Robot Aided Rehabilitation - Intervention "Aim2&3"

Not yet recruiting

Phase N/A Results N/A

Trial Description

Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.

Detailed Description

Sensorimotor impairments following stroke can lead to substantial disability involving the upper extremity. These impairments often involve complex pathological changes across multiple joints and multiple degrees-of-freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. Many potential mechanisms, such as weakness, motoneuronal hyperexcitability, and elevated passive impedance, can contribute and it is currently unclear where to focus treatment. The objectives of this study are to address allocation of therapy resources between the arm and hand and to examine the benefits of combining passive stretching with active movement training.
Aim 1. To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation.
Hypothesis 1: Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone.
Aim 2. To examine the efficacy of combining passive stretching with active (assistive or resistive) training for the shoulder, elbow, wrist, and hand.
Hypothesis 2: Multi-joint intelligent stretching followed by active (assistive or resistive) movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone.
Subjects will be assigned randomly with equal chance to one of four groups. Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Half of all the subjects will be assigned to the stretching groups and the other half to the passive movement groups. Half of the subjects will be assigned to the arm-training and the remaining half to hand-training groups. Arm-training groups will use the IntelliArm, hand-training groups will use the hand robot. For those assigned to the stretching groups, subjects will complete up to 30 minutes of passive stretching with the IntelliArm or the hand robot. For those assigned to the passive movement condition, subjects will do the robot according to their group assignment and wear it for up to 30 minutes with little to no stretching preceding the active therapy session. For each group, the initial about 30 minutes of stretching or relaxing will be followed by 45-60 minutes of active therapy with the IntelliArm or hand robot (depending on group assignment), for a total session time of 75-90 minutes.
The 4 groups of subjects will be compared against each other.

Conditions

Interventions

  • Stretching Other
    Intervention Desc: Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.
    ARM 1: Kind: Experimental
    Label: IntelliArm with stretching
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of passive stretching, then followed by 45-60 minutes of active therapy with the IntelliArm.
    ARM 2: Kind: Experimental
    Label: The hand robot with stretching
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of passive stretching, then followed by 45-60 minutes of active therapy with the hand robot.
  • Arm Other
    Other Names: IntelliArm
    Intervention Desc: During the hour of Active Training the subject will actively move their arm while supported in the IntelliArm to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
    ARM 1: Kind: Experimental
    Label: Passive Stretching
    Description: Subject receives passive stretching for 30 minutes prior to 1 hour of active therapy with either the IntelliArm or the X-Glove (depending on assigned intervention group).
    ARM 2: Kind: Experimental
    Label: No Stretching
    Description: Subject dons either the IntelliArm or X-Glove (depending on assigned intervention group) and rests for 30 minutes prior to 1 hour of active therapy using their assigned robot.
  • Hand Other
    Other Names: X-Glove
    Intervention Desc: During the hour of active training the subject will actively open and close their hand while participating in task oriented occupational therapy focused on grasp and release tasks.
    ARM 1: Kind: Experimental
    Label: Passive Stretching
    Description: Subject receives passive stretching for 30 minutes prior to 1 hour of active therapy with either the IntelliArm or the X-Glove (depending on assigned intervention group).
    ARM 2: Kind: Experimental
    Label: No Stretching
    Description: Subject dons either the IntelliArm or X-Glove (depending on assigned intervention group) and rests for 30 minutes prior to 1 hour of active therapy using their assigned robot.
  • Arm and Hand Other
    Other Names: IntelliArm and X-Glove
    Intervention Desc: Each visit subject alternates between interventions (a) and (b): During the hour of Active Training the subject will actively move their arm while supported in the IntelliArm to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance During the hour of active training, the subject will actively open and close their hand while participating in task oriented occupational therapy focused on grasp and release tasks.
    ARM 1: Kind: Experimental
    Label: Passive Stretching
    Description: Subject receives passive stretching for 30 minutes prior to 1 hour of active therapy with either the IntelliArm or the X-Glove (depending on assigned intervention group).
    ARM 2: Kind: Experimental
    Label: No Stretching
    Description: Subject dons either the IntelliArm or X-Glove (depending on assigned intervention group) and rests for 30 minutes prior to 1 hour of active therapy using their assigned robot.
  • Arm with Sham Stretching Other
    Other Names: IntelliArm
    Intervention Desc: During the hour of Active Training the subject will actively move their arm while supported in the IntelliArm to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance. Subjects will spend the 15 minutes prior to active training In the IntelliArm with it on and moving their arm only within ranges that produce no to very minimal forces.
    ARM 1: Kind: Experimental
    Label: Sham Stretching
    Description: Subject dons either the IntelliArm or X-Glove (depending on assigned intervention group) and is stretched minimally by the robot for 15 minutes prior to 45 minutes of active therapy using their assigned robot. Movement is limited to ranges where no or minimal force is produced.
  • Hand with Sham Stretching Other
    Other Names: X-Glove
    Intervention Desc: During the hour of active training the subject will actively open and close their hand while participating in task oriented occupational therapy focused on grasp and release tasks. Subjects will spend the 15 minutes prior to active training with the X-Glove on and moving their hand only within ranges that produce no to very minimal forces.
    ARM 1: Kind: Experimental
    Label: Sham Stretching
    Description: Subject dons either the IntelliArm or X-Glove (depending on assigned intervention group) and is stretched minimally by the robot for 15 minutes prior to 45 minutes of active therapy using their assigned robot. Movement is limited to ranges where no or minimal force is produced.
  • Arm and Hand with Sham Stretching Other
    Other Names: IntelliArm and X-Glove
    Intervention Desc: Each visit subject alternates between interventions (a) and (b): During the hour of Active Training the subject will actively move their arm while supported in the IntelliArm to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance During the hour of active training, the subject will actively open and close their hand while participating in task oriented occupational therapy focused on grasp and release tasks. In both treatments A and B, subjects will spend 15 minutes prior to active training with the IntelliArm or X-Glove moving their arm or hand (respectively) only within ranges that produce no to very minimal forces.
    ARM 1: Kind: Experimental
    Label: Sham Stretching
    Description: Subject dons either the IntelliArm or X-Glove (depending on assigned intervention group) and is stretched minimally by the robot for 15 minutes prior to 45 minutes of active therapy using their assigned robot. Movement is limited to ranges where no or minimal force is produced.
  • Arm with Stretching Other
    Intervention Desc: During the hour of Active Training the subject will actively move their arm while supported in the IntelliArm to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
    ARM 1: Kind: Experimental
    Label: Passive Stretching
    Description: Subject receives passive stretching for 15 minutes prior to 45 minutes of active therapy with either the IntelliArm or the X-Glove (depending on assigned intervention group).
  • Hand with Stretching Other
    Intervention Desc: During the hour of active training the subject will actively open and close their hand while participating in task oriented occupational therapy focused on grasp and release tasks. Subjects will spend the 15 minutes prior to active training In the IntelliArm with it on and moving their arm within maximum tolerable ranges without pain or compensatory movements.
    ARM 1: Kind: Experimental
    Label: Passive Stretching
    Description: Subject receives passive stretching for 15 minutes prior to 45 minutes of active therapy with either the IntelliArm or the X-Glove (depending on assigned intervention group).
  • Arm and Hand with Stretching Other
    Intervention Desc: Each visit subject alternates between interventions (a) and (b): During the hour of Active Training the subject will actively move their arm while supported in the IntelliArm to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance During the hour of active training, the subject will actively open and close their hand while participating in task oriented occupational therapy focused on grasp and release tasks. In both treatments A and B, subjects will spend 15 minutes prior to active training with the IntelliArm or X-Glove moving their arm or hand within maximum tolerable ranges without pain or compensatory movements.
    ARM 1: Kind: Experimental
    Label: Passive Stretching
    Description: Subject receives passive stretching for 15 minutes prior to 45 minutes of active therapy with either the IntelliArm or the X-Glove (depending on assigned intervention group).
  • Passive movement Other
    Intervention Desc: Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces.
    ARM 1: Kind: Experimental
    Label: IntelliArm with passive movement
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with little to no stretching, then followed by 45-60 minutes of active therapy with the IntelliArm.
    ARM 2: Kind: Experimental
    Label: The hand robot with passive movement
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with little to no stretching, then followed by 45-60 minutes of active therapy with the hand robot.
  • IntelliArm Other
    Intervention Desc: During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
    ARM 1: Kind: Experimental
    Label: IntelliArm with stretching
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of passive stretching, then followed by 45-60 minutes of active therapy with the IntelliArm.
    ARM 2: Kind: Experimental
    Label: IntelliArm with passive movement
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with little to no stretching, then followed by 45-60 minutes of active therapy with the IntelliArm.
  • Hand robot Other
    Intervention Desc: During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.
    ARM 1: Kind: Experimental
    Label: The hand robot with stretching
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of passive stretching, then followed by 45-60 minutes of active therapy with the hand robot.
    ARM 2: Kind: Experimental
    Label: The hand robot with passive movement
    Description: Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with little to no stretching, then followed by 45-60 minutes of active therapy with the hand robot.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity (FMUE) - Pre Within 1 week prior to intervention No
Primary Fugl-Meyer Upper Extremity (FMUE) - Post Within 1 week following intervention No
Primary Fugl-Meyer Upper Extremity (FMUE) - Follow-Up 2 months following intervention No
Secondary Graded Wolf Motor Function Test (GWMFT) - Pre Within 1 week prior to intervention No
Secondary Graded Wolf Motor Function Test (GWMFT) - Post Within 1 week following intervention No
Secondary Graded Wolf Motor Function Test (GWMFT) - Follow-Up 2 months following intervention No
Secondary Action Research Arm Test (ARAT) - Pre Within 1 week prior to intervention No
Secondary Action Research Arm Test (ARAT) - Post Within 1 week following intervention No
Secondary Action Research Arm Test (ARAT) - Follow-Up 2 months following intervention No
Secondary Stiffness - Pre Within 1 week prior to intervention No
Secondary Stiffness - Post Within 1 week following intervention No
Secondary Stiffness - Follow-Up 2 months following intervention No
Secondary Active Range of Motion (AROM) - Pre Within 1 week prior to intervention No
Secondary Active Range of Motion (AROM) - Post Within 1 week following intervention No
Secondary Active Range of Motion (AROM) - Follow-Up 2 months following intervention No
Secondary Strength - Pre Within 1 week prior to intervention No
Secondary Strength - Post Within 1 week following intervention No
Secondary Arm Strength - Follow-Up 2 months following intervention No
Secondary Stiffness - Pre Within 1 week prior to intervention No
Secondary Stiffness - Post Within 1 week following intervention No
Secondary Active Range of Motion (AROM) - Pre Within 1 week prior to intervention No
Secondary Strength - Post Within 1 week following intervention No
Primary Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
Secondary Changes from baseline Fugl-Meyer Upper Extremity at two time points Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
Secondary Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline Modified Ashworth Scale (MAS) at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline Action Research Arm Test (ARAT) at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline Grip Strength & Pinch Strength at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline Nottingham Sensory Assessment at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline range of motion (ROM) at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline spasticity at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Secondary Changes from baseline relaxation time of the finger flexor muscles at two time points Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

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