NCT07705360

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
30mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

May 26, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Motor ImageryLocomotor TrainingMobilityOlder AdultsTranscranial Magnetic StimulationTurning PerformancePhysical Activity

Outcome Measures

Primary Outcomes (4)

  • 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)

Secondary Outcomes (3)

  • Free-Living Physical Activity - Daily Step Count

    Baseline to 1-week post-intervention

  • Free-Living Physical Activity - Time Spent Sedentary

    Baseline to 1-week post-intervention

  • Duration of Cortical Silent Period (cSP) (ms)

    Change from baseline to 1-week post-intervention (approximately seven weeks after baseline)

Other Outcomes (5)

  • Time Up and Go Test

    Baseline and approximately 1-week after the final intervention session (+/- three days).

  • TabCAT Cognitive Assessment

    Baseline and approximately 1-week after the final intervention session (+/- three days)

  • Activities-Specific Balance Confidence (ABC)

    Change from baseline to 1-week post-intervention (approximately 7 weeks after baseline).

  • +2 more other outcomes

Study Arms (2)

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.

Behavioral: Motor Imagery TherapyBehavioral: Locomotor Turning Practice

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.

Behavioral: Stress Management EducationBehavioral: Locomotor Turning Practice

Interventions

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.

Also known as: MIT
Loco+MIT

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.

Also known as: SME
Loco+SME

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.

Also known as: LOCO
Loco+MITLoco+SME

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Study personnel conducting outcome assessments will be blinded to intervention assignment. Participants and intervention staff will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 26, 2026

First Posted

July 15, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF
Time Frame
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.
Access Criteria
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.