A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
ConditionHereditary Spastic Paraplegia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-45
SponsorShanghai 6th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 10 to 45 years old.
Clinically and molecular genetically confirmed diagnosis of hereditary spastic paraparesis (HSP) with either isolated Achilles tendon contracture or equinovarus cavus deformity.
Radiographic (X-ray) or computed tomography (CT) evidence confirming the presence of isolated Achilles tendon contracture or equinovarus cavus deformity.
Signed informed consent form by patients/legal guardians for voluntary participation in the clinical study, with full comprehension of and commitment to study protocols .
Disqualifiers
Prior history of foot and ankle orthopedic surgery.
Severe cognitive impairment or an inability to adhere to postoperative protocols and functional assessments.
Isolated Achilles tendon contracture or equinovarus cavus deformity resulting from definitive etiologies (e.g., diabetes mellitus, infectious arthritis, or inflammatory arthropathy).
Significant peripheral vascular disease or clinically significant unstable medical conditions, including malignancies, hematologic disorders, and cardiopulmonary, hepatic, or renal insufficiency.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: HSP patients (ages 10 to 45) with foot deformities unresponsive to conservative therapy
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov