Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 213000, China
Location status: Recruiting
NCT Number: NCT06936163
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.
Interested in participating?
Request Info10 year–45 year
All sexes
Observational
Shanghai, Shanghai Municipality, 213000, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
The quantitative assessment of ankle-foot function,directly reflects the long-term improvement in foot functionality following surgical intervention, serving as a critical indicator of therapeutic efficacy.
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
The Visual Analog Scale (VAS) is a standardized tool for quantifying subjective symptoms (including pain and discomfort), serving as a critical indicator of surgical efficacy in alleviating foot pain in patients with Hereditary Spastic Paraplegia (HSP).
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
The Foot Posture Index (FPI) is a quantitative tool for assessing foot posture, designed to objectively evaluate the severity of foot alignment abnormalities.
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
The 6-MWT measures the distance a person can walk in six minutes. A shorter distance indicates lower exercise capacity
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
The change in the Spastic Paraplegia Rating Scale (SPRS) score : range: 0-52, higher scores mean a worse outcome
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Gross Motor Function Measure-88 (GMFM-88) score: range: 0-264, higher scores mean a better outcome
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Montreal Cognitive Assessment (MoCA) score: range: 0-30, higher scores mean a better outcome.
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Mini-Mental State Examination (MMSE) : range: 0-30, higher scores mean a better outcome.
Contact information is provided by the study sponsor or research team.
Li Cao, phD
CONTACT
Wo tu Tian, phD
CONTACT
Shanghai 6th People's Hospital
Other
Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study
Acronym: HSP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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