StrokeGertnerTMRNCT01655264
Evaluation of the Gertner Tele-Motion-Rehabilitation System for Stroke Rehabilitation
A study testing Home-based self training exercises for weak upper extremity and Tele-rehabilitation exercises for weak upper extremity in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The overall goal of the study is to evaluate the clinical effectiveness of a home-based tele-motion-rehabilitation (TMR) program in improving functional status of people who had stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Home-based self training exercises for weak upper extremity and Tele-rehabilitation exercises for weak upper extremity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Mar 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke (as verified via CT or MRI), 2- 72 months post event
- Moderate impairment of the affected upper extremity
- Preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO) (FIM of 6 indoors)
Who cannot join
- Other medical conditions limiting participation in a low-intensity exercise training
- Major receptive aphasia or inability to follow 2-stage commands and screening criteria consistent with dementia (Mini-Mental State score <24)
- Untreated major depression
- Presence of unilateral spatial neglect as determined by star cancellation (score less than 51)
- Hemianopsia
- Apraxia (limb and ideomotor)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Patrice (Tamar) L Weiss, PhD, +972-52-869-9852, plweiss@gmail.com
Yoram Feldman, MBA, +972-52-666-7062, yoramfeld@gmail.com
About this study
Official title: Randomized Controlled Trial of Gertner Tele-Motion-Rehabilitation
The overall goal of the study is to evaluate the clinical effectiveness of a home-based tele-motion-rehabilitation (TMR) program in improving functional status of people who had stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the hospital of the TMR will be greater in comparison to self-training exercise carried out at home in improving outcomes of Range of Motion and functional performance of the weak upper extremity.
Twenty-four subjects who had a stroke, aged between 18 and 80 years, and living at home will participate. Subjects will be 2-72 months post stroke, and no longer receiving rehabilitation as in or out patient. They will have moderate impairment of the affected upper extremity determined by range of motion (ROM). Subjects will be evaluated for motor and cognitive abilities for a total of 5-6 hours by a skilled therapist who will be blind to group's assignment of the subjects. The evaluations will be repeated 3 times, once before the intervention commences, once immediately following the intervention and once four weeks after the intervention.
Read more
Subjects will be randomized into the two groups (TMR versus self-training treatment) with matching for level of impairment of the upper extremity by a person who is not part of the study. Each subject will receive twelve 45-60 min sessions over 4 weeks while seated. The control group will receive self-training exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. The experimental group will receive TMR treatment of comparable duration and intensity to those in the conventional treatment group with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject.
The Gertner TMR system is implemented via Microsoft's Kinect three-dimensional) camera-based gesture recognition technology. Using the patient's natural hand and body movements control all activity within customized computer games. The system runs off a standard desktop computer and is displayed on a large television screen.
Read the detailed description
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. Telerehabilitation holds significant potential to meet this need and to provide services that are more accessible to more people, while having the ability to offer a more affordable enhanced level of care.
The overall goal of the study is to evaluate the clinical effectiveness of a home-based tele-motion-rehabilitation (TMR) program in improving functional status of people who had stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the hospital of the TMR will be greater in comparison to self-training exercise carried out at home in improving function of the weak upper extremity and performance of Activities of Daily Living.
Twenty-four subjects who had a stroke (as verified via CT or MRI), aged between 18 and 80 years, and living at home with a caregiver will participate. Subjects will be 2-72 months post stroke, and no longer receiving rehabilitation as in or out patient. They will have 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 30 degrees. Measures used to characterize their level of ability include: NIH Stroke Scale, Mini-Mental State Examination, Sensory evaluation (light touch, extinction, stereognosis, proprioception), and the Behavioral Assessment of the Dysexecutive Syndrome (BADS); these will not be used as study outcome measures.
The subjects will be evaluated over 2 sessions on different days for a total of 5-6 hours. The second session will include the setting of treatment goals for either treatment condition. Primary outcome measures will include Range of Motion (ROM) of the shoulder, elbow and trunk, the Chedoke Arm and Hand Activity Inventory (CAHAI), and the Motor Activity Log (MAL). Secondary outcome measures will include the Functional Reach Test (FRT) (in sitting and standing), the Fugl-Meyer Assessment (FMA), Visual Analog Scale (VAS) for Pain evaluation, Functional Independence Measure (FIM), Instrumental Activities of Daily Living (IADL), Stroke Impact Scale (SIS). Responses to the tele game activities will be monitored by using the following tool: BORG scale of perceived effort, Short Feedback Questionnaire (SFQ), Tele-game scores, and arm and trunk 3-Dimensional kinematics; these will not be used as outcome measures.
Subjects will be randomized into the two groups (12 in tele and 12 in self-training treatment) such that the two groups will be matched for level of impairment of the upper extremity. Each subject will receive twelve 45-60 min sessions (3 sessions per week for 4 weeks) of one of two types of treatment while seated. The control group will receive self-training exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise.
The experimental group will receive tele-rehabilitation treatment of comparable duration and intensity to those in the conventional treatment group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room.
The Gertner Tele-Motion-Rehabilitation system is implemented via Microsoft's Kinect three-dimensional) camera-based gesture recognition technology without any additional accessories (i.e., with no need for head mounted helmets or gloves). Using the patient's natural hand and body movements control all activity within customized computer games. The system runs off a standard desktop computer and is displayed on a large television screen. The patient may see himself (whole body or hands) within the virtual environment or may only see virtual objects that he is manipulating.
Each subject meeting the inclusion criteria will sign an informed consent. Subjects will be randomly assigned into one of two groups by a person who is not part of the study. Each subject will be assessed with the outcome tests listed above by a skilled therapist who will be blind to group's assignment of the subjects. The evaluations will be repeated 3 times, once before the intervention commences, once immediately following the intervention and once four weeks after the intervention.
- Conditions
- Stroke
- Being tested
- Home-based self training exercises for weak upper extremity, Tele-rehabilitation exercises for weak upper extremity
- Keywords
- Stroke, Tele-health, Rehabilitation, Intervention, Gesture recognition system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based self training exercises for weak upper extremityBehavioural
Each subject in the control group will receive twelve 45-60 min sessions (3 sessions per week for 4 weeks) while seated. They will receive self-training upper extremity exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise.
Tele-rehabilitation exercises for weak upper extremityBehavioural
The experimental group will receive tele-rehabilitation upper extremity exercises treatment of comparable duration and intensity to those in the home-based self training exercise treatment group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room.
| Study group | Role | What they receive |
|---|---|---|
| Home-based self training exercises | Active comparator | The control group will receive home-based self-training exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise. Receives: Behavioral: Home-based self training exercises for weak upper extremity |
| Tele-rehabilitation exercises | Experimental | The experimental group will receive tele-rehabilitation treatment of comparable duration and intensity to those in the home-based self training exercise group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room. Receives: Behavioral: Tele-rehabilitation exercises for weak upper extremity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Change from baseline following four week intervention
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
Global arm function will be tested using the Chedoke Arm and Hand Activity Inventory (CAHAI-7), a valid and reliable scale of daily arm activities (Barreca et al. 2004; 2005).
Measured: Change from baseline following four week intervention
Motor Activity Log (MAL)
The MAL is a structured questionnaire designed to assess the self-perceived use of the more- impaired arm after stroke while performing a wide range of basic and instrumental activities of daily life (BADL, IADL). The questionnaire examines both the patient's perception of the Amount of arm Use (AOU) and his/her satisfaction with the Quality of Movement (QOM). High internal consistency (Chronbach's α=0.87-0.95) and discriminative validity was established and it correlates well with other assessments of daily function. It was found to be stable and sensitive to patient responses. High correlation were found between the patient responses and caregiver scale responses (ICC= 0.52, p<0.05). A Pearson's correlation of 0.7 (p<0.5) was found in comparing between the patient responses and accelerometer recordings (Uswatte et al., 2006).
Measured: Change from baseline following four week intervention
Secondary outcomes (6)
Functional Reach Test (FRT)
Functional Reach Test (FRT) (in sitting and standing)measures the distance of arm reaching during a forward and then during a sideways leaning reaching task(mean of three measurements in each direction). It has been shown to be reliable and valid (Katz-Leurer et al., 2009).
Measured: Change from baseline following four week intervention
Instrumental Activities of Daily Living
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: Change from baseline following four week intervention
Fugl-Meyer Motor Assessment (FMA) upper extremity sub-test
Fugl-Meyer Motor Assessment (FMA) upper extremity sub-test (Fugl-Meyer et al., 1975) assesses the motor impairment of the weak upper extremity (scores range from 0-60 points). It is a valid and reliable assessment (Morris, Uswatte, Crago, Edwin, \& Taub, 2001; Wolf, Lecraw, Barton, \& Jann, 1989).
Measured: Change from baseline following four week intervention
Visual Analog Scale (VAS)for pain evaluation
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: Change from baseline following four week intervention
Functional Independence Measure (FIM)
Functional Independence Measure (FIM) (Granger, 1993) will be used to characterize the functional status of the participant pre-post training. It has been validated as an assessment of performance among rehabilitation in-patients (Stolov \& Deyo,1993).
Measured: Change from baseline following four week intervention
Stroke Impact Scale (SIS)
Stroke Impact Scale (SIS) (University of Kansas, 2008, http://www2.kumc.edu/coa/ SIS/SIS_pg2.htm ) 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).
Measured: Change from baseline following four week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mordechai Shani, MD, Principal investigator, Gertner Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655264
- Sponsor's protocol ID
- SHEBA-08-5641-MS-CTIL
- Acronym
- GertnerTMR
- Status last verified
- Oct 2012
- First submitted
- 30 Jul 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Barreca SR, Stratford PW, Lambert CL, Masters LM, Streiner DL. Test-retest reliability, validity, and sensitivity of the Chedoke arm and hand activity inventory: a new measure of upper-limb function for survivors of stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1616-22. doi: 10.1016/j.apmr.2005.03.017.
PubMed 16084816Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. doi: 10.5271/sjweh.1815.
PubMed 2345867Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000 Mar;16(1):22-8. doi: 10.1097/00002508-200003000-00005.
PubMed 10741815Dodds TA, Martin DP, Stolov WC, Deyo RA. A validation of the functional independence measurement and its performance among rehabilitation inpatients. Arch Phys Med Rehabil. 1993 May;74(5):531-6. doi: 10.1016/0003-9993(93)90119-u.
PubMed 8489365Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Granger CV, Hamilton BB, Linacre JM, Heinemann AW, Wright BD. Performance profiles of the functional independence measure. Am J Phys Med Rehabil. 1993 Apr;72(2):84-9. doi: 10.1097/00002060-199304000-00005.
PubMed 8476548Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.
PubMed 18608433Kizony R, Katz N, Rand D, Weiss PL. A Short Feedback Questionnaire (SFQ) to enhance client-centered participation in virtual environments. Proceedings of 11th Annual Cybertherapy 2006.
Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
PubMed 4048757Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366Lawton MP, Moss M, Fulcomer M, Kleban MH. A research and service oriented multilevel assessment instrument. J Gerontol. 1982 Jan;37(1):91-9. doi: 10.1093/geronj/37.1.91.
PubMed 7053405Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
PubMed 11387578Ogon M, Krismer M, Sollner W, Kantner-Rumplmair W, Lampe A. Chronic low back pain measurement with visual analogue scales in different settings. Pain. 1996 Mar;64(3):425-428. doi: 10.1016/0304-3959(95)00208-1.
PubMed 8783305Stroke Impact Scale (SIS) (University of Kansas, 2008, http://www2.kumc.edu/coa/ SIS/SIS_pg2.htm
Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
PubMed 17030751
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Gertner Tele-Motion-Rehabilitation
- ClinicalTrials.gov ID
- NCT01655264
- Acronym / sponsor ID
- GertnerTMR / SHEBA-08-5641-MS-CTIL
- Conditions
- Stroke
- Keywords
- Stroke, Tele-health, Rehabilitation, Intervention, Gesture recognition system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 1 Aug 2012 (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.
The overall goal of the study is to evaluate the clinical effectiveness of a home-based tele-motion-rehabilitation (TMR) program in improving functional status of people who had stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the hospital of the TMR will be greater in comparison to self-training exercise carried out at home in improving outcomes of Range of Motion and functional performance of the weak upper extremity.
Twenty-four subjects who had a stroke, aged between 18 and 80 years, and living at home will participate. Subjects will be 2-72 months post stroke, and no longer receiving rehabilitation as in or out patient. They will have moderate impairment of the affected upper extremity determined by range of motion (ROM). Subjects will be evaluated for motor and cognitive abilities for a total of 5-6 hours by a skilled therapist who will be blind to group's assignment of the subjects. The evaluations will be repeated 3 times, once before the intervention commences, once immediately following the intervention and once four weeks after the intervention.
Subjects will be randomized into the two groups (TMR versus self-training treatment) with matching for level of impairment of the upper extremity by a person who is not part of the study. Each subject will receive twelve 45-60 min sessions over 4 weeks while seated. The control group will receive self-training exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. The experimental group will receive TMR treatment of comparable duration and intensity to those in the conventional treatment group with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject.
The Gertner TMR system is implemented via Microsoft's Kinect three-dimensional) camera-based gesture recognition technology. Using the patient's natural hand and body movements control all activity within customized computer games. The system runs off a standard desktop computer and is displayed on a large television screen.
Detailed description
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. Telerehabilitation holds significant potential to meet this need and to provide services that are more accessible to more people, while having the ability to offer a more affordable enhanced level of care.
The overall goal of the study is to evaluate the clinical effectiveness of a home-based tele-motion-rehabilitation (TMR) program in improving functional status of people who had stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the hospital of the TMR will be greater in comparison to self-training exercise carried out at home in improving function of the weak upper extremity and performance of Activities of Daily Living.
Twenty-four subjects who had a stroke (as verified via CT or MRI), aged between 18 and 80 years, and living at home with a caregiver will participate. Subjects will be 2-72 months post stroke, and no longer receiving rehabilitation as in or out patient. They will have 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 30 degrees. Measures used to characterize their level of ability include: NIH Stroke Scale, Mini-Mental State Examination, Sensory evaluation (light touch, extinction, stereognosis, proprioception), and the Behavioral Assessment of the Dysexecutive Syndrome (BADS); these will not be used as study outcome measures.
The subjects will be evaluated over 2 sessions on different days for a total of 5-6 hours. The second session will include the setting of treatment goals for either treatment condition. Primary outcome measures will include Range of Motion (ROM) of the shoulder, elbow and trunk, the Chedoke Arm and Hand Activity Inventory (CAHAI), and the Motor Activity Log (MAL). Secondary outcome measures will include the Functional Reach Test (FRT) (in sitting and standing), the Fugl-Meyer Assessment (FMA), Visual Analog Scale (VAS) for Pain evaluation, Functional Independence Measure (FIM), Instrumental Activities of Daily Living (IADL), Stroke Impact Scale (SIS). Responses to the tele game activities will be monitored by using the following tool: BORG scale of perceived effort, Short Feedback Questionnaire (SFQ), Tele-game scores, and arm and trunk 3-Dimensional kinematics; these will not be used as outcome measures.
Subjects will be randomized into the two groups (12 in tele and 12 in self-training treatment) such that the two groups will be matched for level of impairment of the upper extremity. Each subject will receive twelve 45-60 min sessions (3 sessions per week for 4 weeks) of one of two types of treatment while seated. The control group will receive self-training exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise.
The experimental group will receive tele-rehabilitation treatment of comparable duration and intensity to those in the conventional treatment group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room.
The Gertner Tele-Motion-Rehabilitation system is implemented via Microsoft's Kinect three-dimensional) camera-based gesture recognition technology without any additional accessories (i.e., with no need for head mounted helmets or gloves). Using the patient's natural hand and body movements control all activity within customized computer games. The system runs off a standard desktop computer and is displayed on a large television screen. The patient may see himself (whole body or hands) within the virtual environment or may only see virtual objects that he is manipulating.
Each subject meeting the inclusion criteria will sign an informed consent. Subjects will be randomly assigned into one of two groups by a person who is not part of the study. Each subject will be assessed with the outcome tests listed above by a skilled therapist who will be blind to group's assignment of the subjects. The evaluations will be repeated 3 times, once before the intervention commences, once immediately following the intervention and once four weeks after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based self training exercises | Active comparator | Behavioral: Home-based self training exercises for weak upper extremityThe control group will receive home-based self-training exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise. |
| Tele-rehabilitation exercises | Experimental | Behavioral: Tele-rehabilitation exercises for weak upper extremityThe experimental group will receive tele-rehabilitation treatment of comparable duration and intensity to those in the home-based self training exercise group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke (as verified via CT or MRI), 2- 72 months post event
- Moderate impairment of the affected upper extremity
- Preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO) (FIM of 6 indoors)
Key exclusion criteria (6 listed)
- Other medical conditions limiting participation in a low-intensity exercise training
- Major receptive aphasia or inability to follow 2-stage commands and screening criteria consistent with dementia (Mini-Mental State 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 |
|---|---|---|
| Home-based self training exercises for weak upper extremityEach subject in the control group will receive twelve 45-60 min sessions (3 sessions per week for 4 weeks) while seated. They will receive self-training upper extremity exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise. | Behavioural | Home-based self training exercises |
| Tele-rehabilitation exercises for weak upper extremityThe experimental group will receive tele-rehabilitation upper extremity exercises treatment of comparable duration and intensity to those in the home-based self training exercise treatment group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be 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 will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room. | Behavioural | Tele-rehabilitation exercises |
Primary outcome
Range of Motion (ROM) of shoulder and elbow
Time frame: Change from baseline following four week intervention
Standard clinical goniometer will be used to measure changes in shoulder (abduction and flexion) and elbow flexion Range of Motion angles in degrees.
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
Time frame: Change from baseline following four week intervention
Global arm function will be tested using the Chedoke Arm and Hand Activity Inventory (CAHAI-7), a valid and reliable scale of daily arm activities (Barreca et al. 2004; 2005).
Motor Activity Log (MAL)
Time frame: Change from baseline following four week intervention
The MAL is a structured questionnaire designed to assess the self-perceived use of the more- impaired arm after stroke while performing a wide range of basic and instrumental activities of daily life (BADL, IADL). The questionnaire examines both the patient's perception of the Amount of arm Use (AOU) and his/her satisfaction with the Quality of Movement (QOM). High internal consistency (Chronbach's α=0.87-0.95) and discriminative validity was established and it correlates well with other assessments of daily function. It was found to be stable and sensitive to patient responses. High correlation were found between the patient responses and caregiver scale responses (ICC= 0.52, p<0.05). A Pearson's correlation of 0.7 (p<0.5) was found in comparing between the patient responses and accelerometer recordings (Uswatte et al., 2006).
6 secondary outcomes
Functional Reach Test (FRT)
Time frame: Change from baseline following four week intervention
Instrumental Activities of Daily Living
Time frame: Change from baseline following four week intervention
Fugl-Meyer Motor Assessment (FMA) upper extremity sub-test
Time frame: Change from baseline following four week intervention
Visual Analog Scale (VAS)for pain evaluation
Time frame: Change from baseline following four week intervention
Functional Independence Measure (FIM)
Time frame: Change from baseline following four week intervention
Stroke Impact Scale (SIS)
Time frame: Change from baseline following four week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
- Background: PubMed 16084816Barreca SR, Stratford PW, Lambert CL, Masters LM, Streiner DL. Test-retest reliability, validity, and sensitivity of the Chedoke arm and hand activity inventory: a new measure of upper-limb function for survivors of stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1616-22. doi: 10.1016/j.apmr.2005.03.017.
- Background: PubMed 2345867Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. doi: 10.5271/sjweh.1815.
- Background: PubMed 10741815Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000 Mar;16(1):22-8. doi: 10.1097/00002508-200003000-00005.
- Background: PubMed 8489365Dodds TA, Martin DP, Stolov WC, Deyo RA. A validation of the functional independence measurement and its performance among rehabilitation inpatients. Arch Phys Med Rehabil. 1993 May;74(5):531-6. doi: 10.1016/0003-9993(93)90119-u.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 8476548Granger CV, Hamilton BB, Linacre JM, Heinemann AW, Wright BD. Performance profiles of the functional independence measure. Am J Phys Med Rehabil. 1993 Apr;72(2):84-9. doi: 10.1097/00002060-199304000-00005.
- Background: PubMed 18608433Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.
- BackgroundKizony R, Katz N, Rand D, Weiss PL. A Short Feedback Questionnaire (SFQ) to enhance client-centered participation in virtual environments. Proceedings of 11th Annual Cybertherapy 2006.
- Background: PubMed 4048757Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
- Background: PubMed 5349366Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
- Background: PubMed 7053405Lawton MP, Moss M, Fulcomer M, Kleban MH. A research and service oriented multilevel assessment instrument. J Gerontol. 1982 Jan;37(1):91-9. doi: 10.1093/geronj/37.1.91.
- Background: PubMed 11387578Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
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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.
Mordechai Shani, MD principal investigator
Gertner Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based self training exercises for weak upper extremity and Tele-rehabilitation exercises for weak upper extremity in people with Stroke, run by Sheba Medical Center 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice (Tamar) L Weiss, Ph.D (+972 52 869-9852, plweiss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) of shoulder and elbow (time frame: Change from baseline following four week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655264, which also lists 16 linked publications.
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 11 Oct 2012.