Clinical trial NCT01887756: Research Online Tele-Rehabilitation Program in People After a Stroke Living at Home
Official title: Research and Clinical Aspects of the Project Study of Home Based Tele-Rehabilitation Program for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: telerehabilitation stroke virtual reatlity
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Telerehabilitation refers to the use of Information and Communication Technologies (ICT) to provide rehabilitation services to people remotely in their homes or other environments. By using ICT, patient access to care can be improved and the reach of clinicians can extend beyond the physical walls of a traditional healthcare facility, thus expanding continuity of care to persons with disabling conditions. The concept of telecare, when telerehabilitation is used to deliver services to patients in their homes or other living environments, empowers and enables individuals to take control of the management of their medical needs and interventions by enabling personalized care, choice and personal control Research Goal and Objectives

1. To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab system in post-stroke patients, in their homes.
2. To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's home in terms of:

   1. function of the weak upper extremity
   2. performance of ADL


Eligibility criteria: Inclusion Criteria:

* 6-72 months post stroke
* Sitting balance intact (ability to go beyond the midline of the body)
* Moderate impairment of the affected upper extremity determined by range of motion (ROM); shoulder flexion and abduction must be more than 45 degrees with mild to moderate compensations; elbow flexion should be about 45 degrees and trunk movement of about 10 cm.
* Basic ability to independently use the tele-system via touching virtual objects on the screen.
* Having a personal computer (at least Intel i3 processor, with Win7 operating system),Internet access (10MBps) and a large computer monitor (at least 26") at home.
* Caregiver, available when needed, toprovide support throughout the intervention.

Exclusion Criteria:

* Other medical conditions limiting participation in low-intensity exercise training.
* Major receptive aphasia and screening criteria consistent with dementia (Mini-MentalState score \<24).
* Untreated major depression.
* Presence of unilateral spatial neglect as determined by star cancellation (score less than 51).
* Hemianopsia
* Apraxia (limb and ideomotor)
* Other medical conditions that affect the central or peripheral nervous system
* Ataxia

Primary outcomes:
measure: System usability scale
timeFrame: Second assessment (after 6 weeks)
measure: Short Feedback Questionnaire
timeFrame: Second assessment ( after 6 week)
measure: Fugl-Meyer Assessment upper extremity part (FMA)
timeFrame: First assessment (beginning)
measure: Motor Activity Log
timeFrame: First assessment (beginning)
measure: Change in System Usability Scale between 6th week and 12th week
timeFrame: Third assessment (after 12 weeks)
measure: Change in Short Feedback Questionnaire between 6th week and 12th week
timeFrame: Third assessment (after 12 weeks)
measure: Change in Fugl-Meyer Assessment upper extremity part (FMA)between baseline and 6th week
timeFrame: Second assessment (after 6 weeks)
measure: Change in Fugl-Meyer Assessment upper extremity part (FMA)between 6th week and 12th week
timeFrame: Third Assessment (after 12 weeks)
measure: Change in Motor Activity Log between baseline and 6th week
timeFrame: Second assessment (after 6 weeks)
measure: Change in Motor Activity Log between 6th week and 12th week
timeFrame: Third assessment (after 12 weeks)
Secondary outcomes:
measure: Range of Motion (ROM) of shoulder and elbow
timeFrame: First, second and third assessments (beginning, 6 & 12 weeks respectively)
measure: Visual Analog Scale (VAS)
timeFrame: Second and third assessments (6 & 12 weeks respectively)
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: First and third assessments (beginning & 12 weeks respectively)
measure: Functional Independence Measure (FIM)
timeFrame: First and third assessments (beginning & 12 weeks respectively)
measure: Stroke Impact Scale (SIS)
timeFrame: First and third assessments (beginning & 12 weeks respectively)
Other outcomes:
measure: NIHSS
timeFrame: Beginning
measure: Behavioral Assessment of the Dysexecutive Syndrome (BADS)
timeFrame: Beginning
Locations:
city: Bat Yam
country: Israel
facility: Neurology Department, Bat Yamon Medical Center
Study officials:
affiliation: Clalit Health Services
name: Shlomo Flechter, MD
role: PRINCIPAL_INVESTIGATOR
References: