Actively Recruiting
Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia A Prospective Cohort Study Evaluating Long-Term Effects and Timing of Surgery
Led by Shanghai 6th People's Hospital · Updated on 2025-04-20
100
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hereditary spastic paraplegia (HSP) is a neurological disorder that causes nerve damage leading to foot deformities like equinovarus, cavus foot, and Achilles tendon contracture. These deformities cause walking difficulties, uneven foot pressure, and joint damage, which reduce movement ability and quality of life. Researchers are evaluating the long-term benefits and risks of surgical treatments for these foot deformities in people with HSP, aiming to find the best timing for surgery and develop clear standards to guide treatment decisions. This open-label, single-center study will include 100 patients aged 10 to 45 years with confirmed HSP and specific foot deformities resistant to standard non-surgical treatments. All participants will undergo surgical correction to address their fixed deformities. The study will follow these patients over two years to observe how well the surgeries improve foot function and to identify the best time for intervention. Participants will have regular clinical assessments throughout the study, including follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment. Researchers will measure outcomes using the American Orthopaedic Foot and Ankle Society Score to evaluate foot function and monitor improvements. The study focuses on understanding surgery's impact on pain, mobility, gait, and quality of life while ensuring safety and long-term benefits for patients with HSP-related foot deformities.
CONDITIONS
Official Title
A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 and 45 years old
- Confirmed clinical and molecular diagnosis of hereditary spastic paraparesis (HSP) with isolated Achilles tendon contracture or equinovarus cavus deformity
- Imaging evidence (X-ray or CT) confirming the specific foot deformity
- Signed informed consent agreeing to participate in the study
- Poor response to standard non-surgical treatments with worsening gait and foot deformities
- Functional impairments like walking pain, frequent falls, and reduced quality of life due to the foot deformity
- Ability to walk barefoot for at least 10 meters independently or with assistive devices
You will not qualify if you...
- Previous foot or ankle orthopedic surgery
- Severe cognitive problems or inability to follow post-surgery care and assessments
- Foot deformities caused by other conditions such as diabetes, infections, or inflammatory arthritis
- Serious vascular disease or unstable medical issues like cancer, blood disorders, or organ failure
- Other neurodegenerative or neuromuscular diseases not related to HSP
- Poor compliance with study rules or other reasons preventing participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 213000
Actively Recruiting
Research Team
L
Li Cao, phD
W
Wo tu Tian, phD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here