NCT06936163 A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
| NCT ID | NCT06936163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-03-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: 1. the long-term efficacy of foot deformity correction procedures; 2. the optimal timing for surgical intervention; 3. the establishment of objective evaluation criteria to guide therapeutic decision-making.
Eligibility Criteria
Inclusion Criteria: 1. Age: 10 to 45 years old. 2. Clinically and molecular genetically confirmed diagnosis of hereditary spastic paraparesis (HSP) with either isolated Achilles tendon contracture or equinovarus cavus deformity. 3. Radiographic (X-ray) or computed tomography (CT) evidence confirming the presence of isolated Achilles tendon contracture or equinovarus cavus deformity. 4. Signed informed consent form by patients/legal guardians for voluntary participation in the clinical study, with full comprehension of and commitment to study protocols . 5. Suboptimal response to standard conservative treatments (pharmacotherapy and/or rehabilitative exercise programs) with progressive worsening of gait abnormalities and foot deformities . 6. Functional impairment secondary to isolated Achilles tendon contracture or equinovarus cavus deformity, manifesting as ambulatory pain, frequent falls, and significant quality-of-life limitations. 7. Ability to ambulate barefoot for 10 meters independently or with assistive devices. Exclusion Criteria: 1. Prior history of foot and ankle orthopedic surgery. 2. Severe cognitive impairment or an inability to adhere to postoperative protocols and functional assessments. 3. Isolated Achilles tendon contracture or equinovarus cavus deformity resulting from definitive etiologies (e.g., diabetes mellitus, infectious arthritis, or inflammatory arthropathy). 4. Significant peripheral vascular disease or clinically significant unstable medical conditions, including malignancies, hematologic disorders, and cardiopulmonary, hepatic, or renal insufficiency. 5. Coexisting neurodegenerative or neuromuscular disorders that are unrelated to hereditary spastic paraplegia (HSP). 6. Poor compliance with study requirements or other contraindications to participation in clinical trials.
Contact & Investigator
Li Cao, phD
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Frequently Asked Questions
Who can join the NCT06936163 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 45 Years, studying Hereditary Spastic Paraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936163 currently recruiting?
Yes, NCT06936163 is actively recruiting participants. Contact the research team at caoli2000@yeah.net for enrollment information.
Where is the NCT06936163 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06936163 clinical trial?
NCT06936163 is sponsored by Shanghai 6th People's Hospital. The principal investigator is Li Cao, phD at Shanghai Jiao Tong University Affiliated Sixth People's Hospital. The trial plans to enroll 100 participants.