A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP

NCT06936163 | Recruiting

• 1 other identifier: 2025-KY-034(K)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.the long-term efficacy of foot deformity correction procedures;
2. 2.the optimal timing for surgical intervention;
3. 3.the establishment of objective evaluation criteria to guide therapeutic decision-making.

Conditions

Hereditary Spastic Paraplegia

Keywords

Hereditary Spastic Paraplegia; foot deformities

Outcome Measures

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.

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

Secondary Outcomes (5)

• Visual Analog Scale (VAS) Score

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

• Foot Posture Index (FPI)

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

• 6-Minute Walk Test (6MWT)

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

• Spastic Paraplegia Rating Scale (SPRS)

  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

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

Other Outcomes (2)

• MoCA score

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

• MMSE score

  From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.

Study Arms (1)

HSP patients (ages 10 to 45) with foot deformities unresponsive to conservative therapy

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.

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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 .
• Suboptimal response to standard conservative treatments (pharmacotherapy and/or rehabilitative exercise programs) with progressive worsening of gait abnormalities and foot deformities .
• Functional impairment secondary to isolated Achilles tendon contracture or equinovarus cavus deformity, manifesting as ambulatory pain, frequent falls, and significant quality-of-life limitations.
• Ability to ambulate barefoot for 10 meters independently or with assistive devices.

You may not qualify if:

• 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.
• Coexisting neurodegenerative or neuromuscular disorders that are unrelated to hereditary spastic paraplegia (HSP).
• Poor compliance with study requirements or other contraindications to participation in clinical trials.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 213000, China

RECRUITING

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary; Foot Deformities

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases

Study Officials

• Li Cao, phD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Cao, phD

CONTACT

+86 21 64369263; caoli2000@yeah.net

Wo tu Tian, phD

CONTACT

+86 21 64369181; wotu_tian@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)