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Идёт набор NCT05615766

Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

Без фазы С лечением Spinal Cord Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Experimental: Device Intervention.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients

Обзор

Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life. The objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total. Patients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage. We shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function.

Вмешательства

  • Устройство Experimental: Device Intervention
    The robotic rehabilitation programme using the MARK from Myomo (myomo.com) for the intervention group will last for 12 weeks with up to four sessions of rehabilitation per week, i.e. total of 48 sessions. Spinal cord injured inpatients in the study will have this intervention on their dominant arm in addition to the traditional rehabilitation programme assigned and standard care.

Первичные конечные точки

  • Spinal Cord Independence Measure version III (SCIM III) [Срок оценки: Change from baseline (week 1) at 6 weeks]
  • Spinal Cord Independence Measure version III (SCIM III) [Срок оценки: Change from baseline (week 1) at 12 weeks]
Вторичные конечные точки (4)
  • The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP). [Срок оценки: Change from baseline (week 1) at 6 weeks and 12 weeks]
  • The modified Ashworth scale [Срок оценки: Change from baseline (week 1) at 6 weeks and 12 weeks]
  • Range of Motion [Срок оценки: Change from baseline (week 1) at 6 weeks and 12 weeks]
  • Canadian Occupational Performance Measure (COPM) [Срок оценки: Change from baseline (week 1) at 6 weeks and 12 weeks]

Критерии участия

Критерии включения

  • Age 18+ years.
  • The levels of C5 C6 Asia C/D would provide individuals with elbow and hand impairment and potentially functional shoulder movements. C7, C8 individuals could also benefit from the hand component of the device.
  • Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest potential for functional change.
  • Preservation of hand sensation as base for motor restoration.
  • Some sitting balance would give the best opportunity for the arm to be released for functional upper limb activity.
  • EMG (muscle activity) evidence of active finger flexion, extension and elbow flexion extension Grade 1-2.
  • Minimal or No community functional use of upper limb at start of trial.
  • Spasticity MAS 1-3/5.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Простое слепое
Основная цель
Оценка устройства

Центры проведения

Великобритания · 2 центра
  • Royal National Orthopaedic Hospital (Stanmore) — London
  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry

Идентификаторы

NCT: NCT05615766 · IRAS312522

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗