Evaluation of the Gertner Tele-Motion-Rehabilitation System for Stroke Rehabilitation
NCT ID: NCT01655264
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
24 participants
INTERVENTIONAL
2012-07-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Home-based self training exercises
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.
Home-based self training exercises for weak upper extremity
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
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.
Tele-rehabilitation exercises for weak upper extremity
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Home-based self training exercises for weak upper extremity
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 extremity
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sheba Medical Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mordechai Shani, MD
Role: PRINCIPAL_INVESTIGATOR
Gertner Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sheba Medical Center
Ramat Gan, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Patrice (Tamar) L Weiss, PhD
Role: primary
Yoram Feldman, MBA
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
Borg 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.
Breivik 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.
Dodds 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.
Fugl-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.
Granger 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.
Katz-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.
Kizony 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.
Lawton 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.
Lawton 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.
Morris 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.
Ogon 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.
Stroke 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.
Wolf SL, Lecraw DE, Barton LA, Jann BB. Forced use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol. 1989 May;104(2):125-32. doi: 10.1016/s0014-4886(89)80005-6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHEBA-08-5641-MS-CTIL
Identifier Type: -
Identifier Source: org_study_id