Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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. 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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Li Cao, phD
caoli2000@yeah.net
+86 21 64369263
Backup
Wo tu Tian, phD
wotu_tian@163.com
+86 21 64369181
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: Shanghai 6th People's Hospital

This content was sourced from clinicaltrials.gov