NCT06936163

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hereditary Spastic Paraplegia

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-31
• Completion: 2027-04-30
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: China