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

NCT06781658 | Not Yet Recruiting DMC

• 1 other identifier: 23-172
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Degenerative cervical myelopathy; Mild DCM; Rehabilitation; clinical Surveillance; Feasibility RCT

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Physical component score of the short form (SF) 36

  Baseline and 12 weeks

• Modified Japanese Orthopaedic association index (mJOA)

  Baseline and 12 weeks

• Neck disability index

  Baseline and 12 weeks

• Spinal adverse events severity scale

  12 weeks

Study Arms (2)

Structured rehabilitation intervention

EXPERIMENTAL

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

Clinical surveillance

ACTIVE COMPARATOR

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

Interventions

Structured rehabilitation intervention 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).

Structured rehabilitation intervention

Clinical Surveillance 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.

Clinical surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

Location

Study Officials

• Ciaran Bolger, MD PhD

  Royal College of Surgeons

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Treanor, Bsc Msc

CONTACT

01 809 3000; carolinetreanor22@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Every participant will have a unique identifier. The outcome assessors will be blinded to group allocation. Clinicians delivering the interventions and trial participants will not be blinded to group allocations due to the nature of the intervention (56). Participants will be asked in advance of attending for their 12 week follow up not to disclose their group allocation with the outcome assessor. Data analysts will be blinded to group allocation. Unblinding will only occur in exceptional circumstances when knowledge of the group allocation is essential for further management of the participant (57).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

IE (1)