ClinicalTrials.gov record NCT07561359
12-Week Strength and Functional Exercise Program for Hereditary Spastic Paraplegia Trial (HSPMOVE)
12-Week Strength and Functional Exercise Protocol for Treating Motor Symptoms in Individuals With Hereditary Spastic Paraplegia: Adaptive Randomized Crossover Clinical Trial
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized crossover trial tests a 12-week individualized strength and functional exercise program delivered by videoconference for people with hereditary spastic paraplegia who can walk independently. Participants take part in two supervised exercise sessions per week during the exercise period and spend an alternate period receiving no real-time supervision but educational materials. All participants experience both the exercise and no-intervention periods in random order; outcome assessments are performed by a blinded evaluator.
What it is studying. Whether a structured, individualized 12-week program of strength, balance, and gait exercises delivered and supervised remotely changes walking ability, lower-limb strength, spasticity, goal attainment, and quality of life in people with hereditary spastic paraplegia.
What the researchers hope to learn. To determine whether the exercise program is safe, feasible, and whether it affects motor symptoms (walking, strength, spasticity), goal attainment, and quality of life in people with HSP.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Individualized Functional and Strength Exercises
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Take part in a 12-week, physiotherapist‑supervised exercise program delivered by videoconference twice weekly (sessions individualized for strength, balance and walking). Because the trial uses a randomized crossover design, each person will also have a comparison period without real‑time supervision (during that time they will receive printed educational materials). Clinical and performance assessments — including walking tests, strength and spasticity measures, Goal Attainment Scaling, and questionnaires about function and quality of life — are done at baseline, 12 weeks and 24 weeks; an evaluator who is blinded to group assignment will perform outcome assessments. No invasive procedures (e.g., biopsies or spinal taps) are listed in the registry.
How the study is structured. Randomized crossover interventional trial: each participant is randomly assigned to start with either the 12-week supervised exercise program or a 12-week no-intervention period (educational materials only), then crosses over to the other period. The exercise is delivered by a physiotherapist via videoconference twice weekly and is individualized. Assessments are done at baseline, 12 weeks, and 24 weeks. The registry lists masking as double and outcome assessors are blinded to group allocation.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in Brazil. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on hereditary spastic paraplegia
Important dates
- Study start
- Apr 27, 2024
- Primary completion
- December 2026 (estimated)
- Study completion
- March 2027 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- May 1, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
Participating sites (1)
- Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003 · Brazil
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- crossover
- Each participant receives more than one intervention, one after the other, usually with a gap (a washout) in between. Participants act as their own comparison.
- blinded
- Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
- allocation
- How participants are assigned to study groups, for example at random or by a non-random rule.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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