Enriched Environments for Upper Limb Stroke Rehabilitation

NCT01388400 | Completed

• 1 other identifier: SHEBA-08-5120-HW-CTIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; virtual reality; upper limb

Outcome Measures

Primary Outcomes (2)

• Post test Wolf Motor Function Test

  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).

  Change from baseline after 3 week treatment intervention

• Follow-up Wolf Motor Function Test

  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).

  Change from baseline 4 weeks after end of treatment intervention

Secondary Outcomes (11)

• Post test Fugl-Meyer Arm Scale

  Change from baseline after 3 week treatment intervention

• Post test Composite Spasticity Index

  Change from baseline after 3 week treatment intervention

• Post test Reaching Performance Scale

  Change from baseline after 3 week treatment intervention

• Post test Box and Blocks Test

  Change from baseline after 3 week treatment intervention

• Post test Motor Activity Log

  Change from baseline after 3 week treatment intervention

Study Arms (2)

Conventional intervention for upper limb reaching

EXPERIMENTAL

Reaching or holding cones, cups, etc. in all planes with and without gravity or loading

Other: conventional occupational therapy

VR treatment

EXPERIMENTAL

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

Interventions

conventional occupational therapy OTHER

upper limb exercises

Conventional intervention for upper limb reaching

video capture virtual reality DEVICE

virtual reality delivered uppe limb exercises

VR treatment

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• other neurological or orthopaedic problems that may interfere with interpretation of results
• significant deficits in attention, constructional skills, neglect and apraxia
• shoulder subluxation, arm pain
• lack of endurance as judged by a physician
• undergoing other therapy, surgery or medical procedures within the study period.
• \. Age 40-80 years
• \. any neurological or orthopaedic problems that may interfere with interpretation of results.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Ministry of Health, Israel: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 12, 2011
• First Posted: July 6, 2011
• Study Start: May 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

IL (1)