Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia

NCT06742697 | Recruiting

• 1 other identifier: 1130
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Hereditary Spastic Paraplegia (HSP) is a diverse group of genetic neurological conditions causing progressive weakness and spasticity in the lower limbs, severely reducing balance and gait capabilities. There is currently a lack of structured neurorehabilitation programs aimed at improving gait in adults with HSP. This protocol seeks to assess the feasibility and effectiveness of a structured training approach focusing on flexibility, muscle strength, motor control, balance, and aerobic capacity. To this end, twenty adults diagnosed with HSP will engage in 10 to 16 sessions, each lasting 60 to 120 minutes, guided by a therapist once or twice a week, depending on individual preferences. At the end of the program, participants will receive a transfer package, including written instructions (a manual) and video tutorials, to encourage ongoing exercise at home. Assessments will occur before the intervention (T0), immediately after (T1), and three months later (T2). The primary outcomes will measure the feasibility of the program, including recruitment, retention, adherence, the absence of adverse events, and patient satisfaction. Secondary outcomes will focus on improvements in gait capabilities such as gait endurance and gait speed.

Conditions

Hereditary Spastic Paraplegia

Keywords

feasibility; gait; endurance; speed; balance; neurorehabilitation; hereditary spastic paraplegia; motor learning; aerobic exercise; high intensity interval training; resistance training; flexibility training; gait training

Outcome Measures

Primary Outcomes (4)

• Feasibility (recruitment rate).

  Study feasibility in terms of achieving sufficient recruitment rate, defined as the enrollment of 20 patients within 24 months from the start of the study.

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1).

• Feasibility (adherence rate).

  Study feasibility in terms of achieving adequate adherence to the treatment plan, defined as completing at least 75% of the scheduled treatment sessions, and in any case a minimum of 10 treatment sessions.

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1).

• Feasibility (retention rate).

  Study feasibility in terms of achieving sufficient patient retention, defined as at least 75% of the enrolled patients completing the study with adequate adherence to the treatment.

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1).

• Feasibility (safety).

  Study feasibility in terms of absence of any serious adverse event related to patient participation in the study.

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1).

Secondary Outcomes (2)

• Six Minute Walking Test (6MWT).

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1), follow-up 12 weeks after T1 (T2).

• Ten Metre Walk Test (10MWT).

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1), follow-up 12 weeks after T1 (T2).

Other Outcomes (7)

• Passive range of motion.

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1), follow-up 12 weeks after T1 (T2).

• Hereditary Spastic Paraplegia - Self Notion and Perception Questionnaire (HSP-SNAP).

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1), follow-up 12 weeks after T1 (T2).

• Functional Reach Test (FRT).

  Enrolment (T0), end of treatment five to ten weeks after T0 (T1), follow-up 12 weeks after T1 (T2).

Study Arms (1)

HSP Cohort

EXPERIMENTAL

The whole cohort of HSP patients will receive the same comprehensive neurorehabilitation program aiming at improving gait capabilities (speed and endurance). The content and the dosis of the treatment will be personalized according to patient's specific needs and preferences.

Behavioral: Flexibility, Resistance, Aerobic, Movement Execution training

Interventions

Flexibility, Resistance, Aerobic, Movement Execution training BEHAVIORAL

Flexibility: static and dynamic stretching combined with sensory, high-frequency electrical stimulation to reduce spasticity and improve mobility. Resistance training: core stability and lower limb strength training in conditions of instability, to improve strength, coordination, and balance. Movement execution training: gait training according to motor learning principles. Aerobic exercise: in the form of high-intensity interval training at the end of each session, to improve cardiovascular status and foster motor learning consolidation (probably due to the release of brain derived neurothrophic factors).

HSP Cohort

Eligibility Criteria

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

You may qualify if:

• Adults diagnosed with Hereditary Spastic Paraplegia.
• Presence of any functional deficit in the lower limbs that affects walking, such as muscle weakness, hypertonia, or balance issues.
• Ability to walk without the need for physical contact with another person, as defined by a Functional Ambulation Category score of 3 or higher.
• Ability to understand simple instructions, comprehend the purpose of the study, willingness to participate and undergo at least 10 treatment sessions, eligible and willing to sign the informed consent.

You may not qualify if:

• Botulinum toxin or surgery to treat lower limb hypertonia in the six months prior to enrollment in the study.
• Contraindications for moderate physical activity, such as stretching exercises, muscle strength training, and aerobic capacity training.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (2)

Scientific Institute, IRCCS E. Medea, Department of Bosisio Parini, Lecco, Italy.

Bosisio Parini, Lombardy, 23842, Italy

RECRUITING

Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy

Pieve di Soligo, Veneto, 31053, Italy

RECRUITING

Related Publications (7)

• Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.

  PMID: 17939776 BACKGROUND

• Crozier J, Roig M, Eng JJ, MacKay-Lyons M, Fung J, Ploughman M, Bailey DM, Sweet SN, Giacomantonio N, Thiel A, Trivino M, Tang A. High-Intensity Interval Training After Stroke: An Opportunity to Promote Functional Recovery, Cardiovascular Health, and Neuroplasticity. Neurorehabil Neural Repair. 2018 Jun;32(6-7):543-556. doi: 10.1177/1545968318766663. Epub 2018 Apr 20.

  PMID: 29676956 BACKGROUND

• Thijs L, Voets E, Denissen S, Mehrholz J, Elsner B, Lemmens R, Verheyden GS. Trunk training following stroke. Cochrane Database Syst Rev. 2023 Mar 2;3(3):CD013712. doi: 10.1002/14651858.CD013712.pub2.

  PMID: 36864008 BACKGROUND

• Maccora S, Torrente A, Di Stefano V, Lupica A, Iacono S, Pilati L, Pignolo A, Brighina F. Non-pharmacological treatment of hereditary spastic paraplegia: a systematic review. Neurol Sci. 2024 Mar;45(3):963-976. doi: 10.1007/s10072-023-07200-1. Epub 2023 Nov 16. No abstract available.

  PMID: 37968432 BACKGROUND

• Bellofatto M, De Michele G, Iovino A, Filla A, Santorelli FM. Management of Hereditary Spastic Paraplegia: A Systematic Review of the Literature. Front Neurol. 2019 Jan 22;10:3. doi: 10.3389/fneur.2019.00003. eCollection 2019.

  PMID: 30723448 BACKGROUND

• Ruano L, Melo C, Silva MC, Coutinho P. The global epidemiology of hereditary ataxia and spastic paraplegia: a systematic review of prevalence studies. Neuroepidemiology. 2014;42(3):174-83. doi: 10.1159/000358801. Epub 2014 Mar 5.

  PMID: 24603320 BACKGROUND

• Boccuni L, Bortolini M, Stefan C, Dal Molin V, Dalla Valle G, Martinuzzi A. Flexibility, Resistance, Aerobic, Movement Execution (FRAME) training program to improve gait capacity in adults with Hereditary Spastic Paraplegia: protocol for a single-cohort feasibility trial. Front Neurol. 2025 Feb 18;16:1441512. doi: 10.3389/fneur.2025.1441512. eCollection 2025.

  PMID: 40040914 DERIVED

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary

Interventions

Pliability

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

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Leonardo Boccuni, PhD

  Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo Boccuni, PhD

CONTACT

003904384141; leonardo.boccuni@lanostrafamiglia.it

Marco Bortolini, BSc

CONTACT

003904389062; marco.bortolini@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-cohort feasibility trial.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 19, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start Date: June 2027. End Date: June 2037.
• Access Criteria: Any researcher accredited by non-profit clinical and research centre.

Locations

IT (2)