Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors

Обзор

The goal of this study is to: 1. Assess the usability of the SynPhNe device in a home environment. 2. Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.

Подробное описание

The goal of this study is to explore if the SynPhNe system can be used easily at home for people who suffered a stroke. With this study, we are also investigating if the SynPhNe system used could improve your hand function in comparison to conventional therapy.

SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly via Bluetooth with the computer to provide subject with feedback while performing motor tasks with their hand. The head cap records your brain activity and gives feedback to help relaxing while exercising.

The SynPhNe system has not been approved by the U.S. Food and Drug Administration.

Study participants will be randomized by chance (like a coin toss) to one of the two groups: lab-based upper extremity research therapy or the SynPhNe system for home-based exercises.

* The lab-based upper-extremity research therapy in its content is similar to regular occupational therapy and will focus exercise movements of arm and hand. * The group testing the SynPhNe system at home will have the system lent at no cost.

The study lasts for up to 12 weeks and involves up to 22 sessions in total:

* Up to 3 sessions will be for testing arm movements (at baseline, after research therapy and at 1 month follow-up). * 18 research therapy sessions. 10 of them will be done at Spaulding Rehabilitation Hospital with a therapist and 8 of them by yourself, at home. Study participants will either be using the SynPhNe system or the therapy plan recommended by the therapist, depending on the randomization. Each of these visits will be an hour long. They will be scheduled 3 days per week for six weeks.

Вмешательства

• Устройство SynPhNe platform
  SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly with the computer to provide feedback while performing motor tasks with the hemiparetic hand. The head cap records brain activity and gives feedback to help relaxing while exercising. The arm and the head component communicate wirelessly with the computer via Bluetooth. The head component reads brain signals while the arm gear senses your muscle signals when performin
• Другое Conventional therapy
  Exercise program established with a therapist (8 sessions under therapist direct supervision and 10 sessions at home). Low functioning subjects will be given more proximal joint-muscle exercises and activities while higher functioning subjects will have a greater component of distal tasks and activities. The therapist will review the exercises therapy plan with the subject and re-adjust it.

Первичные конечные точки

• Fugl-Meyer Upper Extremity - Motor [Срок оценки: Week 0, Week 7, Week 11]
• Box and Block Test [Срок оценки: Week 0, Week 7, Week 11]
• Wolf Motor Function Test - Functional Ablility [Срок оценки: Week 0, Week 7, Week 11]
• Wolf Motor Function Test - Performance Time [Срок оценки: Week 0, Week 7, Week 11]

Вторичные конечные точки (6)

• Grip Strength [Срок оценки: Week 0, Week 7, Week 11]
• Visual Analogue Scale for Pain [Срок оценки: Week 0, Week 7, Week 11]
• Spasticity -- Modified Ashworth Scale [Срок оценки: Week 0, Week 7, Week 11]
• Motor Activity Log - Amount of Use [Срок оценки: Week 0, Week 7, Week 11]
• EQ5D Questionnaire [Срок оценки: Week 0, Week 7, Week 11]
• Motor Activity Log - Quality of Movement [Срок оценки: Week 0, Week 7, Week 11]

Критерии участия

Критерии включения

• Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;
• Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;
• Ability to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow.

Критерии исключения

• Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;
• Current participation in upper-extremity therapy program;
• Treatment with Botox injections in the affected arm in the previous 3 months and no planned Botox injections before the end of the study;
• Aphasia sufficient to limit comprehension and completion of the treatment protocol;
• No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
• Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
• Previous diagnosis of dementia;
• Previous diagnosis of neurological diseases other than Stroke;
• History of seizures disorder and/or a seizure occuring within the last 6 months;
• Other conditions affecting function of the stroke affected upper limb;
• Severe pain in the stroke affected upper limb;
• Terminal diseases with expected survival <1 year;

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

США · 1 центр

• Spaulding Rehabilitation Hospital — Boston

Идентификаторы

NCT: NCT02896348 · 2016-P-000666

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗