Evaluation of the Gertner Tele-Motion-Rehabilitation System for Stroke Rehabilitation — GertnerTMR  

Stroke Clinical Trial

Official title: Randomized Controlled Trial of Gertner Tele-Motion-Rehabilitation

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT01655264
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Patrice (Tamar) L Weiss, Ph.D
• Phone: +972 52 869-9852
• Email: plweiss@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: July 2012
• Completion date: March 2013