跳至主要内容
临床试验/NCT04413240
NCT04413240Unknown不适用

Clinical Efficacy and Cost-effectiveness of Telerehabilitation for Post-stroke Patients

Universita di Verona2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Changes at the Aachener Aphasia Test score between the time frame

研究概览

简要总结

In the last few years, there has been an increasing shift towards outpatients setting in the care of patients with stroke. Unfortunately, this led to a high percentage of discharged patients who did not receive an adequate amount of rehabilitation, because of some non-clinical factors, such as resource availability, geographical location, age, and personal wealth. To date, there is growing evidence about the role of telerehabilitation as an effective method to deliver rehabilitative treatments to homebound subjects with no moving of therapists or patients. However, the most appropriate organizational models regarding Health Technology Assessment in telerehabilitation procedures still object of debate. On these bases, the aim of this project is to investigate the feasibility and effectiveness of multi-domains telerehabilitation procedures in stroke patients in order to supply the National Health Service with some useful information about the use of telerehabilitation in clinical practice of stroke rehabilitation.

详细描述

In the last few years, due to limited resources, stroke patients hospitalization has been progressively shortened with the increasing shift of some rehabilitation procedures towards outpatient settings. This led to a high percentage of discharged patients who doesn't receive an adequate amount of rehabilitation. This was because of some non-clinical factors, such as resources availability, geographical location, age and personal wealth. Unfortunately, the benefits gained during inpatient rehabilitation are often not sustained in the long term. Thus stroke patients progressively decrease their activity level leading to functional deterioration. To face these difficulties, telerehabilitation may be useful to deliver rehabilitative treatments to homebound subjects with no moving of therapists or patients. To date some studies highlighted that rehabilitation delivered from-distance has similar results of face-to-face one, confirming that telerehabilitation may be effectively used to address the growing call for improving home care. Despite these observations, telerehabilitation is still few integrated into outpatients territorial rehabilitative practice. Furthermore, the current literature about telerehabilitation is mainly focused on a single domain of intervention (i.e. motor, cognitive, speech), with scant data about the impact of telerehabilitation on global disability. Finally, the cost-benefit ratio of telerehabilitation, compared to usual territorial rehabilitation or prolonged hospitalization, still objects of debate.

Preliminary Data:

Previous literature about telerehabilitation evidenced an improved upper limb motor function with positive interaction stroke patient-therapist. A previous RCT evidenced similar recovery of motor performances in stroke patients who received telerehabilitation compared to "face to face" treatment. Moreover, was highlighted that patients treated with telerehabilitation were able to have good management of the system and a good relationship with therapists. Recently was showed feasibility and effectiveness of speech telerehabilitation, applied to lexical deficits in chronic stroke patients as well as of cognitive telerehabilitation in people with mild cognitive impairment, with results similar to "face-to-face" treatment.

In a systematic review on motor telerehabilitation, was supported the equivalence of "face to face" and "from a distance" delivery of neuromotor rehabilitation, showing no difference as to the effect of telerehabilitation compared to other rehabilitative interventions in neurological diseases. Furthermore, within the framework of an EU FP7 project focused on Integrated Home Care, was performed a review on home care in stroke patients, evidencing relevant suggestions to plan telerehabilitation trials, in order to observe the expected effectiveness from a multi-domains point of view in clinical, financial and social perspectives.

A multi-domain Health Technology Assessment approach was set up by the Istituto Superiore di Sanità (ISS), validated and implemented within the EU Project CLEAR. The model, a specialization of EUnet Health Technology Assessment model to telerehabilitation services, was applied to a 960-patients Pilot study in 4 EU Countries to address remote rehabilitation and management of several chronic neurological and motor diseases and was found appropriate for the purpose. The above ISS Health Technology Assessment model proved to have the potential to investigate telerehabilitation services in agreement with the Italian Guidelines on Telemedicine. Highly relevant, it allows exceeding the boundaries and limitations of a specific Hospital-based Health Technology Assessment, thus reaching the more general level of a national-based Health Technology Assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • first diagnosis of ischemic brain stroke documented radiologically by brain CT or MRI;
  • aphasia documented at the Aachener Aphasia Test (AAT) and/or presence of cognitive deficits documented at the neuropsychological assessment with the Oxford Cognitive Screen (OCS).
  • availability of ADSL or higher internet connection at home
  • ability of the subject and/or caregiver to understand and use the telerehabilitation system
  • signature of informed consent

排除标准

  • contemporary participation in other clinical studies;
  • cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score <26;
  • bone deformities as a consequence of previous traumatic events in the 4 limbs;
  • contractures fixed to the 4 limbs assessed as 4/4 on the modified Ashworth scale (MAS);
  • other neurological and orthopaedic diseases interfering with the study.
  • Particularly vulnerable populations. The following cannot be included in the study:
  • patients with judicial interdiction
  • patients with supportive administration
  • institutionalized patients
  • Criteria for the ongoing exit from the study
  • Relapse of disease during the study period
  • Withdrawal of informed consent to participate in the study
  • Impossibility to carry out the rehabilitation treatment or the assessments required by the study protocol according to the defined schedule.

结局指标

主要结局

Changes at the Aachener Aphasia Test score between the time frame

时间窗: T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

The Aachener Aphasia Test for the evaluation of aphasia is composed of 6 sections: spontaneous language, token test, repetition, written language (reading aloud, dictated by composition and dictated by handwriting), denomination (sentences, words, complex words) and oral and written comprehension. All items in the subtests repetition, written language, naming and comprehension are scored on a four-point scale, where 3 represents normal performance and 0 no response, preservation, automatism, or totally unrelated to the target.

Changes at the Oxford Cognitive Screen score between the time frame

时间窗: T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

The Oxford Cognitive Screen is a short and efficient cognitive screening tool that can be delivered at the bedside in acute stroke. OCS is easy to administer and score and importantly is inclusive for patients with aphasia and neglect. OCS returns a single, not divisible visual snapshot of a patient's cognitive profile, which at a glance demonstrates the specific cognitive domain impairments in Attention, Language, Praxis, Number and Memory.

Changes at the Fugl-Meyer Assessment score between the time frame

时间窗: T0 (baseline) - T1 (4 weeks) - T2 (8 weeks)

The Fugl-Meyer Assessment allows quantifying the degree of post-stroke disability through the evaluation of the following 5 domains of interest. In the upper and lower limbs: the motor function; sensory function; the range of motion; joint pain. The last domain is balance control. The maximum possible score in the Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery.

次要结局

  • Barthel Index (BI)(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))
  • Beck Depression Inventory scale (BDI-scale)(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))
  • Short-Form-36 (SF-36)(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))
  • Perceived Disease Impact Scale (PDIS)(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))
  • Caregiver Burden Inventory(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))
  • Hospital Readmission Rate(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))
  • Client Satisfaction Questionnaire(T0 (baseline) - T1 (4 weeks) - T2 (8 weeks))

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Smania, MD, Clinical Professor

Chief of the Neurorehabilitation Unit. Full Professor.

Universita di Verona

研究点 (2)

Loading locations...

相似试验