12-Week Strength and Functional Exercise Program for Hereditary Spastic Paraplegia Trial (HSPMOVE)

Clinician-reported outcome used to assess disease severity in hereditary spastic paraplegia (HSP). It consists of 13 items evaluating gait, lower limb strength and spasticity, joint contractures, pain, and bladder and bowel function. Total scores range from 0 to 52, with higher scores indicating greater disease severity.

Performance outcome in which participants are instructed to stand up from a seated position, walk 3 meters, turn around, walk back, and sit down at maximum walking speed. The time to complete the task is recorded.

individualized patient reported outcome measure used to assess the extent to which patient-specific goals are achieved during the intervention. Each participant will define four main individualized goals at baseline. Goals and expected levels of performance are defined individually for each participant and scored on a 5-point scale ranging from -2 to +2. A score of 0 represents the expected level of achievement, positive scores (+1, +2) indicate better-than-expected outcomes, and negative scores (-1, -2) indicate less-than-expected outcomes.

Performance outcome in which participants will walk at a comfortable, self-selected pace over a 10-meter distance. A flying start will be used, allowing 2 meters for acceleration and 2 meters for deceleration outside the timed zone. Walking speed (m/s) is calculated based on the time to complete the central 10-meter distance.

Performance outcome in which participants will walk at maximum walking speed over a 10-meter distance. A flying start will be used, allowing 2 meters for acceleration and 2 meters for deceleration outside the timed zone. Walking speed (m/s) is calculated based on the time to complete the central 10-meter distance.

Performance outcome in which participants are instructed to stand up from a seated position, walk 3 meters, turn around, walk back, and sit down at at a comfortable, self-selected pace . The time to complete the task is recorded.

Patient-reported outcome used to assess concern about falling during daily activities in community-dwelling individuals. It consists of 16 items covering functional and participation activities (e.g., sitting/standing from a chair, climbing stairs). Each item is scored from 1 (not at all concerned) to 4 (very concerned), with total scores ranging from 16 to 64. Higher scores indicate greater concern about falling.

Generic, patient-reported outcome of health-related quality of life. It consists of 36 items covering multiple domains, including physical functioning, role limitations due to physical health, pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100, with higher scores indicating better overall health status.

Clinician-reported outcome of muscle strength, graded from 0 (no contraction) to 5 (normal strength). Lower limb muscle groups assessed include hip flexors and extensors, hip abductors and adductors, knee flexors and extensors, and ankle dorsiflexors and plantarflexors.

Clinician-reported outcome used to assess resistance to passive movement and muscle tone. It is scored on a 5-point scale from 0 (normal muscle tone) to 4 (rigid in flexion or extension). In this study, it will be applied to the hip adductor and knee flexor muscles to assess lower limb spasticity.

Patient-reported outcome measuring perceived overall improvement or worsening following the intervention. It is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), capturing the patient's global assessment of change.

Digital health technology in which muscle strength will be assessed using a handheld dynamometer (microFET2) to measure peak force output in lower limb muscle groups including hip flexors and extensors, hip abductors and adductors, knee flexors and extensors, and ankle dorsiflexors and plantarflexors. This provides an objective, quantitative measure of muscle strength (expressed in kgf) for comparison with clinical scales.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Sit-to-stand, turning, and stand-to-sit times in seconds (1 decimal) will be recorded during and Timed Up and Go (TUG) test at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Cadence in steps/min will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Elevation Midswing, Lateral Step Variability, Circumduction in cm will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Gait Cycle Duration and Step Duration in seconds will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Gait Speed in m/s will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Stride Length in meters will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Foot Strike Angle, Toe Off Angle, Toe Out Angle, Lumbar Coronal (RoM), Lumbar Sagittal (RoM), Lumbar Transverse (RoM), Trunk Coronal (RoM), Trunk Sagittal (RoM), Trunk Transverse (RoM) in ° degrees will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.

Digital health technology. Biomechanical gait analysis will be performed using a six-sensor wearable system (Opal, Clario) to capture kinematic and spatiotemporal gait parameters. Double Support, Single Limb Support, Stance, Swing, Terminal Double Support in Gait Cycle Time (%) will be recorded during the 10-Meter Walk Test (10MWT). Data will be collected at both self-selected and maximum walking speeds.