Hereditary Spastic ParaplegiaHSPNCT06936163
A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
An observational study of Hereditary Spastic Paraplegia, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 45 years
- Conditions the study is for
- Hereditary Spastic Paraplegia
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Apr 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 213000
Wo tu Tian, phD, 02164369181, wotu_tian@163.com
About this study
Official title: Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study
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:
- the long-term efficacy of foot deformity correction procedures;
- the optimal timing for surgical intervention;
- the establishment of objective evaluation criteria to guide therapeutic decision-making.
Read the detailed description
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.
- Conditions
- Hereditary Spastic Paraplegia
- Keywords
- Hereditary Spastic Paraplegia, foot deformities
- Medical subject headings
- Spastic Paraplegia, Hereditary, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Spastic ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Cao, Shanghai 6th People's Hospital
- Investigators
- Li Cao, phD, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936163
- Sponsor's protocol ID
- 2025-KY-034(K)
- Acronym
- HSP
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes of Foot Deformities in Hereditary Spastic Paraplegia: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06936163
- Acronym / sponsor ID
- HSP / 2025-KY-034(K)
- Conditions
- Hereditary Spastic Paraplegia
- Keywords
- Hereditary Spastic Paraplegia, foot deformities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the long-term efficacy of foot deformity correction procedures;
- the optimal timing for surgical intervention;
- the establishment of objective evaluation criteria to guide therapeutic decision-making.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
American Orthopaedic Foot and Ankle Society Score（AOFAS scores）
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.
5 secondary outcomes
Visual Analog Scale (VAS) Score
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Foot Posture Index (FPI)
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
6-Minute Walk Test (6MWT)
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Spastic Paraplegia Rating Scale (SPRS)
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
Time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Cao, phD principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Spastic Paraplegia, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Cao, phD (+86 21 64369263, caoli2000@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopaedic Foot and Ankle Society Score（AOFAS scores） (time frame: From the end of treatment to observations at 1 months, 3months, 6months, 12months, 18months, and 24months respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.