StrokeNCT01887756
Research Online Tele-Rehabilitation Program in People After a Stroke Living at Home
A study testing Tele Rehabilitation in people with Stroke, run by Clalit Health Services at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Tele Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research and Clinical Aspects of the Project Study of Home Based Tele-Rehabilitation Program for Patients With Stroke
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
- To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab system in post-stroke patients, in their homes.
- To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's home in terms of:
- function of the weak upper extremity
- performance of ADL
- Conditions
- Stroke
- Being tested
- Tele Rehabilitation
- Keywords
- telerehabilitation stroke virtual reatlity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele RehabilitationDevice
Also called Gertner Institute Tele Motion Rehabilitation system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tele Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: First assessment (beginning)
Change in System Usability Scale between 6th week and 12th week
Measured: Third assessment (after 12 weeks)
Change in Short Feedback Questionnaire between 6th week and 12th week
Measured: Third assessment (after 12 weeks)
Change in Fugl-Meyer Assessment upper extremity part (FMA)between baseline and 6th week
Measured: Second assessment (after 6 weeks)
Change in Fugl-Meyer Assessment upper extremity part (FMA)between 6th week and 12th week
Measured: Third Assessment (after 12 weeks)
Change in Motor Activity Log between baseline and 6th week
Measured: Second assessment (after 6 weeks)
Change in Motor Activity Log between 6th week and 12th week
Measured: Third assessment (after 12 weeks)
Secondary outcomes (5)
Range of Motion (ROM) of shoulder and elbow
Standard clinical goniometer will be used to measure changes in shoulder (abduction and flexion) and elbow flexion Range of Motion angles in degrees.
Measured: First, second and third assessments (beginning, 6 & 12 weeks respectively)
Visual Analog Scale (VAS)
for Pain evaluation will be used to document pain intensity, and rated from 0 to 10. The VAS is a 10 cm line representing pain intensity from "no pain" (0) to "worst pain" (10). Subjects will be requested to bisect the line at the point that best represented their level of neck pain. The VAS has been recognized as a generic pain intensity instrument for over two decades (Langley \& Sheppard, 1985) and has been found valid and sensitive to changes in acute (Breivik et al., 2000) and chronic (Ogon et al., 1996) pain.
Measured: Second and third assessments (6 & 12 weeks respectively)
Instrumental Activities of Daily Living (IADL)
A questionnaire which evaluates the subject's capacity to perform eight different IADL tasks such as cooking, the use of transportation, shopping and taking medication (Lawton \& Brody, 1969; Lawton et al., 1982).
Measured: First and third assessments (beginning & 12 weeks respectively)
Functional Independence Measure (FIM)
FIM rates the degree of disability and outcome after rehabilitation. It assesses 18 components of basic activities of daily living (e.g. dressing) and used here to characterize functional status. Thirteen activities (in areas of eating, dressing, grooming, bathing, toileting, transfers and mobility) constitute the motor part of the FIM and five (in areas of comprehension, expression, social relations, problem solving and memory) constitute the cognitive part of the FIM. Each activity is graded on a seven point scale with a total score range between 13-91 for the motor part and 5-35 for the cognitive part. The reliability and validity is well established (Granger, 1998). It was found suitable to use with patients who had a stroke (Ring et al., 1997; Granger Cotter, Hamilton \& Fiedler, 1993) and also has been used for people with SCI (Sipski, Jackson, Gomez-Marin, Estores\&Stein, 2004). (Hamilton Granger, Sherwin, Zielezny\&Tashman, 1987).
Measured: First and third assessments (beginning & 12 weeks respectively)
Stroke Impact Scale (SIS)
SIS is a self-report that each participant will complete regarding his or her overall quality of life, including perceived difficulties with activities of daily living (ADL). (University of Kansas, 2008, http://www2.kumc.edu/coa/ SIS/SIS_pg2.htm )
Measured: First and third assessments (beginning & 12 weeks respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Halted before intervention due to approval of service.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shlomo Flechter, Clalit Health Services
- Investigators
- Shlomo Flechter, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887756
- Sponsor's protocol ID
- GTR-Motion
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Clinical Aspects of the Project Study of Home Based Tele-Rehabilitation Program for Patients With Stroke
- ClinicalTrials.gov ID
- NCT01887756
- Acronym / sponsor ID
- GTR-Motion
- Conditions
- Stroke
- Keywords
- telerehabilitation stroke virtual reatlity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted before intervention due to approval of service.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab system in post-stroke patients, in their homes.
- To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's home in terms of:
- function of the weak upper extremity
- performance of ADL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Device: Tele RehabilitationThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele RehabilitationAlso: Gertner Institute Tele Motion Rehabilitation system | Device | Single arm study |
Primary outcome
System usability scale
Time frame: Second assessment (after 6 weeks)
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)
Short Feedback Questionnaire
Time frame: Second assessment ( after 6 week)
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)
Fugl-Meyer Assessment upper extremity part (FMA)
Time frame: First assessment (beginning)
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).
Motor Activity Log
Time frame: First assessment (beginning)
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)
Change in System Usability Scale between 6th week and 12th week
Time frame: Third assessment (after 12 weeks)
Change in Short Feedback Questionnaire between 6th week and 12th week
Time frame: Third assessment (after 12 weeks)
Change in Fugl-Meyer Assessment upper extremity part (FMA)between baseline and 6th week
Time frame: Second assessment (after 6 weeks)
Change in Fugl-Meyer Assessment upper extremity part (FMA)between 6th week and 12th week
Time frame: Third Assessment (after 12 weeks)
Change in Motor Activity Log between baseline and 6th week
Time frame: Second assessment (after 6 weeks)
Change in Motor Activity Log between 6th week and 12th week
Time frame: Third assessment (after 12 weeks)
5 secondary outcomes
Range of Motion (ROM) of shoulder and elbow
Time frame: First, second and third assessments (beginning, 6 & 12 weeks respectively)
Visual Analog Scale (VAS)
Time frame: Second and third assessments (6 & 12 weeks respectively)
Instrumental Activities of Daily Living (IADL)
Time frame: First and third assessments (beginning & 12 weeks respectively)
Functional Independence Measure (FIM)
Time frame: First and third assessments (beginning & 12 weeks respectively)
Stroke Impact Scale (SIS)
Time frame: First and third assessments (beginning & 12 weeks respectively)
Results and safety
The study was stopped early (reason given: Halted before intervention due to approval of service.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Flechter, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele Rehabilitation in people with Stroke, run by Clalit Health Services at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Halted before intervention due to approval of service.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System usability scale (time frame: Second assessment (after 6 weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.