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| ID | Type | Description | Link |
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| 5P20GM148321 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of General Medical Sciences (NIGMS) | NIH |
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The goal of this clinical trial is to evaluate whether combining in-person turning practice with home-based Motor Imagery Therapy (MIT) is feasible and may improve mobility in community-dwelling older adults aged 65 years and older who report balance or turning-related mobility concerns. MIT involves mentally practicing movements and watching movement demonstrations without physically performing the movement.
The main questions this study aims to answer are whether it is feasible for older adults to complete a combined in-person and home-based turning and motor imagery program based on attendance, retention, and activity monitor use; whether adding MIT to a turning intervention improves turning performance more than a comparison program focused on stress management education; whether MIT increases daily physical activity, increases walking intensity, and reduces sedentary time in daily life; and whether measures of brain function related to movement control predict how much participants improve following the intervention.
Researchers will compare a locomotor turning intervention combined with MIT (Loco+MIT) to a locomotor turning intervention combined with stress management education (Loco+SME) to determine whether MIT leads to greater improvements in mobility and daily activity.
Participants will attend five laboratory visits that include mobility testing, brain stimulation assessments, and physical activity assessments. Participants will also complete six weeks of in-person turning practice sessions held twice per week and home-based sessions three times per week consisting of either motor imagery training or stress management education. In addition, participants will wear a physical activity monitor during daily life to measure movement and sedentary behavior and will complete follow-up assessments after the intervention to evaluate changes in mobility and activity over time.
This randomized pilot clinical trial will evaluate the feasibility and preliminary efficacy of combining in-person locomotor turning practice with home-based Motor Imagery Therapy (MIT) in older adults with self-reported balance or turning-related mobility concerns. Turning is a common component of daily mobility and a frequent contributor to falls in older adults, yet it is often underemphasized in traditional rehabilitation programs. MIT is a non-invasive behavioral approach that combines mental rehearsal of movement with action observation to engage brain networks involved in movement planning and motor learning.
Thirty community-dwelling older adults aged 65 years and older will be randomized to either a locomotor turning intervention combined with MIT (Loco+MIT) or a locomotor turning intervention combined with stress management education (Loco+SME). Both groups will complete six weeks of in-person turning practice focused on dynamic turning, weight shifting, and head-trunk coordination. Home-based sessions will be completed on alternating days and will consist of either guided motor imagery and action observation exercises or stress management and wellness education without motor practice components.
The study will evaluate feasibility outcomes including intervention attendance, participant retention, and compliance with remote activity monitoring. Preliminary efficacy outcomes will include turning performance, free-living physical activity, walking intensity, sedentary behavior, and neurophysiological measures related to cortical inhibitory function assessed using transcranial magnetic stimulation (TMS). The study will also explore whether baseline measures of cortical inhibition predict responsiveness to the intervention and whether changes in inhibitory activity are associated with mobility improvements following training.
This study is intended to provide preliminary data regarding the feasibility, safety, and potential benefits of combining motor imagery with locomotor turning practice to support future larger-scale rehabilitation trials targeting mobility and fall risk in older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loco+MIT | Experimental | Participants assigned to this arm will receive six weeks of in-person locomotor turning practice combined with home-based Motor Imagery Therapy. In-person sessions will focus on dynamic turning, weight shifting, and head-trunk coordination. Home-based Motor Imagery Therapy sessions will include guided mental practice and action observation of movement tasks. |
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| Loco+SME | Active Comparator | Participants assigned to this arm will receive the same six weeks of in-person locomotor turning practice combined with home-based Stress Management Education. In-person sessions will focus on dynamic turning, weight shifting, and head-trunk coordination. Home-based Stress Management Education sessions will include educational content related to stress, sleep, and wellness without motor imagery or motor practice components. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor Imagery Therapy | Behavioral | Motor Imagery Therapy (MIT) is a home-based behavioral intervention that combines guided mental rehearsal of movement with action observation. Participants will complete sessions focused on imagining and observing functional mobility tasks and turning-related movements without physically performing the movements. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Retention Rate (Feasibility) | Percentage of enrolled participants who complete the 1-month post-intervention assessment. | Post 1-Month Assessment Visit |
| Participant Attendance Rate (Feasibility) | Percentage of scheduled in-person intervention sessions and home-based sessions completed by participants. | Baseline through the 1-month post-intervention assessment (approximately 11 weeks). |
| Change from Baseline of 360-Degree Turn Duration | The change in time required to complete a 360-degree turn measured using wearable inertial sensors. | Baseline to 1-week post-intervention (approximately seven weeks between assessments) |
| Change from Baseline of 180-Degree Turn Duration | The change in time required to complete a 180-degree turn measured using wearable inertial sensors. | Baseline to 1-week post-intervention (approximately seven weeks between assessments) |
| Measure | Description | Time Frame |
|---|---|---|
| Free-Living Physical Activity - Daily Step Count | Change in average daily step count measured using an activity monitor. | Baseline to 1-week post-intervention |
| Free-Living Physical Activity - Time Spent Sedentary |
| Measure | Description | Time Frame |
|---|---|---|
| Time Up and Go Test | Assessment measuring the time taken to rise from a seated position, walk 3 meters at a comfortable pace, turn 180-degrees, walk back to chair, and sit back down. | Baseline and approximately 1-week after the final intervention session (+/- three days). |
| TabCAT Cognitive Assessment |
Inclusion Criteria:
Exclusion Criteria:
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De-identified individual participant data underlying published study results may be shared, including demographic data, mobility outcomes, physical activity measures, feasibility outcomes, and neurophysiological measures collected during the study.
De-identified individual participant data and supporting documentation will be available beginning approximately 12 months after publication of the primary study findings and may remain available for up to 5 years following publication.
De-identified individual participant data and supporting documentation, including the informed consent form, may be made available to qualified researchers upon reasonable request for purposes of scientific research, secondary analyses, or verification of published findings. Requests will be reviewed by the investigative team and may require a data use agreement in accordance with institutional policies and ethical guidelines. Data shared will exclude direct participant identifiers.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Participants will be randomized to one of two parallel intervention groups: locomotor turning practice combined with Motor Imagery Therapy (MIT) or locomotor turning practice combined with Stress Management Education (SME).
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Study personnel conducting outcome assessments will be blinded to intervention assignment. Participants and intervention staff will not be blinded.
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| Stress Management Education | Behavioral | Stress Management Education (SME) is a home-based educational intervention designed to serve as an active comparison condition. Participants will complete sessions focused on stress management, sleep, wellness, and general health education without motor imagery or movement practice components. |
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| Locomotor Turning Practice | Behavioral | Locomotor Turning Practice is an in-person mobility intervention focused on improving turning performance and dynamic mobility in older adults. Sessions will include structured practice of turning movements, weight shifting, stepping transitions, and head-trunk coordination exercises conducted twice weekly over six weeks. |
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Change in average time spend sedentary measured using an activity monitor.
| Baseline to 1-week post-intervention |
| Duration of Cortical Silent Period (cSP) (ms) | Cortical Silent Period (cSP) duration is a measure of cortical inhibitory function assessed using single-pulse transcranial magnetic stimulation (TMS). The cSP is defined as the duration of stimulus-induced suppression of voluntary muscle activity and is reported in milliseconds (ms). | Change from baseline to 1-week post-intervention (approximately seven weeks after baseline) |
Participants will use an iPad to complete tests looking at different aspects of cognitive function: 1. The Flanker test will be used to assess executive function and inhibition. 2. The Running Dots test will be used to assess executive function and spatial working memory. 3. The Line Orientation test will be used to assess visuospatial function. |
| Baseline and approximately 1-week after the final intervention session (+/- three days) |
| Activities-Specific Balance Confidence (ABC) | The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report questionnaire that measures confidence in performing everyday ambulatory activities without losing balance or becoming unsteady. Scores range from 0 to 100, with higher scores indicating greater balance confidence. | Change from baseline to 1-week post-intervention (approximately 7 weeks after baseline). |
| Mini-BESTest, a 14-item test assessing mobility performance | The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a 14-item clinical assessment of dynamic balance. Total scores range from 0 to 28, with higher scores indicating better balance performance. | Change from baseline to 1-week post-intervention (approximately 7 weeks after baseline). |
| Movement Imagery Questionnaire - Revised Second Version | The Movement Imagery Questionnaire-Revised Second Version (MIQ-RS) is a self-report assessment of motor imagery ability. Scores range from 14 to 98, with higher scores indicating greater motor imagery ability. | Baseline and 1-week following the final intervention session (+/- 3 days) |