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Enrolling by invitation NCT07561359

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

No phase Interventional Hereditary Spastic Paraplegia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized Functional and Strength Exercises.
Who it may be relevant to
Registry conditions: Hereditary Spastic Paraplegia. Basic parameters: 16 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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 fun

Primary outcome measures

  • Spastic Paraplegia Rating Scale (SPRS) [Time frame: Baseline, 12 and 24 weeks]
  • Timed Up and Go Test (TUG) - maximum walking speed [Time frame: Baseline, 12 and 24 weeks]
  • Goal Attainment Scaling (GAS) [Time frame: Baseline, 12 and 24 weeks]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre — Porto Alegre

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. PMID 37811319

Identifiers

NCT: NCT07561359 · 2023-0040 · CAAE: 67528023.6.0000.5327

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗