-task ability and potential functional or cognitive decline. Unit of Measure: meters per second (m/s).

Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

ArmMeasureGroupValue (MEAN)Dispersion
AOT With Gait Training GroupGait Speed During the Dual TaskAfter 4 weeks of training (T2)0.86 m/sStandard Error 0.22
AOT With Gait Training GroupGait Speed During the Dual TaskBaseline (T1)0.69 m/sStandard Error 0.17
AOT With Gait Training GroupGait Speed During the Dual TaskAfter 4 weeks of training - Baseline (T2-T1)0.17 m/sStandard Error 0.07
AOT With Gait Training GroupGait Speed During the Dual Task1-month follow-up - Baseline (T3-T1)0.15 m/sStandard Error 0.08
AOT With Gait Training GroupGait Speed During the Dual Task1-month follow-up (T3)0.84 m/sStandard Error 0.23
Gait Training GroupGait Speed During the Dual TaskBaseline (T1)0.70 m/sStandard Error 0.24
Gait Training GroupGait Speed During the Dual TaskAfter 4 weeks of training - Baseline (T2-T1)0.12 m/sStandard Error 0.13
Gait Training GroupGait Speed During the Dual Task1-month follow-up - Baseline (T3-T1)0.12 m/sStandard Error 0.13
Gait Training GroupGait Speed During the Dual TaskAfter 4 weeks of training (T2)0.82 m/sStandard Error 0.24
Gait Training GroupGait Speed During the Dual Task1-month follow-up (T3)0.82 m/sStandard Error 0.23
Control GroupGait Speed During the Dual Task1-month follow-up (T3)0.68 m/sStandard Error 0.18
Control GroupGait Speed During the Dual TaskAfter 4 weeks of training (T2)0.62 m/sStandard Error 0.19
Control GroupGait Speed During the Dual TaskAfter 4 weeks of training - Baseline (T2-T1)-0.02 m/sStandard Error 0.07
Control GroupGait Speed During the Dual TaskBaseline (T1)0.64 m/sStandard Error 0.18
Control GroupGait Speed During the Dual Task1-month follow-up - Baseline (T3-T1)0.04 m/sStandard Error 0.1
Comparison: After 4 weeks of training - Baseline (T2-T1)p-value: <0.001ANOVA
Comparison: 1-month follow-up - Baseline (T3-T1)p-value: 0.039ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Comparison: Within group comparisonp-value: 0.002ANOVA
Comparison: Within group comparisonp-value: 0.117ANOVA
Primary

Gait Speed During the Single Task

Gait speed during the single-task condition was measured in meter per second while participants walked at a comfortable pace over a measurement platform without performing any secondary task. Higher gait speed values indicate better physical function and mobility, whereas lower values may reflect impaired motor performance or increased risk of functional decline. Unit of Measure: meters per second (m/s)

Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

ArmMeasureGroupValue (MEAN)Dispersion
AOT With Gait Training GroupGait Speed During the Single Task1-month follow-up (T3)1.01 m/sStandard Deviation 0.15
AOT With Gait Training GroupGait Speed During the Single TaskAfter 4 weeks of training - Baseline (T2-T1)0.17 m/sStandard Deviation 0.1
AOT With Gait Training GroupGait Speed During the Single TaskBaseline (T1)0.86 m/sStandard Deviation 0.16
AOT With Gait Training GroupGait Speed During the Single Task1-month follow-up - Baseline (T3-T1)0.15 m/sStandard Deviation 0.09
AOT With Gait Training GroupGait Speed During the Single TaskAfter 4 weeks of training (T2)1.02 m/sStandard Deviation 0.15
Gait Training GroupGait Speed During the Single Task1-month follow-up - Baseline (T3-T1)0.12 m/sStandard Deviation 0.08
Gait Training GroupGait Speed During the Single Task1-month follow-up (T3)1.06 m/sStandard Deviation 0.1
Gait Training GroupGait Speed During the Single TaskAfter 4 weeks of training (T2)1.03 m/sStandard Deviation 0.1
Gait Training GroupGait Speed During the Single TaskAfter 4 weeks of training - Baseline (T2-T1)0.09 m/sStandard Deviation 0.12
Gait Training GroupGait Speed During the Single TaskBaseline (T1)0.94 m/sStandard Deviation 0.14
Control GroupGait Speed During the Single Task1-month follow-up (T3)0.87 m/sStandard Deviation 0.17
Control GroupGait Speed During the Single TaskAfter 4 weeks of training - Baseline (T2-T1)0.00 m/sStandard Deviation 0.08
Control GroupGait Speed During the Single Task1-month follow-up - Baseline (T3-T1)-0.01 m/sStandard Deviation 0.1
Control GroupGait Speed During the Single TaskAfter 4 weeks of training (T2)0.88 m/sStandard Deviation 0.15
Control GroupGait Speed During the Single TaskBaseline (T1)0.88 m/sStandard Deviation 0.15
Comparison: After 4 weeks of training - Baseline (T2-T1)p-value: 0.003ANOVA
Comparison: 1-month follow up - Baseline (T3-T1)p-value: <0.001ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Comparison: Within group comparisonp-value: 0.006ANOVA
Comparison: Within group comparisonp-value: 0.793ANOVA
Secondary

Montreal Cognitive Assessment (MoCA)

The Montreal Cognitive Assessment (MoCA) is a global cognitive screening tool designed to assess multiple cognitive domains, including attention, memory, language, visuospatial skills, executive function, and orientation. The test consists of 30 points in total and ranges from 0 to 30, with higher scores indicating better cognitive function. Unit of Measure: scores.

Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

ArmMeasureGroupValue (MEAN)Dispersion
AOT With Gait Training GroupMontreal Cognitive Assessment (MoCA)After 4 weeks of training (T2)24.64 scoresStandard Deviation 2.34
AOT With Gait Training GroupMontreal Cognitive Assessment (MoCA)Baseline (T1)22.18 scoresStandard Deviation 1.47
AOT With Gait Training GroupMontreal Cognitive Assessment (MoCA)After 4 weeks of training - Baseline (T2-T1)2.45 scoresStandard Deviation 1.63
AOT With Gait Training GroupMontreal Cognitive Assessment (MoCA)1-month follow-up - Baseline (T3-T1)4.64 scoresStandard Deviation 1.86
AOT With Gait Training GroupMontreal Cognitive Assessment (MoCA)1-month follow-up (T3)26.82 scoresStandard Deviation 2.04
Gait Training GroupMontreal Cognitive Assessment (MoCA)Baseline (T1)22.64 scoresStandard Deviation 1.36
Gait Training GroupMontreal Cognitive Assessment (MoCA)After 4 weeks of training - Baseline (T2-T1)1.36 scoresStandard Deviation 2.69
Gait Training GroupMontreal Cognitive Assessment (MoCA)1-month follow-up - Baseline (T3-T1)2.36 scoresStandard Deviation 2.8
Gait Training GroupMontreal Cognitive Assessment (MoCA)After 4 weeks of training (T2)24.00 scoresStandard Deviation 2.86
Gait Training GroupMontreal Cognitive Assessment (MoCA)1-month follow-up (T3)25.00 scoresStandard Deviation 3.16
Control GroupMontreal Cognitive Assessment (MoCA)1-month follow-up (T3)24.54 scoresStandard Deviation 2.91
Control GroupMontreal Cognitive Assessment (MoCA)After 4 weeks of training (T2)24.45 scoresStandard Deviation 2.91
Control GroupMontreal Cognitive Assessment (MoCA)After 4 weeks of training - Baseline (T2-T1)2.27 scoresStandard Deviation 1.9
Control GroupMontreal Cognitive Assessment (MoCA)Baseline (T1)22.18 scoresStandard Deviation 1.94
Control GroupMontreal Cognitive Assessment (MoCA)1-month follow-up - Baseline (T3-T1)2.36 scoresStandard Deviation 2.29
Comparison: After 4 weeks of training - Baseline (T2-T1)p-value: 0.445ANOVA
Comparison: 1-month follow-up - Baseline (T3-T1)p-value: 0.046ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Comparison: Within group comparisonp-value: 0.028ANOVA
Comparison: Within group comparisonp-value: 0.002ANOVA
Secondary

Stride Time Variability During Dual Task

Stride time variability during dual-task walking was measured while participants walked at a comfortable pace, together with counting a number backward by 7 over a measurement platform. Stride time refers to the duration between successive heel contacts of the same foot. The variability of stride time was quantified using the coefficient of variation (CV), calculated as: (standard deviation of stride time / mean stride time) × 100. Higher CV values indicate greater variability in stride timing, which reflects reduced gait stability or impaired motor-cognitive coordination. Lower CV values are considered better outcomes, indicating more stable and consistent gait. Unit of Measure: percentage of coefficient of variation (% Cov).

Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

ArmMeasureGroupValue (MEAN)Dispersion
AOT With Gait Training GroupStride Time Variability During Dual TaskAfter 4 weeks of training - Baseline (T2-T1)-1.41 % CovStandard Deviation 2.5
AOT With Gait Training GroupStride Time Variability During Dual TaskAfter 4 weeks of training (T2)3.89 % CovStandard Deviation 2.29
AOT With Gait Training GroupStride Time Variability During Dual Task1-month follow-up - Baseline (T3-T1)-1.57 % CovStandard Deviation 2.76
AOT With Gait Training GroupStride Time Variability During Dual TaskBaseline (T1)5.30 % CovStandard Deviation 3.9
AOT With Gait Training GroupStride Time Variability During Dual Task1-month follow-up (T3)3.73 % CovStandard Deviation 2.06
Gait Training GroupStride Time Variability During Dual Task1-month follow-up - Baseline (T3-T1)-1.15 % CovStandard Deviation 1.9
Gait Training GroupStride Time Variability During Dual Task1-month follow-up (T3)4.19 % CovStandard Deviation 4.85
Gait Training GroupStride Time Variability During Dual TaskBaseline (T1)5.34 % CovStandard Deviation 4.93
Gait Training GroupStride Time Variability During Dual TaskAfter 4 weeks of training (T2)4.95 % CovStandard Deviation 5.95
Gait Training GroupStride Time Variability During Dual TaskAfter 4 weeks of training - Baseline (T2-T1)-0.38 % CovStandard Deviation 2.63
Control GroupStride Time Variability During Dual TaskAfter 4 weeks of training - Baseline (T2-T1)0.93 % CovStandard Deviation 3.18
Control GroupStride Time Variability During Dual Task1-month follow-up - Baseline (T3-T1)1.20 % CovStandard Deviation 3.55
Control GroupStride Time Variability During Dual TaskAfter 4 weeks of training (T2)6.34 % CovStandard Deviation 4.4
Control GroupStride Time Variability During Dual Task1-month follow-up (T3)6.61 % CovStandard Deviation 3.74
Control GroupStride Time Variability During Dual TaskBaseline (T1)5.41 % CovStandard Deviation 2.63
Comparison: After 4 weeks of training - Baseline (T2-T1)p-value: 0.161ANOVA
Comparison: 1-month follow-up - Baseline (T3-T1)p-value: 0.161ANOVA
Comparison: Within group comparisonp-value: 0.076ANOVA
Comparison: Within group comparisonp-value: 0.211ANOVA
Comparison: Within group comparisonp-value: 0.573ANOVA
Secondary

Stride Time Variability During Single Task

Stride time variability during single task was measured while participants walked at a comfortable pace over a measurement platform. Stride time refers to the duration between successive heel contacts of the same foot. The variability of stride time was quantified using the coefficient of variation (CV), calculated as: (standard deviation of stride time / mean stride time) × 100. Higher CV values indicate greater variability in stride timing, which reflects reduced gait stability or impaired coordination. Lower CV values are considered better outcomes, indicating more stable and consistent gait. Unit of Measure: percentage of coefficient of variation (% Cov).

Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

ArmMeasureGroupValue (MEAN)Dispersion
AOT With Gait Training GroupStride Time Variability During Single TaskAfter 4 weeks of training (T2)2.48 %CovStandard Deviation 0.73
AOT With Gait Training GroupStride Time Variability During Single TaskBaseline (T1)2.42 %CovStandard Deviation 1.15
AOT With Gait Training GroupStride Time Variability During Single TaskAfter 4 weeks of training - Baseline (T2-T1)0.06 %CovStandard Deviation 1.49
AOT With Gait Training GroupStride Time Variability During Single Task1-month follow-up - Baseline (T3-T1)-0.09 %CovStandard Deviation 1.73
AOT With Gait Training GroupStride Time Variability During Single Task1-month follow-up (T3)2.33 %CovStandard Deviation 0.89
Gait Training GroupStride Time Variability During Single TaskBaseline (T1)1.85 %CovStandard Deviation 0.78
Gait Training GroupStride Time Variability During Single TaskAfter 4 weeks of training - Baseline (T2-T1)0.01 %CovStandard Deviation 0.89
Gait Training GroupStride Time Variability During Single Task1-month follow-up - Baseline (T3-T1)-0.05 %CovStandard Deviation 1.19
Gait Training GroupStride Time Variability During Single TaskAfter 4 weeks of training (T2)1.86 %CovStandard Deviation 0.71
Gait Training GroupStride Time Variability During Single Task1-month follow-up (T3)1.80 %CovStandard Deviation 0.72
Control GroupStride Time Variability During Single Task1-month follow-up (T3)2.33 %CovStandard Deviation 1.12
Control GroupStride Time Variability During Single TaskAfter 4 weeks of training (T2)2.87 %CovStandard Deviation 1.21
Control GroupStride Time Variability During Single TaskAfter 4 weeks of training - Baseline (T2-T1)0.20 %CovStandard Deviation 0.95
Control GroupStride Time Variability During Single TaskBaseline (T1)2.67 %CovStandard Deviation 0.98
Control GroupStride Time Variability During Single Task1-month follow-up - Baseline (T3-T1)-0.34 %CovStandard Deviation 0.69
Comparison: After 4 weeks of training - Baseline (T2-T1)p-value: 0.924ANOVA
Comparison: 1-month follow-up - Baseline (T3-T1)p-value: 0.855ANOVA
Comparison: Within group comparisonp-value: 0.937ANOVA
Comparison: Within group comparisonp-value: 0.97ANOVA
Comparison: Within group comparisonp-value: 0.242ANOVA

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