Enriched Environments for Upper Limb Stroke Rehabilitation

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01388400
First received: June 12, 2011
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

Stroke contributes significantly to the incidence of disabilities, with upper limb (UL) motor impairment being especially prevalent. Animal studies suggest that post-stroke motor recovery is largely attributable to adaptive plasticity in brain motor areas. While some environmental training factors contributing to plastic mechanisms have been identified in animals, translation of this knowledge to the clinical setting is insufficient. Optimal recovery may be related to both external (e.g., feedback type) and internal factors (e.g., cognitive ability, motivation). Clinically feasible methods for training are needed. Use of enriched virtual environments (VEs) may provide a way to address these needs. Outcome measures that best reflect recovery need to be identified since this is an essential step to evaluate the effect of novel training programs for UL motor recovery in stroke.

The research question is which clinical and kinematic outcome measures best reflect motor performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare changes in outcome measures recorded before and after an upper limb intervention in stroke subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance between-group differences sample size is based on knowledge of expected outcome measure mean score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome measures will be sensitive to within-group (pre-post intervention training) changes. Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to between-group (healthy vs. patients in enriched vs. conventional intervention groups. Sixteen chronic stroke survivors and 8 age- and sex-matched healthy controls will participate. Patients will be matched on cognitive and motor impairment levels and divided into two groups. Using an single subject (A-B-A) research design, kinematics during two pre-tests, 3 weeks apart, will be recorded for test-retest reliability. Stroke groups will practice varied upper limb reaching movements (15 45-minute sessions in 3 weeks) in environments providing different motivation/feedback levels. Pre- and post motor performance evaluations will be done with clinical tests and a Test Task with specific motor performance requirements. A Transfer Task will also be recorded. By comparing data analysis methods (3-Dimensional (3D) analysis of different markers or placements), the investigators will identify which kinematic outcome measures best reflect motor improvement in post-test and follow-up sessions (retention).

The expected results are identification of two primary and two secondary outcome measures that reflect upper limb motor recovery and can distinguish between motor recovery and compensation. The results will be used to design a randomized control trial to determine the efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic (environmental) and intrinsic (personal) motivational factors affect motor learning in stroke survivors with cognitive and physical impairment. Knowledge gained can also be used for rehabilitation of other neurological and orthopedic pathologies.


Condition Intervention
Stroke
Other: conventional occupational therapy
Device: video capture virtual reality

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Enriched Environments for Stroke Rehabilitation; Pilot Study to Determine Appropriate Outcome Measures and Their Sensitivity to Different Training Protocols

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Post test Wolf Motor Function Test [ Time Frame: Change from baseline after 3 week treatment intervention ] [ Designated as safety issue: No ]
    Wolf Motor Function Test (WMFT; Wolf et al., 1989) assessed upper limb motor function (quality and speed) on 15 functional tasks scored on 6-point (0-5) scales as well as 2 strength (grip strength and resistance while lifting or moving weighted objects) measures (Wolf et al., 2001). The tasks are arranged in order of increasing complexity and progress from proximal to distal joint involvement. The WMFT has high interrater (Interclass Correlation Coefficient =0.97-0.99), as well as test-retest reliability (0.90 for performance time and 0.95 for performance quality).

  • Follow-up Wolf Motor Function Test [ Time Frame: Change from baseline 4 weeks after end of treatment intervention ] [ Designated as safety issue: No ]
    Wolf Motor Function Test (WMFT; Wolf et al., 1989) assessed upper limb motor function (quality and speed) on 15 functional tasks scored on 6-point (0-5) scales as well as 2 strength (grip strength and resistance while lifting or moving weighted objects) measures (Wolf et al., 2001). The tasks are arranged in order of increasing complexity and progress from proximal to distal joint involvement. The WMFT has high interrater (Interclass Correlation Coefficient =0.97-0.99), as well as test-retest reliability (0.90 for performance time and 0.95 for performance quality).


Secondary Outcome Measures:
  • Post test Fugl-Meyer Arm Scale [ Time Frame: Change from baseline after 3 week treatment intervention ] [ Designated as safety issue: No ]
    Fugl-Meyer Arm Scale (FMA; Fugl-Meyer, 1975) was developed to assess active motor function after stroke, based on the stages of recovery described by Twitchell and Brunnstrom (Sanford et al., 1993). Movements are scored between 0-2 points, and the summary score ranges from 0 (complete paralysis) to 66 (full ROM). The assessment has high validity (Berglund and Fugl-Meyer 1986) and reliability (Duncan et al. 1983) composite test-retest = 0.98-0.99; Interclass Correlation Coefficient for interrater reliability=0.96, p<0.0001; internal reliability = 90.7%) (Wolf et al., 2001).

  • Post test Composite Spasticity Index [ Time Frame: Change from baseline after 3 week treatment intervention ] [ Designated as safety issue: No ]
    Composite Spasticity Index (CSI, Levin and Hui-Chan, 1992) assessed phasic (tendon jerk, clonus) and tonic (resistance to stretch) reflex responses in the elbow flexors when the limb was stretched at a moderate speed (>100/second). The valid (Nadeau et al. 1997) and reliable (Goulet et al. 1996) composite score ranges from 0 to 16 where scores of 0 to 6, 7 to 9 and 10 to 12 correspond to mild, moderate and severe spasticity respectively.

  • Post test Reaching Performance Scale [ Time Frame: Change from baseline after 3 week treatment intervention ] [ Designated as safety issue: No ]
    Reaching Performance Scale (RPSS; Levin et al., 2004) evaluated performance of reaching and grasping tasks to objects placed within (RPSSnear) and beyond (RPSSfar) arm's length. Performance of 6 movement components is scored on 4-point (0-3) scales, for a total of 18 points per task. The RPSS scores correlate significantly with those of the Chedoke-McMaster Stroke Assessment and the Upper Extremity Performance Test for the Elderly (TEMPA) and discriminate between patients with different upper limb impairment levels. In addition, it was found to have good interrater reliability (67%).

  • Post test Box and Blocks Test [ Time Frame: Change from baseline after 3 week treatment intervention ] [ Designated as safety issue: No ]
    Box and Blocks Test (BBT; Mathiowetz et al., 1985) is a functional dexterity test that involves moving blocks from one side of a box to the other by passing them over a barrier. Performance is scored according to the number of blocks transferred in 1 minute with lower scores corresponding to greater upper limb impairments. The BBT has high test-retest (Interclass Correlation Coefficient =0.94 - 0.98; Cromwell, 1976; Canny et al., 2009) and interrater (Interclass Correlation Coefficient =1.00) reliability.

  • Post test Motor Activity Log [ Time Frame: Change from baseline after 3 week treatment intervention ] [ Designated as safety issue: No ]
    Motor Activity Log (MAL; Uswatte et al., 2006) 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. Each item is scored on a 6 point scale (0 - 5). The scale has high internal consistency (Chronbach's α=0.87-0.95) and discriminative validity and highly correlates with caregiver responses (Interclass Correlation Coefficient = 0.52, p<0.05) and accelerometer recordings of actual arm use (r=0.7, p<0.05; Uswatte et al., 2005; 2006).

  • upper limb kinematics [ Time Frame: One week before start of intervention ] [ Designated as safety issue: No ]
    Rigid body segmental kinematics will be recorded from sets of 4 passive reflective markers (0.5 cm diameter spheres) attached to the trunk, upper arm and forearm segments. This will enable the computation of three translational and three rotational degrees of freedom per segment. Marker motion will be recorded with a calibrated 3 camera optoelectronic motion-capture system (ProReflex MCU-240, Qualisys) on suitable PC software (QMT, Qualisys, Göteborg, Sweden). Data collection (100 Hrtz, 2-5 second) will be triggered by movement of the hand.

  • Follow-up Fugl-Meyer Arm Scale [ Time Frame: Change from baseline 4 weeks after end of treatment intervention ] [ Designated as safety issue: No ]
    Fugl-Meyer Arm Scale (FMA; Fugl-Meyer, 1975) was developed to assess active motor function after stroke, based on the stages of recovery described by Twitchell and Brunnstrom (Sanford et al., 1993). Movements are scored between 0-2 points, and the summary score ranges from 0 (complete paralysis) to 66 (full ROM). The assessment has high validity (Berglund and Fugl-Meyer 1986) and reliability (Duncan et al. 1983) composite test-retest = 0.98-0.99; Interclass Correlation Coefficient for interrater reliability=0.96, p<0.0001; internal reliability = 90.7%) (Wolf et al., 2001).

  • Follow-up Composite Spasticity Index [ Time Frame: Change from baseline 4 weeks after end of treatment intervention ] [ Designated as safety issue: No ]
    Composite Spasticity Index (CSI, Levin and Hui-Chan, 1992) assessed phasic (tendon jerk, clonus) and tonic (resistance to stretch) reflex responses in the elbow flexors when the limb was stretched at a moderate speed (>100/second). The valid (Nadeau et al. 1997) and reliable (Goulet et al. 1996) composite score ranges from 0 to 16 where scores of 0 to 6, 7 to 9 and 10 to 12 correspond to mild, moderate and severe spasticity respectively.

  • Follow-up Reaching Performance Scale [ Time Frame: Change from baseline 4 weeks after end of treatment intervention ] [ Designated as safety issue: No ]
    Reaching Performance Scale (RPSS; Levin et al., 2004) evaluated performance of reaching and grasping tasks to objects placed within (RPSSnear) and beyond (RPSSfar) arm's length. Performance of 6 movement components is scored on 4-point (0-3) scales, for a total of 18 points per task. The RPSS scores correlate significantly with those of the Chedoke-McMaster Stroke Assessment and the Upper Extremity Performance Test for the Elderly (TEMPA) and discriminate between patients with different upper limb impairment levels. In addition, it was found to have good interrater reliability (67%).

  • Follow-up Box and Blocks Test [ Time Frame: Change from baseline 4 weeks after end of treatment intervention ] [ Designated as safety issue: No ]
    Box and Blocks Test (BBT; Mathiowetz et al., 1985) is a functional dexterity test that involves moving blocks from one side of a box to the other by passing them over a barrier. Performance is scored according to the number of blocks transferred in 1 min with lower scores corresponding to greater upper limb impairments. The BBT has high test-retest (Interclass Correlation Coefficient =0.94 - 0.98; Cromwell, 1976; Canny et al., 2009) and interrater (Interclass Correlation Coefficient =1.00) reliability.

  • Follow-up Motor Activity Log [ Time Frame: Change from baseline 4 weeks after end of treatment intervention ] [ Designated as safety issue: No ]
    Motor Activity Log (MAL; Uswatte et al., 2006) 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. Each item is scored on a 6 point scale (0 - 5). The scale has high internal consistency (Chronbach's α=0.87-0.95) and discriminative validity and highly correlates with caregiver responses (Interclass Correlation Coefficient = 0.52, p<0.05) and accelerometer recordings of actual arm use (r=0.7, p<0.05; Uswatte et al., 2005; 2006).


Enrollment: 12
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional intervention for upper limb reaching
Reaching or holding cones, cups, etc. in all planes with and without gravity or loading
Other: conventional occupational therapy
upper limb exercises
Experimental: VR treatment
The Virtual Reality (VR) therapy group received the treatment in the GestureTek VR environment which focused on reaching movements of the affected upper limb using virtual games and a virtual supermarket.
Device: video capture virtual reality
virtual reality delivered uppe limb exercises

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for patients wth stroke:

  1. Age 40-80 years
  2. sustained a single stroke between 3-24 months prio t study leading to upper limb paresis
  3. have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale.
  4. <81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions

Exclusion Criteria for patients wth stroke:

  1. other neurological or orthopaedic problems that may interfere with interpretation of results
  2. significant deficits in attention, constructional skills, neglect and apraxia
  3. shoulder subluxation, arm pain
  4. lack of endurance as judged by a physician
  5. undergoing other therapy, surgery or medical procedures within the study period.

Inclusion Criteria for healthy control subjects:

1. Age 40-80 years

Exclusion Criteria for control subjects:

1. any neurological or orthopaedic problems that may interfere with interpretation of results.

  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: NCT01388400

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: Dr. Harold Weingarden, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01388400     History of Changes
Other Study ID Numbers: SHEBA-08-5120-HW-CTIL
Study First Received: June 12, 2011
Last Updated: July 10, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
stroke
rehabilitation
virtual reality
upper limb

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 July 28, 2014