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

NCT07561359 | Enrolling By Invitation

• 2 other identifiers: 2023-0040CAAE: 67528023.6.0000.5327
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hereditary Spastic Paraplegia

Keywords

Hereditary spastic paraplegia; rehabilitation; exercise; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 10-Meter Walk Test (10MWT) - self-selected walking speed

  Baseline, 12 and 24 weeks

• 10-Meter Walk Test (10MWT) - maximum walking speed

  Baseline, 12 and 24 weeks

• Timed Up and Go (TUG) - self-selected walking speed

  Baseline, 12 and 24 weeks

• Falls Efficacy scale - International (Brazilian Portuguese)

  Baseline, 12 and 24 weeks

• 36-Item Short Form Health Survey (SF-36) - Brazillian Portuguese

  Baseline, 12 and 24 weeks

Other Outcomes (9)

• Handheld Dynamometry (microFET2)

  Baseline, 12 and 24 weeks

• Instrumented Gait Analysis (Opal Sensors System) - Timed Up and Go test

  Baseline, 12 and 24 weeks

• Instrumented Gait Analysis (Opal Sensors System) - Cadence

  Baseline, 12 and 24 weeks

Study Arms (2)

Individualized Functional and Strength Exercise Intervention

EXPERIMENTAL

Individualized functional and strength exercise intervention delivered via videoconference and supervised by a physiotherapist.

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.

Interventions

Individualized Functional and Strength Exercises OTHER

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.

Individualized Functional and Strength Exercise Intervention

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary; Motor Activity

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by two evaluators blinded to group allocation and will take place in person at two distinct time points: pre-intervention and immediately post-intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 1, 2026
• Study Start: April 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)