An observational study in Hereditary Spastic Paraplegia, sponsored by Shanghai 6th People's Hospital. Recruiting at 1 site in China. Open to participants aged 10 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Shanghai 6th People's Hospital · Observational
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:
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.
50 studies on the registry are indexed under Spastic Paraplegia, Hereditary; 19 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 25 observational studies indexed under Spastic Paraplegia, Hereditary.
Browse Spastic Paraplegia, Hereditary studies →Shanghai 6th People's Hospital is the lead sponsor of 70 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients meet the clinical and genetic diagnostic criteria of hereditary spastic paraplegia (HSP) between 10 to 45 years old with foot deformities.after undergoing standard conservative management (including pharmacological therapy and rehabilitation exercises) with suboptimal outcomes. Patients agree to participate in clinical trials and able to understand and comply with the research program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged 10 to 45 years who have been diagnosed with isolated Achilles tendon contracture or equinovarus cavus deformity due to hereditary spastic paraparesis (HSP) will be recruited for the study. Eligible participants must have undergone standard conservative treatments, including pharmacological therapy or rehabilitation exercises, but have demonstrated a poor response or progressive worsening of gait disturbances and foot deformities, and be capable of walking barefoot for 10 meters, with or without the use of assistive devices.
American Orthopaedic Foot and Ankle Society Score（AOFAS scores）
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.
Visual Analog Scale (VAS) Score
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.
Foot Posture Index (FPI)
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.
6-Minute Walk Test (6MWT)
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.
Spastic Paraplegia Rating Scale (SPRS)
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) for Minors
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.
MoCA score
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.
MMSE score
Mini-Mental State Examination (MMSE) : 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.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
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Spastic Paraplegia, Hereditary →
Shanghai 6th People's Hospital