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临床试验/NCT02615132
NCT02615132已完成不适用

TeleRehab for Patients With Post-Stroke Communication Deficits Using Mobile Technology

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Feasibilily (recruitment and adherence rates)

研究概览

简要总结

Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained a stroke. These deficits include difficulty to produce or understand language, motor speech disorders and cognitive-communication disorders. It is estimated that approximately 40% of stroke survivors will have communication disorders post stroke.

In this randomized controlled study, the investigators' objective is to test the value of providing a mobile platform-based Speech Language Therapy (SLT) program to patients discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab services versus standard of care treatment. The investigators will offer iPad-based SLT/standard of treatment to a convenience sample of 20 patients with post-stroke communication deficits. The primary outcome will be feasibility (recruitment rate, adherence rate, retention rate, and protocol deviations), and the secondary outcome will be improvement in PSCD.

详细描述

A. APPLICANT INFORMATION

Proposed Project Title TeleRehab for Patients with Post-Stroke Communication Deficits using Mobile Technology

Primary Investigator

Karen Mallet, M.H.Sc., M.Ed. SLP (C) Speech-Language Pathologist Champlain Regional Stroke Network and the Ottawa Hospital - Civic Campus 1053 Carling Avenue, Ottawa, ON K1Y 4E9

Co-PI: Dariush Dowlatshahi MD PhD FRCPC Assistant Professor, University of Ottawa Scientist, Ottawa Hospital Research Institute Ottawa Hospital Civic Campus C2182b 1053 Carling Ave, Ottawa, ON K1Y 4E9

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diagnosis of stroke being discharged from the Neurology unit and/or the Neurology Acute Care Unit in the Civic Campus of TOH.
  • Patients presenting with overall mild to moderate communication deficits, And/or
  • Patients with score ≥ 1 on the best language and/or dysarthria parameters of the National Institute of Health Stroke Score (NIHSS)
  • Stroke Patients being discharged to their HOME/PRIMARY RESIDENCE awaiting outpatient speech and language therapy services.
  • Patients being discharged to their HOME/PRIMARY RESIDENCE who would benefit from SLP therapy services but are unable to receive these secondary to various accessibility challenges (i.e. remote geographical location, limited service availability, transportation, unable to pay for SLP services).
  • Patients must have access to Wi-Fi connection at their HOME/PRIMARY RESIDENCE.

排除标准

  • 1. Patients with pre-existing speech, language disorders or cognitive disorders (such as dementia).
  • 2. Patients with severe debilitating disease(s) that, in the opinion, of the investigator will not be able to perform the required tasks of the study (ex: end-stage malignancy, ALS).
  • 3. Patients with severe comprehension deficits
  • Patients not having access to Wi-Fi connection at HOME/PRIMARY RESIDENCE.
  • Patients who will be accessing the services of a private SLP while awaiting outpatient rehab.

研究组 & 干预措施

Treatment Group

Experimental

The study SLP will instruct the patient to use the ipad apps as intervention for at least one-hour per day, until they are admitted to outpatient SLP services or for a maximum of 8 weeks, whichever comes first. Throughout the telemedicine treatment phase, patients' progress will be monitored remotely by a study SLP through Apps/Skype/Facetime/Telephone consultation on a weekly basis.

干预措施: iPad (Behavioral)

Control

No Intervention

Patients will be sent home with standard of care.

结局指标

主要结局

Feasibilily (recruitment and adherence rates)

时间窗: 18 months

The investigators will assess the primary outcome of feasibility by determining: 1. Total number of patients enrolled: This is the numerical total of all pateints enrolled in the study. 2-Recruitment rate : this is the number of patients enrolled divided by the total number of patients admitted with stroke within the same time period. 3- Proportional benefit:The investigators will also estimate the proportion of the discharged PSCD population that can benefit from this intervention. 4. Adherence rate = the total number of patients who completed the full course of intervention divided by the total number of patients enrolled. This measure will determine whether discharged PSCD patients can actually tolerate and complete the therapy.

Recruitment

时间窗: 13 months

The investigators will assess the primary outcome of recruitment by determining: Total number of patients enrolled. This is the numerical total of all patients enrolled in the study

次要结局

  • Secondary outcome (Potential improvement)(18 months)
  • Retention Rate(8 week follow up)
  • Adherence Rate(8 week follow up)
  • Percentage of Patients Being Engaged in Study(8 week follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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