Mild Cognitive Impairment
Conditions
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
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.
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed During the Single Task | Baseline (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 Task | Baseline (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
| Measure | Time frame | Description |
|---|---|---|
| Stride Time Variability During Single Task | Baseline (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 Task | Baseline (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
| Arm | Count |
|---|---|
| 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 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | go to work in other province | 1 | 0 | 0 |
| Overall Study | had herniated nucleus pulposus | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | AOT With Gait Training Group | Gait Training Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 67.64 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 index | 24.08 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 Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 8 Participants | 25 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AOT With Gait Training Group | Gait Speed During the Dual Task | After 4 weeks of training (T2) | 0.86 m/s | Standard Error 0.22 |
| AOT With Gait Training Group | Gait Speed During the Dual Task | Baseline (T1) | 0.69 m/s | Standard Error 0.17 |
| AOT With Gait Training Group | Gait Speed During the Dual Task | After 4 weeks of training - Baseline (T2-T1) | 0.17 m/s | Standard Error 0.07 |
| AOT With Gait Training Group | Gait Speed During the Dual Task | 1-month follow-up - Baseline (T3-T1) | 0.15 m/s | Standard Error 0.08 |
| AOT With Gait Training Group | Gait Speed During the Dual Task | 1-month follow-up (T3) | 0.84 m/s | Standard Error 0.23 |
| Gait Training Group | Gait Speed During the Dual Task | Baseline (T1) | 0.70 m/s | Standard Error 0.24 |
| Gait Training Group | Gait Speed During the Dual Task | After 4 weeks of training - Baseline (T2-T1) | 0.12 m/s | Standard Error 0.13 |
| Gait Training Group | Gait Speed During the Dual Task | 1-month follow-up - Baseline (T3-T1) | 0.12 m/s | Standard Error 0.13 |
| Gait Training Group | Gait Speed During the Dual Task | After 4 weeks of training (T2) | 0.82 m/s | Standard Error 0.24 |
| Gait Training Group | Gait Speed During the Dual Task | 1-month follow-up (T3) | 0.82 m/s | Standard Error 0.23 |
| Control Group | Gait Speed During the Dual Task | 1-month follow-up (T3) | 0.68 m/s | Standard Error 0.18 |
| Control Group | Gait Speed During the Dual Task | After 4 weeks of training (T2) | 0.62 m/s | Standard Error 0.19 |
| Control Group | Gait Speed During the Dual Task | After 4 weeks of training - Baseline (T2-T1) | -0.02 m/s | Standard Error 0.07 |
| Control Group | Gait Speed During the Dual Task | Baseline (T1) | 0.64 m/s | Standard Error 0.18 |
| Control Group | Gait Speed During the Dual Task | 1-month follow-up - Baseline (T3-T1) | 0.04 m/s | Standard Error 0.1 |
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AOT With Gait Training Group | Gait Speed During the Single Task | 1-month follow-up (T3) | 1.01 m/s | Standard Deviation 0.15 |
| AOT With Gait Training Group | Gait Speed During the Single Task | After 4 weeks of training - Baseline (T2-T1) | 0.17 m/s | Standard Deviation 0.1 |
| AOT With Gait Training Group | Gait Speed During the Single Task | Baseline (T1) | 0.86 m/s | Standard Deviation 0.16 |
| AOT With Gait Training Group | Gait Speed During the Single Task | 1-month follow-up - Baseline (T3-T1) | 0.15 m/s | Standard Deviation 0.09 |
| AOT With Gait Training Group | Gait Speed During the Single Task | After 4 weeks of training (T2) | 1.02 m/s | Standard Deviation 0.15 |
| Gait Training Group | Gait Speed During the Single Task | 1-month follow-up - Baseline (T3-T1) | 0.12 m/s | Standard Deviation 0.08 |
| Gait Training Group | Gait Speed During the Single Task | 1-month follow-up (T3) | 1.06 m/s | Standard Deviation 0.1 |
| Gait Training Group | Gait Speed During the Single Task | After 4 weeks of training (T2) | 1.03 m/s | Standard Deviation 0.1 |
| Gait Training Group | Gait Speed During the Single Task | After 4 weeks of training - Baseline (T2-T1) | 0.09 m/s | Standard Deviation 0.12 |
| Gait Training Group | Gait Speed During the Single Task | Baseline (T1) | 0.94 m/s | Standard Deviation 0.14 |
| Control Group | Gait Speed During the Single Task | 1-month follow-up (T3) | 0.87 m/s | Standard Deviation 0.17 |
| Control Group | Gait Speed During the Single Task | After 4 weeks of training - Baseline (T2-T1) | 0.00 m/s | Standard Deviation 0.08 |
| Control Group | Gait Speed During the Single Task | 1-month follow-up - Baseline (T3-T1) | -0.01 m/s | Standard Deviation 0.1 |
| Control Group | Gait Speed During the Single Task | After 4 weeks of training (T2) | 0.88 m/s | Standard Deviation 0.15 |
| Control Group | Gait Speed During the Single Task | Baseline (T1) | 0.88 m/s | Standard Deviation 0.15 |
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AOT With Gait Training Group | Montreal Cognitive Assessment (MoCA) | After 4 weeks of training (T2) | 24.64 scores | Standard Deviation 2.34 |
| AOT With Gait Training Group | Montreal Cognitive Assessment (MoCA) | Baseline (T1) | 22.18 scores | Standard Deviation 1.47 |
| AOT With Gait Training Group | Montreal Cognitive Assessment (MoCA) | After 4 weeks of training - Baseline (T2-T1) | 2.45 scores | Standard Deviation 1.63 |
| AOT With Gait Training Group | Montreal Cognitive Assessment (MoCA) | 1-month follow-up - Baseline (T3-T1) | 4.64 scores | Standard Deviation 1.86 |
| AOT With Gait Training Group | Montreal Cognitive Assessment (MoCA) | 1-month follow-up (T3) | 26.82 scores | Standard Deviation 2.04 |
| Gait Training Group | Montreal Cognitive Assessment (MoCA) | Baseline (T1) | 22.64 scores | Standard Deviation 1.36 |
| Gait Training Group | Montreal Cognitive Assessment (MoCA) | After 4 weeks of training - Baseline (T2-T1) | 1.36 scores | Standard Deviation 2.69 |
| Gait Training Group | Montreal Cognitive Assessment (MoCA) | 1-month follow-up - Baseline (T3-T1) | 2.36 scores | Standard Deviation 2.8 |
| Gait Training Group | Montreal Cognitive Assessment (MoCA) | After 4 weeks of training (T2) | 24.00 scores | Standard Deviation 2.86 |
| Gait Training Group | Montreal Cognitive Assessment (MoCA) | 1-month follow-up (T3) | 25.00 scores | Standard Deviation 3.16 |
| Control Group | Montreal Cognitive Assessment (MoCA) | 1-month follow-up (T3) | 24.54 scores | Standard Deviation 2.91 |
| Control Group | Montreal Cognitive Assessment (MoCA) | After 4 weeks of training (T2) | 24.45 scores | Standard Deviation 2.91 |
| Control Group | Montreal Cognitive Assessment (MoCA) | After 4 weeks of training - Baseline (T2-T1) | 2.27 scores | Standard Deviation 1.9 |
| Control Group | Montreal Cognitive Assessment (MoCA) | Baseline (T1) | 22.18 scores | Standard Deviation 1.94 |
| Control Group | Montreal Cognitive Assessment (MoCA) | 1-month follow-up - Baseline (T3-T1) | 2.36 scores | Standard Deviation 2.29 |
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AOT With Gait Training Group | Stride Time Variability During Dual Task | After 4 weeks of training - Baseline (T2-T1) | -1.41 % Cov | Standard Deviation 2.5 |
| AOT With Gait Training Group | Stride Time Variability During Dual Task | After 4 weeks of training (T2) | 3.89 % Cov | Standard Deviation 2.29 |
| AOT With Gait Training Group | Stride Time Variability During Dual Task | 1-month follow-up - Baseline (T3-T1) | -1.57 % Cov | Standard Deviation 2.76 |
| AOT With Gait Training Group | Stride Time Variability During Dual Task | Baseline (T1) | 5.30 % Cov | Standard Deviation 3.9 |
| AOT With Gait Training Group | Stride Time Variability During Dual Task | 1-month follow-up (T3) | 3.73 % Cov | Standard Deviation 2.06 |
| Gait Training Group | Stride Time Variability During Dual Task | 1-month follow-up - Baseline (T3-T1) | -1.15 % Cov | Standard Deviation 1.9 |
| Gait Training Group | Stride Time Variability During Dual Task | 1-month follow-up (T3) | 4.19 % Cov | Standard Deviation 4.85 |
| Gait Training Group | Stride Time Variability During Dual Task | Baseline (T1) | 5.34 % Cov | Standard Deviation 4.93 |
| Gait Training Group | Stride Time Variability During Dual Task | After 4 weeks of training (T2) | 4.95 % Cov | Standard Deviation 5.95 |
| Gait Training Group | Stride Time Variability During Dual Task | After 4 weeks of training - Baseline (T2-T1) | -0.38 % Cov | Standard Deviation 2.63 |
| Control Group | Stride Time Variability During Dual Task | After 4 weeks of training - Baseline (T2-T1) | 0.93 % Cov | Standard Deviation 3.18 |
| Control Group | Stride Time Variability During Dual Task | 1-month follow-up - Baseline (T3-T1) | 1.20 % Cov | Standard Deviation 3.55 |
| Control Group | Stride Time Variability During Dual Task | After 4 weeks of training (T2) | 6.34 % Cov | Standard Deviation 4.4 |
| Control Group | Stride Time Variability During Dual Task | 1-month follow-up (T3) | 6.61 % Cov | Standard Deviation 3.74 |
| Control Group | Stride Time Variability During Dual Task | Baseline (T1) | 5.41 % Cov | Standard Deviation 2.63 |
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AOT With Gait Training Group | Stride Time Variability During Single Task | After 4 weeks of training (T2) | 2.48 %Cov | Standard Deviation 0.73 |
| AOT With Gait Training Group | Stride Time Variability During Single Task | Baseline (T1) | 2.42 %Cov | Standard Deviation 1.15 |
| AOT With Gait Training Group | Stride Time Variability During Single Task | After 4 weeks of training - Baseline (T2-T1) | 0.06 %Cov | Standard Deviation 1.49 |
| AOT With Gait Training Group | Stride Time Variability During Single Task | 1-month follow-up - Baseline (T3-T1) | -0.09 %Cov | Standard Deviation 1.73 |
| AOT With Gait Training Group | Stride Time Variability During Single Task | 1-month follow-up (T3) | 2.33 %Cov | Standard Deviation 0.89 |
| Gait Training Group | Stride Time Variability During Single Task | Baseline (T1) | 1.85 %Cov | Standard Deviation 0.78 |
| Gait Training Group | Stride Time Variability During Single Task | After 4 weeks of training - Baseline (T2-T1) | 0.01 %Cov | Standard Deviation 0.89 |
| Gait Training Group | Stride Time Variability During Single Task | 1-month follow-up - Baseline (T3-T1) | -0.05 %Cov | Standard Deviation 1.19 |
| Gait Training Group | Stride Time Variability During Single Task | After 4 weeks of training (T2) | 1.86 %Cov | Standard Deviation 0.71 |
| Gait Training Group | Stride Time Variability During Single Task | 1-month follow-up (T3) | 1.80 %Cov | Standard Deviation 0.72 |
| Control Group | Stride Time Variability During Single Task | 1-month follow-up (T3) | 2.33 %Cov | Standard Deviation 1.12 |
| Control Group | Stride Time Variability During Single Task | After 4 weeks of training (T2) | 2.87 %Cov | Standard Deviation 1.21 |
| Control Group | Stride Time Variability During Single Task | After 4 weeks of training - Baseline (T2-T1) | 0.20 %Cov | Standard Deviation 0.95 |
| Control Group | Stride Time Variability During Single Task | Baseline (T1) | 2.67 %Cov | Standard Deviation 0.98 |
| Control Group | Stride Time Variability During Single Task | 1-month follow-up - Baseline (T3-T1) | -0.34 %Cov | Standard Deviation 0.69 |