Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveil… (NCT06781658) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveillance
Ireland24 participantsStarted 2025-01-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of mild stable DCM
Timeframe: Baseline
2
Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria
Timeframe: Baseline
3
Participant recruitment rate
Timeframe: Baseline
4
Participant adherence to the intervention
Timeframe: 12 weeks
5
Clinician adherence to the intervention
Timeframe: 12 weeks
6
Acceptability of the intervention to the participants and clinicians