Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

Официальное название

Cortical Priming to Optimize Gait Rehabilitation: Renewal

Обзор

Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.

Вмешательства

• Другое Transcranial direct current stimulation (tDCS)
  1 mA tDCS
• Другое Ankle motor training
  Visuomotor target tracking task
• Поведенческое High intensity interval speed based treadmill training (HIISTT)
  Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.

Первичные конечные точки

• Walking speed with 10 meter walk test [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up]

Вторичные конечные точки (12)

• Walking spatiotemporal characteristics with GAITRite walkway [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up]
• Motor impairment with Fugl Meyer Lower Extremity Scale [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up]
• Walking endurance with 6-minute walk test [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up]
• Ankle range of motion [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up]
• Ankle motor control [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up]
• Balance with mini Balance Evaluations Systems Test (miniBESTest) [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up.]
• Aerobic capacity [Срок оценки: Change from baseline to immediately after training.]
• Quality of Life with EuroQol-5D (EQ-5D) [Срок оценки: Change from baseline to immediately after training.]
• Disability with Modified Rankin Scale [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up.]
• Community ambulation with wearable sensors [Срок оценки: Change from baseline to immediately after training.]
• Serum brain derived neurotrophic growth factor (BDNF) [Срок оценки: Change from baseline to immediately after training.]
• Corticomotor excitability using transcranial magnetic stimulation [Срок оценки: Change from baseline to immediately after training and baseline to 3 months follow up.]

Критерии участия

Критерии включения

• Age greater than 18 years
• First ever monohemispheric stroke > 3 months since onset
• Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
• Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
• Walking speed lesser than 1.2 m/s
• Lower limb Fugl-Meyer Motor score between 15-30
• At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task

Критерии исключения

• General exclusion criteria

• Severe osteoporosis
• Contracture-limiting range of motion of lower limb
• Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
• Uncontrolled anti-spasticity medications during the study period
• Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
• Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
• Unhealed decubiti, persistent infection
• Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
• Lesions involving the brainstem and cerebellum
• Failure to pass the graded exercise stress test

TMS exclusion criteria

• Implanted cardiac pacemaker
• Metal implants in the head or face
• Unexplained, recurring headaches
• History of seizures or epilepsy
• Currently under medication that could increase motor excitability and lower seizure threshold
• Skull abnormalities or fractures
• Concussion within the last 6 months
• Currently pregnant

tDCS exclusion criteria

• Skin hypersensitivity
• History of contact dermatitits
• History of allodynia and/or hyperalgesia
• Any other skin or scalp condition that could be aggravated by tDCS

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Physical Therapy — Chicago

Публикации

• Cleland BT, Madhavan S. The Association of Interlimb Coordination and Temporal Symmetry With Walking Function and Motor Impairment After Stroke. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1104-1109. doi: 10.1097/PHM.0000000000002522. Epub 2024 May 6. PMID 38709654

Идентификаторы

NCT: NCT04477330 · 2020-0502

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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