Actively Recruiting
Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study
Led by Shanghai 6th People's Hospital · Updated on 2025-04-20
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective cohort study to assess the long-term benefits and risks of surgical treatments for foot deformities caused by hereditary spastic paraparesis (HSP). This condition involves nerve degeneration leading to foot problems such as equinovarus, cavus foot, and Achilles tendon contracture, which affect walking and quality of life. The study aims to understand the effectiveness of surgery, the best timing for these procedures, and to develop clear criteria for treatment decisions. The study will enroll 100 patients aged 10 to 45 years with confirmed HSP and progressive foot deformities that have not improved with standard treatments like medication or rehabilitation exercises. All participants will undergo surgical correction of their foot deformities and be followed for two years. The research will focus on the surgical outcomes and aim to optimize timing and evaluation methods for these interventions. Participants will have regular clinical evaluations over a two-year period to monitor their progress. These assessments include scoring systems for foot and ankle function, pain levels, foot posture, walking ability, spasticity severity, and motor function. Observations will be made at 1, 3, 6, 12, 18, and 24 months after treatment to track changes and safety. The study will provide detailed information on how surgery impacts walking, pain, and overall function in HSP patients.
CONDITIONS
Brief Title
A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 10 to 45 years old
- Confirmed diagnosis of hereditary spastic paraparesis (HSP) with isolated Achilles tendon contracture or equinovarus cavus deformity
- Radiographic or CT evidence of the foot deformity
- Signed informed consent with understanding of study protocols
- Poor response to standard conservative treatments with worsening gait and foot deformities
- Functional impairment causing walking pain, frequent falls, and quality-of-life limitations
- Ability to walk barefoot for 10 meters independently or with assistive devices
You will not qualify if you...
- Prior foot or ankle orthopedic surgery
- Severe cognitive impairment or inability to follow postoperative protocols
- Foot deformities caused by other known conditions like diabetes or inflammatory arthritis
- Significant peripheral vascular disease or unstable medical conditions including cancer or organ failure
- Other unrelated neurodegenerative or neuromuscular disorders
- Poor compliance or other contraindications to clinical trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants undergo surgical correction of foot deformities related to hereditary spastic paraplegia and receive immediate post-operative care.
1 visit for surgery and immediate care
Duration - Up to 24 months
Participants attend post-operative assessments to monitor recovery and functional outcomes over time.
Visits at 1, 3, 6, 12, 18, and 24 months post-surgery
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
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