ClinicalTrials.gov record NCT06936163

A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age10 years old to 45 years old
SexAll
LocationChina
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 is a prospective, single-center observational study following people with hereditary spastic paraplegia (HSP) who undergo surgery for foot deformities. About 100 participants aged 10–45 with HSP-related Achilles tendon contracture or equinovarus cavus foot deformity that did not respond adequately to conservative treatment will be followed for two years. The study records clinical function, pain, foot posture, walking ability, and spasticity at planned intervals.

What it is studying. The study tests long-term outcomes and risks after surgical correction of HSP-related foot deformities. It also aims to identify the best timing for surgery and to develop objective evaluation criteria using repeated measures of ankle-foot function, pain, foot posture, walking distance, and spasticity over 24 months.

What the researchers hope to learn. To summarize clinical experience with surgical correction of HSP-associated foot deformities; to assess long-term functional outcomes and risks; to determine optimal timing for surgery; and to establish objective criteria to guide treatment decisions.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Through a prospective cohort study, we aim to dynamically evaluate the long-term benefits and risks associated with surgical interventions for hereditary spastic paraparesis (HSP) accompanied by foot deformities. Our goal is to systematically summarize clinical experiences to guide practice and ultimately optimize patient outcomes. The core research objectives include elucidating:

  • the long-term efficacy of foot deformity correction procedures;
  • the optimal timing for surgical intervention;
  • the establishment of objective evaluation criteria to guide therapeutic decision-making.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age: 10 to 45 years old.
  • Clinically and molecular genetically confirmed diagnosis of hereditary spastic paraparesis (HSP) with either isolated Achilles tendon contracture or equinovarus cavus deformity.
  • Radiographic (X-ray) or computed tomography (CT) evidence confirming the presence of isolated Achilles tendon contracture or equinovarus cavus deformity.
  • Signed informed consent form by patients/legal guardians for voluntary participation in the clinical study, with full comprehension of and commitment to study protocols .
  • Suboptimal response to standard conservative treatments (pharmacotherapy and/or rehabilitative exercise programs) with progressive worsening of gait abnormalities and foot deformities .
  • Functional impairment secondary to isolated Achilles tendon contracture or equinovarus cavus deformity, manifesting as ambulatory pain, frequent falls, and significant quality-of-life limitations.
  • Ability to ambulate barefoot for 10 meters independently or with assistive devices.

Exclusion criteria

  • Prior history of foot and ankle orthopedic surgery.
  • Severe cognitive impairment or an inability to adhere to postoperative protocols and functional assessments.
  • Isolated Achilles tendon contracture or equinovarus cavus deformity resulting from definitive etiologies (e.g., diabetes mellitus, infectious arthritis, or inflammatory arthropathy).
  • Significant peripheral vascular disease or clinically significant unstable medical conditions, including malignancies, hematologic disorders, and cardiopulmonary, hepatic, or renal insufficiency.
  • Coexisting neurodegenerative or neuromuscular disorders that are unrelated to hereditary spastic paraplegia (HSP).
  • Poor compliance with study requirements or other contraindications to participation in clinical trials.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Hereditary spastic paraplegia (HSP) is a neurodegenerative disorder characterized by axonal degeneration of the corticospinal tract. This degeneration often leads to foot deformities such as equinovarus, cavus foot, and Achilles tendon contracture, which result from lower limb spasticity and muscular imbalance. These deformities result in gait abnormalities, uneven plantar pressure distribution, and secondary osteoarticular damage, which significantly impair motor function and quality of life. Surgical correction serves as the primary intervention to address fixed deformities and delay disease progression.This prospective, open-label, single-center study aims to evaluate the long-term functional outcomes of surgical treatment for HSP-related foot deformities, determine the optimal timing for surgical intervention, and establish objective evaluation criteria. Over a 2-year period, 100 patients aged 10-45 years with HSP-confirmed isolated Achilles tendon contracture or equinovarus cavus foot deformity will be enrolled in the study. Eligible patients must exhibit progressive deformity refractory to conservative therapy, accompanied by walking pain, frequent falls, and significant quality-of-life impairment. They must also retain the ability to walk independently or with assistive devices for at least 10 meters. All participants will undergo regular clinical assessments.

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.

Participants will have the planned surgical correction for their foot deformity as part of their care and then attend regular postoperative assessments. Follow-up includes clinical exams, questionnaires and functional tests such as the AOFAS score, pain (VAS), Foot Posture Index, 6‑minute walk test, Spastic Paraplegia Rating Scale, and the GMFM‑88 for minors. Assessments are scheduled at about 1, 3, 6, 12, 18, and 24 months after treatment. All participants must be able to complete the required visits and tests.

How the study is structured. A prospective observational cohort: people with HSP and specified foot deformities who undergo surgical correction as clinical care are followed at set visits (1, 3, 6, 12, 18, and 24 months). Single-center and open-label, the study collects clinical assessments and outcome scores without assigning experimental treatments.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. 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

Clinical trials21 trials listed for hereditary spastic paraplegiaEvery trial the registry lists for hereditary spastic paraplegia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hereditary spastic paraplegia researchLatest monthly update: September 2026. Includes: SPTSSA treatment signal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 1, 2025
Primary completion
Mar 31, 2027 (estimated)
Study completion
Apr 30, 2027 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Apr 20, 2025
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
Shanghai 6th People's Hospital
Principal investigator
Li Cao, Professor
Shanghai 6th People's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

    Shanghai, Shanghai Municipality, 213000 · China

Terms used on this page · explanations by MedicalUpdates.ai

prospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
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.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.

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.

← Back to clinical trials