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

12-Week Strength and Functional Exercise Protocol for Treating Motor Symptoms in Individuals With Hereditary Spastic Paraplegia: Adaptive Randomized Crossover Clinical Trial

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 Overview

• Status: Enrolling by invitation
• Conditions: Hereditary Spastic Paraplegia
• Intervention / Treatment: Other: Individualized Functional and Strength Exercises

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of hereditary spastic paraplegia confirmed by genetic testing or clinical diagnosis with a positive family history
• Age between 16 and 70 years
• Independent ambulation, with or without assistive devices
• Access to an electronic device (smartphone, tablet, or computer) with camera and internet connection
• Stable therapeutic regimen for spasticity management (pharmacological and/or physiotherapy) for at least 6 months prior to enrollment

Exclusion Criteria:

• Presence of other neurological or systemic conditions causing additional motor impairment or musculoskeletal injury limiting movement
• Inability to perform performance outcomes even with assistive devices
• Planned or ongoing botulinum toxin injections or surgical interventions for spasticity reduction during the 12-week intervention period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized Functional and Strength Exercise Intervention; Individualized functional and strength exercise intervention delivered via videoconference and supervised by a physiotherapist.	Other: Individualized Functional and Strength Exercises; 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.
No Intervention: No Intervention; No individualized prescription or real-time supervision will be provided during this phase. They will receive printed educational materials containing general guidance on performing strength and functional exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Baseline, 12 and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handheld Dynamometry (microFET2)	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Timed Up and Go test	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Cadence	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Elevation Midswing, Lateral Step Variability, Circumduction	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Gait Cycle Duration, Step Duration	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Gait Speed	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Stride Length	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - 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)	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.	Baseline, 12 and 24 weeks
Instrumented Gait Analysis (Opal Sensors System) - Double Support, Single Limb Support, Stance, Swing, Terminal Double Support	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.	Baseline, 12 and 24 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• Cubillos Arcila DM, Dariva Machado G, Martins VF, Leotti VB, Schule R, Peyre-Tartaruga LA, Saute JAM. Long-term progression of clinician-reported and gait performance outcomes in hereditary spastic paraplegias. Front Neurosci. 2023 Sep 22;17:1226479. doi: 10.3389/fnins.2023.1226479. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; Physical Therapy; Hereditary spastic paraplegia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Hereditary Sensory and Motor Neuropathy; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Spastic Paraplegia, Hereditary; Motor Activity
• Other Study ID Numbers: 2023-0040; CAAE: 67528023.6.0000.5327 (Other Identifier: CEP-HCPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No