Efficacy and Safety of Cervicothoracic Orthosis for Patients with Neck Drop Syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042250019

Enrollment

Registered

2025-04-30

Start date

2025-05-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

drooping neck syndrome

Interventions

A cervicothoracic orthosis developed for patients with drop neck syndrome will be worn for 27 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older, regardless of gender 2. patients with a diagnosis of neck drop syndrome, with an apparent neck drop and forward gaze disorder 3. patients who are undergoing treatment for the neck drop syndrome. 4. patients who have consented to participate in this study by signing a consent form in person.

Exclusion criteria

Exclusion criteria: 1. those with stubborn neck pain and symptoms of spinal nerves such as numbness and paralysis in the extremities 2. patients with neuromuscular diseases such as myopathy, Parkinson's disease, myasthenia gravis, amyotrophic lateral sclerosis, multiple system atrophy, or endocrine diseases such as hypothyroidism or rickets, which cause neck drop syndrome, and those with a tendency toward deterioration 3. those who are allergic to the material of the brace 4. those who have communication difficulties in responding to the questionnaires 5. Any other person whom the principal investigator or a subinvestigator determines is not appropriate to be included in this study.

Design outcomes

Primary

Measure	Time frame
Changes in Quality of Life Summary Scores for Physical Aspects of the SF-36 (Japanese version)	—

Secondary

Measure	Time frame
1) Questionnaire (EQ-5D-5L (Japanese version), JOACMEQ (Japan Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire), SF-36 mental and role/social aspects of QOL summary score changes) 2) X-ray parameters ((pelvic incidence (PI), pelvic tilt (PT), lumbar lordosis (LL), PI-LL, T5-T12 sagittal cobb angle, T1 slope(TS), sagittal vertical axis ( SVA), C2-C7 sagittal cobb angle(CL), TS-CL, cervical sagittal vertical axis (C2SVA)) 3) Changes in gait parameters (stride length, gait speed, step distance, coronal plane trunk tilt angle, anterior trunk tilt angle) 4) Adverse events 5) Satisfaction Rating	—

Measure

Time frame

1) Questionnaire (EQ-5D-5L (Japanese version), JOACMEQ (Japan Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire), SF-36 mental and role/social aspects of QOL summary score changes) 2) X-ray parameters ((pelvic incidence (PI), pelvic tilt (PT), lumbar lordosis (LL), PI-LL, T5-T12 sagittal cobb angle, T1 slope(TS), sagittal vertical axis ( SVA), C2-C7 sagittal cobb angle(CL), TS-CL, cervical sagittal vertical axis (C2SVA)) 3) Changes in gait parameters (stride length, gait speed, step distance, coronal plane trunk tilt angle, anterior trunk tilt angle) 4) Adverse events 5) Satisfaction Rating

—

Contacts

Public ContactHideyuki Arima

Hamamatsu University School of Medicine

arima@hama-med.ac.jp+81-53-435-2299

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026