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Not yet recruiting NCT06781658

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

No phase Interventional Degenerative Cervical Myelopathy

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structured rehabilitation intervention, Clinical Surveillance.
Who it may be relevant to
Registry conditions: Degenerative Cervical Myelopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Interventions

  • 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).
  • 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.

Primary outcome measures

  • Incidence of mild stable DCM [Time frame: Baseline]
  • Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria [Time frame: Baseline]
  • Participant recruitment rate [Time frame: Baseline]
  • Participant adherence to the intervention [Time frame: 12 weeks]
  • Clinician adherence to the intervention [Time frame: 12 weeks]
  • Acceptability of the intervention to the participants and clinicians [Time frame: 12 weeks]
  • Burden of measurement tool completion [Time frame: 12 weeks]
  • Participant retention rate [Time frame: 12 weeks]
Secondary outcome measures (4)
  • Physical component score of the short form (SF) 36 [Time frame: Baseline and 12 weeks]
  • Modified Japanese Orthopaedic association index (mJOA) [Time frame: Baseline and 12 weeks]
  • Neck disability index [Time frame: Baseline and 12 weeks]
  • Spinal adverse events severity scale [Time frame: 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Ireland · 1 center
  • Beaumont Hospital — Dublin

Identifiers

NCT: NCT06781658 · 23-172

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗