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

NCT01655264 | Unknown

• 1 other identifier: SHEBA-08-5641-MS-CTIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Tele-health; Rehabilitation; Intervention; Gesture recognition system

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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).

  Change from baseline following four week intervention

Secondary Outcomes (6)

• Functional Reach Test (FRT)

  Change from baseline following four week intervention

• Instrumental Activities of Daily Living

  Change from baseline following four week intervention

• Fugl-Meyer Motor Assessment (FMA) upper extremity sub-test

  Change from baseline following four week intervention

• Visual Analog Scale (VAS)for pain evaluation

  Change from baseline following four week intervention

• Functional Independence Measure (FIM)

  Change from baseline following four week intervention

Study Arms (2)

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.

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.

Behavioral: Tele-rehabilitation exercises for weak upper extremity

Interventions

Home-based self training exercises for weak upper extremity BEHAVIORAL

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.

Home-based self training exercises

Tele-rehabilitation exercises for weak upper extremity BEHAVIORAL

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.

Tele-rehabilitation exercises

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (16)

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  PMID: 10741815 BACKGROUND

• 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.

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  PMID: 1135616 BACKGROUND

• 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.

  PMID: 8476548 BACKGROUND

• 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.

  PMID: 18608433 BACKGROUND

• 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.

  BACKGROUND

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• 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.

  PMID: 7053405 BACKGROUND

• 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.

  PMID: 11387578 BACKGROUND

• 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.

  PMID: 8783305 BACKGROUND

• Stroke Impact Scale (SIS) (University of Kansas, 2008, http://www2.kumc.edu/coa/ SIS/SIS_pg2.htm

  BACKGROUND

• 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.

  PMID: 17030751 BACKGROUND

• 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.

  PMID: 2707361 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mordechai Shani, MD

  Gertner Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrice (Tamar) L Weiss, Ph.D

CONTACT

+972 52 869-9852; plweiss@gmail.com

Yoram Feldman, MBA

CONTACT

+972 52 666-7062; yoramfeld@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

IL (1)