- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07705360
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial (MI-TURN)
Motor Imagery and Turning Practice to Improve Mobility: MI-TURN Pilot Trial
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 65 years or older.
- Self-report difficulty with turning, balance, or walking-related mobility tasks.
- Self-report increased fall risk, including a history of falls, fall-related injury, multiple falls within the previous year, or fear of falling due to balance or walking concerns.
- Report some difficulty with walking-related activities, such as turning, walking longer distances, climbing stairs, or completing household activities.
- Willingness to be randomized to either study group and complete all study procedures.
- Living independently in the community and able to travel to the research site.
- Ability to perform motor imagery, defined by a qualifying score on the Motor Imagery Questionnaire - Revised Second Version.
- Access to an internet-connected computer capable of playing videos with sound in a quiet environment.
- Ability to provide informed consent.
Exclusion Criteria:
- Diagnosis or symptoms of a neurological disorder or central nervous system injury, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, or stroke.
- Contraindications to transcranial magnetic stimulation (TMS) or non-invasive brain stimulation procedures.
- Use of medications known to substantially affect central nervous system function.
- Severe arthritis or musculoskeletal impairment that would limit safe participation in mobility training.
- Severe obesity (body mass index greater than 35 kg/m²).
- Significant cardiovascular, pulmonary, renal, or other uncontrolled medical conditions that may limit safe participation.
- Myocardial infarction or major cardiac surgery within the previous year.
- Cancer treatment within the previous year, excluding nonmelanoma skin cancer or cancers with excellent prognosis.
- Uncontrolled hypertension at rest (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg).
- Bone fracture or joint replacement within the previous 6 months.
- Current participation in physical therapy or cardiopulmonary rehabilitation targeting lower extremity function.
- Current enrollment in another clinical trial that may interfere with study participation or outcomes.
- Inability to communicate effectively with study personnel or inability to understand English-language study procedures.
- Plans to relocate from the area during the study period.
- Any additional safety or compliance concerns identified by the investigative team.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Loco+MIT
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.
|
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Loco+SME
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Retention Rate (Feasibility)
Time Frame: Post 1-Month Assessment Visit
|
Percentage of enrolled participants who complete the 1-month post-intervention assessment.
|
Post 1-Month Assessment Visit
|
|
Participant Attendance Rate (Feasibility)
Time Frame: Baseline through the 1-month post-intervention assessment (approximately 11 weeks).
|
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
Time Frame: Baseline to 1-week post-intervention (approximately seven weeks between assessments)
|
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
Time Frame: Baseline to 1-week post-intervention (approximately seven weeks between assessments)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Free-Living Physical Activity - Daily Step Count
Time Frame: Baseline to 1-week post-intervention
|
Change in average daily step count measured using an activity monitor.
|
Baseline to 1-week post-intervention
|
|
Free-Living Physical Activity - Time Spent Sedentary
Time Frame: Baseline to 1-week post-intervention
|
Change in average time spend sedentary measured using an activity monitor.
|
Baseline to 1-week post-intervention
|
|
Duration of Cortical Silent Period (cSP) (ms)
Time Frame: Change from baseline to 1-week post-intervention (approximately seven weeks after baseline)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Up and Go Test
Time Frame: Baseline and approximately 1-week after the final intervention session (+/- three days).
|
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
Time Frame: Baseline and approximately 1-week after the final intervention session (+/- three days)
|
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)
Time Frame: Change from baseline to 1-week post-intervention (approximately 7 weeks after baseline).
|
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
Time Frame: Change from baseline to 1-week post-intervention (approximately 7 weeks after baseline).
|
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
Time Frame: Baseline and 1-week following the final intervention session (+/- 3 days)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB26-071
- 5P20GM148321 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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