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

Rehab in Mild DCM: Study Protocol for a Feasibility Randomised Controlled Trial to Compare the Effectiveness of a Structured Rehabilitation Intervention to Clinical Surveillance in People With Mild Stable Degenerative Cervical Myelopathy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Cervical Myelopathy
• Intervention / Treatment: Other: Structured rehabilitation intervention; Other: Clinical Surveillance

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Treanor, Bsc Msc; Phone Number: 2536 01 809 3000; Email: carolinetreanor22@rcsi.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Beaumont Hospital
    • Contact: Caroline Treanor, Bsc MSC; Phone Number: 2536 018093000; Email: carolinetreanor@beaumont.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of mild stable DCM	Number of people with mild stable DCM during the study period/ number of NP seen.	Baseline
Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria	The number of people with mild stable DCM over the study period- the number of people with mild stable DCM who are eligible to participate in the study.	Baseline
Participant recruitment rate	The number of participants recruited per month	Baseline
Participant adherence to the intervention	The number of scheduled sessions attended by the participants.	12 weeks
Clinician adherence to the intervention	The number of core intervention components included in each treatment session	12 weeks
Acceptability of the intervention to the participants and clinicians	Semi-structured interviews	12 weeks
Burden of measurement tool completion	Semi structured interview	12 weeks
Participant retention rate	Loss to follow up rate and reasons for loss to follow up	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical component score of the short form (SF) 36	Physical functioning	Baseline and 12 weeks
Modified Japanese Orthopaedic association index (mJOA)	Myelopathy severity scale	Baseline and 12 weeks
Neck disability index	Neck pain related disability	Baseline and 12 weeks
Spinal adverse events severity scale	Adverse events	12 weeks

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Ciaran Bolger, MD PhD, Royal College of Surgeons

Study record dates

Study Major Dates

• Study Start (Estimated): January 13, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Degenerative cervical myelopathy; Feasibility RCT; Mild DCM; clinical Surveillance
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: 23-172

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No