Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial

Официальное название

Motor Imagery and Turning Practice to Improve Mobility: MI-TURN Pilot Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Motor Imagery Therapy
  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.
• Поведенческое Stress Management Education
  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.
• Поведенческое Locomotor Turning Practice
  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.

Первичные конечные точки

• Participant Retention Rate (Feasibility) [Срок оценки: Post 1-Month Assessment Visit]
• Participant Attendance Rate (Feasibility) [Срок оценки: Baseline through the 1-month post-intervention assessment (approximately 11 weeks).]
• Change from Baseline of 360-Degree Turn Duration [Срок оценки: Baseline to 1-week post-intervention (approximately seven weeks between assessments)]
• Change from Baseline of 180-Degree Turn Duration [Срок оценки: Baseline to 1-week post-intervention (approximately seven weeks between assessments)]

Вторичные конечные точки (3)

• Free-Living Physical Activity - Daily Step Count [Срок оценки: Baseline to 1-week post-intervention]
• Free-Living Physical Activity - Time Spent Sedentary [Срок оценки: Baseline to 1-week post-intervention]
• Duration of Cortical Silent Period (cSP) (ms) [Срок оценки: Change from baseline to 1-week post-intervention (approximately seven weeks after baseline)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07705360 · IRB26-071 · 5P20GM148321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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