Hereditary Spastic ParaplegiaHSPMOVENCT07561359
12-Week Strength and Functional Exercise Program for Hereditary Spastic Paraplegia Trial (HSPMOVE)
A study testing Individualized Functional and Strength Exercises in people with Hereditary Spastic Paraplegia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Hereditary Spastic Paraplegia
- What is being tested?
- Individualized Functional and Strength Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Apr 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: 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.
Read more
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.
- Conditions
- Hereditary Spastic Paraplegia
- Being tested
- Individualized Functional and Strength Exercises
- Keywords
- Hereditary spastic paraplegia, rehabilitation, exercise, Physical Therapy
- Medical subject headings
- Spastic Paraplegia, Hereditary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Functional and Strength ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Functional and Strength Exercise Intervention | Experimental | Individualized functional and strength exercise intervention delivered via videoconference and supervised by a physiotherapist. Receives: Other: Individualized Functional and Strength Exercises |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 and 24 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start27 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Spastic ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind, 1:1 randomized crossover adaptive study. Participants remain in their assigned group for 12 weeks, then cross over without washout, totaling 24 weeks (12 intervention, 12 control). The primary analysis compares pre-post response slopes after 12 weeks of active treatment versus control, using an intention-to-treat approach with a 2:1 treated-to-control proportion. The control period in those initially treated will be used to explore detraining effects and post hoc analyses. Twenty patients with hereditary spastic paraplegia (HSP) will be randomized and analyzed after 24 weeks. Sample size adaptation will be based on interim analyses at 12 and 24 weeks, considering three zones: favorable, promising (p\<0.2), or unfavorable (p\>0.2 or worse outcomes). Adaptation decisions will require at least one primary and one additional outcome (primary or secondary). No correction for multiple comparisons will be applied.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561359
- Sponsor's protocol ID
- 2023-0040
- Other IDs
- CAAE: 67528023.6.0000.5327
- Acronym
- HSPMOVE
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37811319
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-Week Strength and Functional Exercise Protocol for Treating Motor Symptoms in Individuals With Hereditary Spastic Paraplegia: Adaptive Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07561359
- Acronym / sponsor ID
- HSPMOVE / 2023-0040
- Conditions
- Hereditary Spastic Paraplegia
- Keywords
- Hereditary spastic paraplegia, rehabilitation, exercise, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, 1:1 randomized crossover adaptive study. Participants remain in their assigned group for 12 weeks, then cross over without washout, totaling 24 weeks (12 intervention, 12 control). The primary analysis compares pre-post response slopes after 12 weeks of active treatment versus control, using an intention-to-treat approach with a 2:1 treated-to-control proportion. The control period in those initially treated will be used to explore detraining effects and post hoc analyses. Twenty patients with hereditary spastic paraplegia (HSP) will be randomized and analyzed after 24 weeks. Sample size adaptation will be based on interim analyses at 12 and 24 weeks, considering three zones: favorable, promising (p<0.2), or unfavorable (p>0.2 or worse outcomes). Adaptation decisions will require at least one primary and one additional outcome (primary or secondary). No correction for multiple comparisons will be applied.
| Arm | Type | Receives |
|---|---|---|
| Individualized Functional and Strength Exercise Intervention | Experimental | Other: Individualized Functional and Strength ExercisesIndividualized functional and strength exercise intervention delivered via videoconference and supervised by a physiotherapist. |
| 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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Functional and Strength ExercisesIndividualized 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. | Other | Individualized Functional and Strength Exercise Intervention |
Primary outcome
Spastic Paraplegia Rating Scale (SPRS)
Time frame: Baseline, 12 and 24 weeks
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.
Timed Up and Go Test (TUG) - maximum walking speed
Time frame: Baseline, 12 and 24 weeks
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.
Goal Attainment Scaling (GAS)
Time frame: Baseline, 12 and 24 weeks
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.
8 secondary outcomes
10-Meter Walk Test (10MWT) - self-selected walking speed
Time frame: Baseline, 12 and 24 weeks
10-Meter Walk Test (10MWT) - maximum walking speed
Time frame: Baseline, 12 and 24 weeks
Timed Up and Go (TUG) - self-selected walking speed
Time frame: Baseline, 12 and 24 weeks
Falls Efficacy scale - International (Brazilian Portuguese)
Time frame: Baseline, 12 and 24 weeks
36-Item Short Form Health Survey (SF-36) - Brazillian Portuguese
Time frame: Baseline, 12 and 24 weeks
Medical Research Council (MRC) Muscle Strength Scale
Time frame: Baseline, 12 and 24 weeks
Modified Ashworth Scale (MAS)
Time frame: Baseline, 12 and 24 weeks
Patient Global Impression of Change (PGI-C)
Time frame: Baseline, 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 37811319Cubillos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Functional and Strength Exercises in people with Hereditary Spastic Paraplegia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spastic Paraplegia Rating Scale (SPRS) (time frame: Baseline, 12 and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.