This study aims to evaluate whether a 12-week program of strength and functional exercises can improve movement and daily function in people with Hereditary Spastic Paraplegia (HSP). Participants will take part in supervised exercise sessions twice a week, delivered by videoconference, with guidance from a physiotherapist. The exercises will be tailored to each participant's abilities and goals and will focus on improving muscle strength, balance, and walking. The study is a randomized crossover trial, meaning that all participants will experience both the exercise program and a comparison period without the intervention. Eligible participants are individuals aged 16 to 70 years with a clinical or genetically confirmed diagnosis of HSP, who are able to walk independently (with or without assistive devices) and have stable treatment for spasticity. Researchers will measure changes in walking ability, balance, muscle strength, and quality of life using clinical scales and functional tests. These include walking tests, mobility assessments, and questionnaires about daily activities and confidence in movement. To reduce bias, outcome assessments will be performed by an evaluator who is blinded to the participants' group allocation. The results of this study will help determine whether a structured exercise program is safe, feasible, and effective for improving motor symptoms in people with HSP, and may support its use as part of routine care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Individualized functional and strength exercise intervention delivered via videoconference and supervised by a physiotherapist. Exercises are tailored according to Goal Attainment Scaling (GAS) and baseline physical activity level. The program consists of two sessions per week and follows key training principles (individuality, overload, adaptation, specificity, continuity, reversibility, and variability) with progressive loading. The intervention focuses on improving lower limb strength and functional mobility, particularly gait, and includes balance and gait training. Sessions are scheduled with 2-3 day intervals. Each exercise includes 1-3 sets of 8-15 repetitions, with 30-60 seconds rest between sets. Training intensity ranges from 40-60% of maximal strength for sedentary participants and 50-70% for physically active participants.
Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Spastic Paraplegia Rating Scale (SPRS)
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.
Time frame: Baseline, 12 and 24 weeks
Timed Up and Go Test (TUG) - maximum walking speed
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.
Time frame: Baseline, 12 and 24 weeks
Goal Attainment Scaling (GAS)
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.
Time frame: Baseline, 12 and 24 weeks
10-Meter Walk Test (10MWT) - self-selected walking speed
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.
Time frame: Baseline, 12 and 24 weeks
10-Meter Walk Test (10MWT) - maximum walking speed
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.
Time frame: Baseline, 12 and 24 weeks
Timed Up and Go (TUG) - self-selected walking speed
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.
Time frame: Baseline, 12 and 24 weeks
Falls Efficacy scale - International (Brazilian Portuguese)
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.
Time frame: Baseline, 12 and 24 weeks
36-Item Short Form Health Survey (SF-36) - Brazillian Portuguese
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.
Time frame: Baseline, 12 and 24 weeks
Medical Research Council (MRC) Muscle Strength Scale
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.
Time frame: Baseline, 12 and 24 weeks
Modified Ashworth Scale (MAS)
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.
Time frame: Baseline, 12 and 24 weeks
Patient Global Impression of Change (PGI-C)
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.
Time frame: Baseline, 12 and 24 weeks
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