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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01655264
First received: July 30, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Home-based self training exercises for weak upper extremity
Behavioral: Tele-rehabilitation exercises for weak upper extremity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Gertner Tele-Motion-Rehabilitation

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Range of Motion (ROM) of shoulder and elbow [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Functional Reach Test (FRT) [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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).

  • Instrumental Activities of Daily Living [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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).

  • Fugl-Meyer Motor Assessment (FMA) upper extremity sub-test [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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).

  • Visual Analog Scale (VAS)for pain evaluation [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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.

  • Functional Independence Measure (FIM) [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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).

  • Stroke Impact Scale (SIS) [ Time Frame: Change from baseline following four week intervention ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655264

Contacts
Contact: Patrice (Tamar) L Weiss, Ph.D +972 52 869-9852 plweiss@gmail.com
Contact: Yoram Feldman, MBA +972 52 666-7062 yoramfeld@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Patrice (Tamar) L Weiss, PhD    +972-52-869-9852    plweiss@gmail.com   
Contact: Yoram Feldman, MBA    +972-52-666-7062    yoramfeld@gmail.com   
Principal Investigator: Mordechai Shani, MD         
Sub-Investigator: Patrice (Tamar) L Weiss, BSOT,MS,PhD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Mordechai Shani, MD Gertner Institute
  More Information

Publications:

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01655264     History of Changes
Other Study ID Numbers: SHEBA-08-5641-MS-CTIL
Study First Received: July 30, 2012
Last Updated: October 10, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Stroke
Tele-health
Rehabilitation
Intervention
Gesture recognition system

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014