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Clinical Trials in Ireland / NCT06781658
Starting soon Not applicable

Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveillance

NCT06781658 · tracked via the Priya Life Science Ireland tracker
Sponsor
Royal College of Surgeons, Ireland
Phase
Not applicable
Started
2025-01-13
Last updated
2025-01-17

Condition(s) studied

Degenerative Cervical Myelopathy

Investigational drug(s) / intervention(s)

Structured rehabilitation interventionClinical Surveillance

Structured rehabilitation intervention: Participants will be prescribed a multi-component SRI which will include education, cervical range of motion exercises, progressive neck strengthening exercises, individualised scapular and upper limb strengthening, task specific hand function training and a physical activity behavioural change intervention. The TIDieR checklist has been used to provide a comprehensive description of this complex intervention. (17).

Clinical Surveillance: Participants assigned to the clinical surveillance control group will be invited to attend a single, one to one education session which will be supplemented with a written patient information booklet after which they will be scheduled for a 12 week follow up.

Study summary

The goal of this feasibility RCT is to establish the feasibility of undertaking a RCT investigating the effectiveness of a multi component structured rehabilitation intervention aiming at reducing physical disability in people with mild stable Degenerative Cervical Myelopathy. The main question it will answer are what is the incidence of mild stable DCM in the neurosurgical OPD clinics, what is the eligibility rate and participate rate of those eligible. It will also investigate the acceptability of the intervention to both participants and clinicians and participant retention.

Researchers will compare a structured rehabilitation intervention to clinical surveillance. The structured rehabilitation intervention will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * • Diagnosis of DCM (Clinical symptom of DCM +/- Upper motor neuron sign + imaging evidence of cervical cord compression). Diagnosis will be confirmed by a consultant neurosurgeon (19). * Modified Japanese Orthopaedic assessment (mJOA) score of 15-17, indicating mild DCM. The mJOA is a clinician administered validated measure of DCM severity (20) * Adequate comprehension of English to understand the purpose of the study and give written informed consent Exclusion Criteria: * Patient or surgeon preference for urgent surgical decompression for progressive DCM, motor radiculopathy or severe unrelenting radicular arm pain or significant risk factors for progression including co-existing cervical radiculopathy and circumferential cord compression. * Diagnosis of other neurological condition that could confound assessment. * Involvement in another clinical study or trial * Pregnancy * If the participant is unable to commit to a 12-week programme of up to 10 sessions of supervised rehabilitation and participating in a regular home exercise programme for the duration of the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beaumont Hospital Dublin Ireland

More Royal College of Surgeons, Ireland trials in Ireland

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781658 on ClinicalTrials.gov ↗ ← All trials in Ireland