A Prospective Cohort Study of ITB Treatment for HSP

Condition(s) studied

Study summary

The investigators conduct a prospective cohort study to explore the treatment effectiveness of continuous infusion of intrathecal baclofen (ITB) for hereditary spastic paraplegia (HSP) in China, delve into the optimal timing for starting treatment, and investigate the response differences among different subtypes. The ultimate goal is to provide clinical evidence and guidance for the application of ITB in treating HSP in China, as well as improve the life expectancy and quality of life for HSP patients. The main questions it aims to answer are:

1. Changes in gait and motor function, as well as spasticity levels, compared to pre-surgery and control group after ITB surgery.
2. Changes in quality of life, pain, psychological and emotional status, and cognition compared to pre-surgery and control group after ITB surgery.
3. Complications following ITB surgery.
4. Impact of ITB surgery on the occurrence and progression of skeletal deformities.
5. Subgroup analysis: comparing surgical outcomes between different genotypes and between simple versus complex types.
6. Determine the optimal timing for ITB intervention.

Eligibility

Primary outcome measure(s)

• Six-Minute Walk Test(6-MWT) — From the end of treatment to observations at 6 months, 12months, 18months, 24months, 30months, and 36months respectively
  The 6-MWT measures the distance a person can walk in six minutes. A shorter distance indicates lower exercise capacity.
• Step length — From the end of treatment to observations at 6 months, 12months, 18months, 24months, 30months, and 36months respectively
  Step length is measured by gait analysis device. Step length refers to the distance from the heel strike of one foot to the heel strike of the opposite foot. Longer step length indicates that the patient has improved lower limb muscle strength and coordination, and that spastic symptoms have been alleviated.
• walking speed — From the end of treatment to observations at 6 months, 12months, 18months, 24months, 30months, and 36months respectively
  Walking speed is measured by gait analysis device. Walking speed refers to the distance covered by a person within a unit of time while walking, expressed in meters per minute (m/min). An increase in walking speed indicates an improvement in spasticity and motor function.
• knee flexion angle — From the end of treatment to observations at 6 months, 12months, 18months, 24months, 30months, and 36months respectively
  Knee flexion angle is measured by gait analysis device.An increase in the knee flexion angle indicates improved motor function and reduced spasticity.
• Modified Ashworth Scale(MAS) — From the end of treatment to observations at 6 months, 12months, 18months, 24months, 30months, and 36months respectively
  range: 0-4, higher scores mean more severe spasticity.
• Range of Motion (ROM) of Joints — From the end of treatment to observations at 6 months, 12months, 18months, 24months, 30months, and 36months respectively
  ROM refers to the distance and direction a joint can move to its full potential. Flexion, extension, abduction, adduction of joints are measured.

Trial sites (1)

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