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

Официальное название

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.

Обзор

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.

Вмешательства

• Другое 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).
• Другое 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.

Первичные конечные точки

• Incidence of mild stable DCM [Срок оценки: Baseline]
• Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria [Срок оценки: Baseline]
• Participant recruitment rate [Срок оценки: Baseline]
• Participant adherence to the intervention [Срок оценки: 12 weeks]
• Clinician adherence to the intervention [Срок оценки: 12 weeks]
• Acceptability of the intervention to the participants and clinicians [Срок оценки: 12 weeks]
• Burden of measurement tool completion [Срок оценки: 12 weeks]
• Participant retention rate [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

• Physical component score of the short form (SF) 36 [Срок оценки: Baseline and 12 weeks]
• Modified Japanese Orthopaedic association index (mJOA) [Срок оценки: Baseline and 12 weeks]
• Neck disability index [Срок оценки: Baseline and 12 weeks]
• Spinal adverse events severity scale [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Ирландия · 1 центр

• Beaumont Hospital — Dublin

Идентификаторы

NCT: NCT06781658 · 23-172

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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