Research Online Tele-Rehabilitation Program in People After a Stroke Living at Home

NCT01887756 | Terminated

• 1 other identifier: GTR-Motion
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

telerehabilitation stroke virtual reatlity

Outcome Measures

Primary Outcomes (10)

• System usability scale

  This questionnaire includes 10 items which provide a global view of subjective assessment of a system's usability. Each item was rated on a five-point scale from one (disagree totally) to five (agree totally). Five items are positive statements, such as "I think that I would like to use this system frequently" and "I thought the system was easy to use" and the other five items are negative, for example, "I found the system unnecessarily complex" and "I think that I would need the support of a technical person to be able to use this system." The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown by the authors to be a robust and reliable evaluation tool but its psychometric properties have not been fully investigated. (Brooke et al., 1995)

  Second assessment (after 6 weeks)

• Short Feedback Questionnaire

  This is an 8-item questionnaire which queries the user's sense of presence, perceived difficulty of the task and any discomfort that users may have felt during the experience. The first six items assess the participant's (1) feeling of enjoyment, (2) sense of being in the environment, (3) success, (4) control, (5) perception of the environment as being realistic and (6) whether the feedback from the computer was understandable. The seventh item queries whether participants felt any discomfort during the experience. An eighth item queries their perceived difficulty while performing the task. Responses to the first seven items are rated on a scale of 1-5 where 1=not at all and 5 = very much. Responses to the eighth item is also rated on a 1-5 scale where 1= very easy and 5= very difficult. A total mean score for each participant will be calculated for the first six items.(Kizony et al., 2006)

  Second assessment ( after 6 week)

• Fugl-Meyer Assessment upper extremity part (FMA)

  The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established (Fugl-Meyer et al., 1975; Wood-Dauphinee, Williams, \& Shapiro, 1990; Chae, Johnston, Kim, \&Zorowitz, 1995).

  First assessment (beginning)

• Motor Activity Log

  The Mal consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during activities of daily living. Two scores are given for each activity, 1 for the amount of use (AOU) and 1 for the quality of movement (QOM). The questions concern activities performed during the past week or, occasionally, the past year. Possible scores range from 0 (never use the affected arm for this activity) to 5 (always use the affected arm for this activity). (Van der Lee, Beckerman, Knol, de Vet, Bouter, 2004)

  First assessment (beginning)

• Change in System Usability Scale between 6th week and 12th week

  Third assessment (after 12 weeks)

• Change in Short Feedback Questionnaire between 6th week and 12th week

  Third assessment (after 12 weeks)

• Change in Fugl-Meyer Assessment upper extremity part (FMA)between baseline and 6th week

  Second assessment (after 6 weeks)

• Change in Fugl-Meyer Assessment upper extremity part (FMA)between 6th week and 12th week

  Third Assessment (after 12 weeks)

• Change in Motor Activity Log between baseline and 6th week

  Second assessment (after 6 weeks)

• Change in Motor Activity Log between 6th week and 12th week

  Third assessment (after 12 weeks)

Secondary Outcomes (5)

• Range of Motion (ROM) of shoulder and elbow

  First, second and third assessments (beginning, 6 & 12 weeks respectively)

• Visual Analog Scale (VAS)

  Second and third assessments (6 & 12 weeks respectively)

• Instrumental Activities of Daily Living (IADL)

  First and third assessments (beginning & 12 weeks respectively)

• Functional Independence Measure (FIM)

  First and third assessments (beginning & 12 weeks respectively)

• Stroke Impact Scale (SIS)

  First and third assessments (beginning & 12 weeks respectively)

Other Outcomes (2)

• NIHSS

  Beginning

• Behavioral Assessment of the Dysexecutive Syndrome (BADS)

  Beginning

Study Arms (1)

Single arm study

EXPERIMENTAL

The clients will receive tele-rehabilitation treatment via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback is given in the form of Knowledge of results (game scores) and Knowledge of performance (feedback of compensatory movements made while using the upper extremity) to enhance motor learning. The software generates a report which includes the duration and type of exercises performed by the subject.

Device: Tele Rehabilitation

Interventions

Tele Rehabilitation DEVICE

Also known as: Gertner Institute Tele Motion Rehabilitation system

Single arm study

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (1)

Neurology Department, Bat Yamon Medical Center

Bat Yam, Israel

Location

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Shlomo Flechter, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 27, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 6, 2021

Record last verified: 2013-06

Locations

IL (1)