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

NCT ID: NCT06781658

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Degenerative Cervical Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Structured rehabilitation intervention

The SRI 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.

Group Type: EXPERIMENTAL

Structured rehabilitation intervention

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Clinical Surveillance

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ciaran Bolger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

Central Contacts

Caroline Treanor, Bsc Msc

Role: CONTACT

carolinetreanor22@rcsi.ie

01 809 3000 ext. 2536

Facility Contacts

Caroline Treanor, Bsc MSC

Role: primary

carolinetreanor@beaumont.ie

018093000 ext. 2536

Other Identifiers

23-172

Identifier Type: -

Identifier Source: org_study_id