治験レーダー

Percentage change in daytime movement of the trained extremity (right or left arm or leg) as measured by 3-axis accelerometer and gyroscope data analyzed via deep-learning neural network

Movement data will be collected using seven Inertial Measurement Units (IMUs) worn continuously for 72 hours at three time points: baseline, 12 weeks (end of intervention), and 24 weeks (follow-up). IMUs will be attached to the sternum, wrists, thighs, and lower legs using adhesive patches and will capture 3-axis accelerometer and gyroscope data. A validated custom neural network (Novosel et al. 2023) will convert signals into images and analyze them using convolutional layers to extract features related to movement behaviors. The primary metric will be the percentage change (minutes a day) in real-world daytime movement of the trained limb, computed relative to baseline. This outcome reflects changes in functional mobility resulting from the motor training intervention.

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Number of daily logins to the tablet app

Attendance will be measured as the number of times participants log into the tablet app during the intervention. Unit of Measure: Number of logins

The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)

Daily session duration recorded in the tablet app

Adherence will be assessed by the average length of each daily training session. This outcome reflects how long participants remain engaged with the motor training program once they log in. Unit of Measure: Minutes

The app stores the data during the intervention period and will be collectedThe app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)

Time spent moving the targeted extremity during training recorded in the tablet app

This measure reflects adherence by quantifying the active movement time of the trained extremity during each training session. Unit of Measure: Minutes

The app stores the data during the intervention period and will be collected The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)

Time spent within target movement intensity threshold recorded in the tablet app

For participants in the Music Motion Feedback group, adherence will also be evaluated by measuring the time spent at or above a predefined movement intensity threshold. Unit of Measure: Minutes

The app stores the data during the intervention period and will be collected The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)

Action Research Arm Test (ARAT) total score - (Upper Extremity)

In participants engaged in upper extremity training, the ARAT will be used to evaluate upper extremity functional capacity. It consists of 19 items assessing grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better arm function. Time Frame: Baseline, 12 weeks (end of intervention), and 24 weeks (follow-up) Unit of Measure: ARAT total score (0-57)

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Maximum isometric arm strength - (Upper Extremity)

Participants engaged in upper extremity training will have the isometric strength of the targeted upper extremity measured using a handheld dynamometer. They will perform maximum voluntary contractions against resistance, and the peak force will be recorded. Unit of Measure: Kilograms of force (kgf)

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Maximum grip strength - (Upper Extremity)

Participants who are engaged in upper extremity training will have their grip strength of the targeted upper limb measured using a hand dynamometer. The highest of three attempts will be recorded. Unit of Measure: Kilograms of force (kgf)

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Gross Motor Function Measure-66 (GMFM-66) total score - (Lower Extremity)

In participants who are engaged in lower extremity training the GMFM-66 will be used to assess gross motor function. It evaluates activities such as standing, walking, and running. Scores range from 0 to 100, with higher scores indicating better function. Unit of Measure: GMFM-66 total score (0-100)

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Maximum isometric leg strength - (Lower Extremity)

The isometric strength of the trained leg will be assessed using a handheld dynamometer. Participants will perform maximum voluntary contractions, and peak force will be recorded. Unit of Measure: Kilograms of force (kgf)

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Distance walked during the Six-Minute Walk Test (6MWT) - (Lower Extremity)

The 6MWT will be used to evaluate walking endurance and aerobic capacity. Participants engaged in lower extremity training will walk as far as possible in six minutes along a flat, indoor course. Time Frame: Baseline, 12 weeks, and 24 weeks Unit of Measure: Meters walked

Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)