Virtual Activities of Living for Occupational Rehabilitation

Criteria the registry did not label

• Criteria for inclusion:
• Participant has had a right or left hemispheric stroke affecting normal hand function.
• At least 3 months have passed since the last stroke.
• Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist.
• Participant has visual acuity with corrective lenses of 20/50 or better.
• Participant must have active movement against gravity of at least 30 degrees shoulder flexion, 45 degrees elbow flexion, elbow extension to within 30 degrees of full extension, and 15 degrees shoulder internal and external rotation.
• In the opinion of a study therapist, participant can independently and safely use the system at home or has an at-home caregiver who is willing and able to assist.
• In the opinion of a study therapist, participant has a suitable and safe space in their home for using the VALOR system.
• Participant is willing and able to provide informed consent.
  • Criteria for exclusion:
• Withholding or withdrawal of consent by the participant.
• Inability to understand and follow verbal directions.
• Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain.
• A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate).
• Determination by the Principal Investigator that participation would result in significant agitation or elevated stress.
• Visual field deficit in either eye that impairs the ability to view the VR display.
• Significant contractures of the muscles, joints, tendons, ligaments, or skin that restrict normal upper extremity movement.
• More than mild tone/spasticity (measured on modified Ashworth, 5-point scale);
• Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance.
• Severe sensory deficits from the involved UE; or
• Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the VR display.
  • As the system will be adaptable to a wide range of hand dexterity, no restriction will be made for fine control of digits. Patients will not be excluded due to inability to use the VR headset. If at any time the study therapist, in consultation with the Duke PI, determines the patient is not tolerating VR headset use, the patient will be given the option to use a non-immersive version of the VALOR system which employs a TV monitor and depth sensor in lieu of the headset. Please see Potential Risks section for additional details on controls and mitigations for potential cyber sickness.