Home Tele Rehabilitation Therapy for Vascular Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)
详细描述
This is a controlled evaluator masked parallel study of chronic (>6mo from stroke onset) ischemic or hemorrhagic stroke patients diagnosed with and without vascular dementia to test the feasibility and effect of remote rehabilitation therapy targeting the weaker arm compared to usual care. All patients will undergo baseline evaluation, then usual care for 1 month followed by a remote telerehabilitation treatment for one month, followed by an evaluation 1 month after the completion of treatment.
Research procedures:
Subject Recruitment/Screening: Participants will be recruited from the PI's stroke recovery specialty clinic, and the Houston Methodist Hospital system by flyers and educating clinicians about the proposed study and the patient requirements. Prospective participants may also be identified through mining electronic medical records for ICD-9 and ICD-10 codes for stroke and hemiparesis for potentially eligible participants. Participants that appear to meet eligibility criteria based on the phone screening and medical record review will be invited to participate in an in-person screening session to ensure that they met the full inclusion criteria prior to being enrolled in the study.
Throughout all study visits subjects will be monitored for safety, comfort and any adverse events by trained study staff.
Initial Evaluation/Dependent Measures: The subject's initial evaluation will include questionnaires and impairment and functional scales. We will record demographic information, brain imaging, stroke history and medical history and medications from electronic medical records. We will store the deidentified brain imaging in XNAT under a study identifier on the secure server available at HMH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Self-report measures will be not blinded, assessors will be blinded to treatment phase (SOC or telerehabilitation)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging
- •at least 6 months post stroke
- •At least some active movement in the affected upper extremity (MRS 1 or more in shoulder elbow or wrist)
- •Ability to provide informed consent, or LAR able to provide consent
- •Expressed willingness to comply with all study procedures and attend all study-related visits for both the patient and at least one caregiver.
- •Ability to follow one-step commands.
- •Community-dwelling with transportation to evaluation sessions.
- •Ability to operate the therapy system with minimal assistance, including sufficient corrected vision to perceive objects from a distance of 5 feet.
- •Modified Ashworth Scale Score 3 or less in the involved upper extremity
- •Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
排除标准
- •Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions even with help from caregiver).
- •Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- •Patients with severe uncontrolled medical problems that would render intensive rehabilitation unfeasible or unsafe (e.g. cardiovascular disease, unstable cardiac arrhythmia, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
- •Concurrent participation in other experimental upper extremity rehabilitation trials that would interfere with results.
- •Non-English-speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However, we plan to include them once funding has been secured in the subsequent larger trial.
- •Pregnancy
- •Prisoners
研究组 & 干预措施
Tele Rehabilitation
Telerehabilitation therapy Occupational therapist prescribed hand/arm exercises will continue for 90 minutes per day with adequate rest periods for 4 weeks, followed by telerehabilitation with the application for 4 weeks, when subjects will perform the tasks at home with the guidance of the treatment app. Detailed records of each subject's motor tasks, number of repetition and level of performance will be kept. Treatment will be performed Monday-Friday for approximately 4 weeks. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences.
干预措施: Home telerehabilitation therapy (Other)
结局指标
主要结局
Adverse events
时间窗: 3-4 months
Prospective record of adverse events including dropouts
Burden Scale for Family Caregivers
时间窗: 3-4 months
Burden Scale for Family Caregivers BSFC-s\[8\] Subjective caregiver burden 10-item short version of the questionnaire.
次要结局
- Wolf Motor Function Test (WMFT)(3-4 months)
- Fugl-Meyer Upper extremity assessment(3-4 months)
研究者
Timea Hodics
Principal Investigator
The Methodist Hospital Research Institute