NIPH Clinical Trials Search

A clinical study on the efficacy of exercise therapy using a robot control system and a lumbar-type hybrid assistive limb for patients with cervical spondylotic myelopathy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Cervical spondylotic myelopathy
Date of first enrollment	02/03/2026
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	This study will conduct a comparative, parallel-group study involving three groups. The groups are as follows: - Exercise therapy group using both the LOCOBOT and HAL waist type (LOCOBOT + HAL) - Exercise therapy group using only the HAL waist type (HAL) - Exercise therapy group using no devices (control) All patients will receive one-on-one rehabilitation from a physical therapist who specializes in musculoskeletal disorders for 40 minutes, once daily, during their hospitalization following CLP. Within the 40-minute rehabilitation session, 15 minutes will be dedicated to each of the following: exercise therapy using both the LOCOBOT and the HAL waist type, exercise therapy using only the HAL waist type, and exercise therapy without devices.

Outcome(s)

Primary Outcome

Change from baseline (pre-CLP implementation) after 21 days: Comparison of three groups Unit area trajectory length in the centre of gravity sway test (open- and closed-eye standing).

Secondary Outcome

1) Change from baseline after 21 days: Comparison of three groups (1) Total excursion, mean velocity of the center ofpressure (CoP), area of CoP sway, area of a rectangle, and Romberg ratio (open- and closed-eye standing). (2) Changes in foot pressure distribution duringopen- and closed-eye standing. (3) Changes in total spinal sagittal alignment. C2-7 lordosis (CL) C2-7 sagittal vertical axis (SVA) T1 slope (T1S) Sagittal vertical axis (SVA) Lumbar lordosis (LL) Pelvic tilt (PT) Sacral slope (SS) (4) Change in the total Japanese Orthopedic Association (JOA) cervical spinal cord syndrome treatment outcome criteria score. (5) Change in the 3-meter Timed Up and Go (3mTUG) test. (6) Change in the functional reach test. (7) Change in the Berg Balance Scale (BBS). 2) Changes in operation time, unit area, trajectorylength, total excursion, mean velocity of the CoP,and area of CoP sway and a rectangle during LOCOBOT operation (LOCOBOT group only). Measurements are taken on days 7,14, and 21 after CLP implementation.

Key inclusion & exclusion criteria

Age minimum	>= 40age old
Age maximum	< 100age old
Gender	Both
Include criteria	1) Individuals aged 40 or older, but under 100, at the time of consent acquisition. 2) Individuals diagnosed with cervical spondylotic myelopathy (CSM) who underwent cervical laminoplasty (CLP). 3) Individuals with a walking impairment category of 1.5 or lower (Capable of unassisted walking on level surfaces, though gait is unstable), according to the Japanese Orthopedic Association (JOA) score for assessing treatment outcomes of cervical spondylosis. 4) Individuals from whom written consent was obtained of their own free will.
Exclude criteria	1) Individuals who underwent CLP for conditions other than CSM, such as ossification of the posterior longitudinal ligament, cervical disc herniation, spinal canal stenosis, or spinal cord tumors. 2) Individuals with balance disorders not attributable to CSM (e.g., vestibular dysfunction). 3) Individuals deemed ineligible for inclusion in the study by the study coordinator.