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

A randomized controlled trial evaluating the efficacy of exercise therapy combining a robot control system and a lumbar-type hybrid assistive limb for patients with cervical spondylotic myelopathy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072250137

Enrollment

Registered

2026-03-02

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical spondylotic myelopathy

Interventions

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) - Exer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Contacts

Public ContactShigeaki Miyazaki

Miyazaki University Hospital

03-5-23@med.miyazaki-u.ac.jp+81-985-85-1510

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026