Robot Aided Rehabilitation - Intervention "RAR2"

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to address the allocation of therapy resources between the arm and the hand as well as to examine the benefits of combining passive stretching with active movement training.

Detailed Description

Aim 1 and Hypothesis 1 are included in a separate submission and will not be included in this protocol and consent
Aim 2. To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation.
Hypothesis 2: Combining treatment of the arm and hand, even at the cost of decreasing the total amount of time which can be spent on either, will lead to greater improvement than focusing primarily on the arm or on the hand alone.
Aim 3. To examine the efficacy of combining passive stretching with active-assistive (resistive training for the shoulder, elbow, wrist, and hand.
Hypothesis 3: Multi-joint intelligent stretching followed by active (assistive or resistive) movement facilitated by use of the IntelliArm and X-Glove will improve motor control of the upper extremity more than standard movement therapy alone.
BACKGROUND AND SIGNIFICANCE
Stoke is the leading cause of adult disability and the third leading cause of death (killing 160,000 Americans/year) in the United States; about 750,000 first ever and recurrent strokes occur in the United States each year. The economic burden is huge with estimated costs for medical expenses and lost wages totaling $62.7 billion in the U.S. Stroke is commonly associated with motor-related disabilities, typically affecting the shoulder, elbow, wrist, and fingers of the arm simultaneously. Patients may develop spastic hypertonia and reduced range of motion (ROM) at multiple joints. Several stereotypical patterns of arm impairment with multiple joints involved are commonly seen in stroke survivors, including adducted/internally rotated shoulder, flexed elbow, pronated forearm, flexed wrist, and clenched fist. Furthermore, impaired arms of stroke survivors commonly develop abnormal coupling among the multiple joints and among the multiple DOFs (e.g. shoulder abduction, flexion, and rotation) at a given joint. Stroke survivors may exhibit a limited capacity to create independent movements of individual joints or to coordinate the activity of multiple joints. There is a strong need to treat this hypertonia, involuntary coactivation, and poor coordination on a frequent basis to reduce spasticity/contracture and increase mobility in those who have had a stroke. This is the goal of the proposed study.
METHODS Aims 2 and 3 will be addressed through a longitudinal intervention trial. Outcomes data for each subject will be collected at multiple time points during the study. Specifically, evaluation sessions will be conducted one time before the initiation of therapy (Pre-Treatment Evaluation) one time within after the conclusion of therapy (Post-Treatment Evaluation), and two months later (Follow-up Evaluation).
Selection of Subjects 72 subacute stroke survivors will be recruited according to the inclusion and exclusion criteria listed over 5 years.
Intervention Each subject will complete 18 therapy sessions over 6 weeks, in addition to 6 evaluation sessions and 1 screening session. Subjects will be assigned evenly to one of six groups. Groups are split into 2 conditions based on stretching and 3 conditions based on target of intervention (arm, hand, or both arm and hand). Half of the 72 subjects will be assigned to the stretching groups and the other half to the sham stretching groups. One third of the subjects will be assigned to each of the arm-alone, hand-alone, and arm-and-hand conditions. Arm-alone groups will use the IntelliArm, hand-alone groups will use the X-Glove, and arm-and-hand groups will use both the IntelliArm and the X-Glove by alternating sessions with each robot (9 sessions with the IntelliArm, 9 sessions with the X-Glove). For those assigned to the stretching groups, subjects will complete 15 minutes of passive stretching with the IntelliArm or X-Glove. For those assigned to the sham-stretching condition, subjects will don the robot according to their group assignment and wear it for 15 minutes preceding the active therapy session while the robot moves their arm or hand in ranges where very minimal force is produced. For each group, the initial 15 minutes of stretching or relaxing will be followed by approximately 45 minutes of active therapy with the IntelliArm or X-Glove (depending on group assignment), for a total session time of about 60 minutes.
The subjects participating in Aims 2 and 3 will be asked to come to our labs at the Rehabilitation Institute of Chicago to provide informed consent and then complete a screening, which will take approximately 30 minutes and include a basic questionnaire and some clinical evaluations. If qualified and enrolled, subjects will complete 5 evaluation sessions and 22 training sessions.
Training
The training in this study will last for 6 weeks with about 3 visits per week for 18 sessions in total. At the beginning of each training session, the subject will be asked about any muscle or joint soreness in the hemiparetic arm and hand since the last session. If the subject has persistent or severe pain, he/she will not continue until he/she feels sufficiently recovered and the clinician agrees.
IntelliArm Training During the training, the subject will sit upright on a barber's chair with his/her trunk strapped to the backrest of the chair. The subject's arm, forearm and hand will be strapped to braces that are connected to a robotic arm; adjustments will be made to customize the robotic arm for each subject. Once adjustments are completed, the training will begin, consisting of passive stretching (for half of the subjects) followed by active movement therapy. Each training session should last between one and one and a half hours.
In the stretching mode, the robotic arm will move the subject's shoulder, elbow and wrist. Sometimes these joints will be moved one at a time and sometimes they will be moved together. The joints/DOFs with excessive coupling and/or increased stiffness and the associated arm postures will be identified and will be targeted for particular attention. The IntelliArm will stretch the impaired arm under novel multi-joint intelligent control to stretch the joints forcefully and safely in well-coordinated patterns. On the one hand, for safe treatment, the stretching velocities will decrease with increased resistance torques at the multiple joints involved and each joint will be stretched according to its own condition and the condition of the coupled joints. On the other hand, for effective treatment, the stretching will not stop until pre-specified peak resistance torque is reached at the joints/DOFs involved. The stretched arm will be held at the extreme positions for a period of time to let stress relaxation occur before the joints are moved to other extreme positions.
In the active training mode, the subject will be asked to move the robotic arm around to interact with virtual targets and objects. For example, target points will be displayed and the subject will be asked to move the hand from the current position to the target, while matching the individual joints angles as well. A circle in the virtual hand needs to overlap the red-dot targets on the computer monitor for successful match. The IntelliArm can be made backdrivable by implementing zero-torque control with six-DOF force/torque sensors at each joint. Alternatively, assistance (or resistance) can be provided by the IntelliArm to the impaired arm during the voluntary movement in training to help subjects with arm impairments reach the target. The level of assistance will be adjusted depending on the severity of the impairment. Subjects will also move the IntelliArm in order to play computer games such as catching a baseball or football, and to transport virtual objects from one location to another in the display. As the user progresses in motor control capability, the workspace will be increased and resistance instead of assistance may be provided during the movement to make it more challenging to the patients.
X-Glove Training Two-thirds of the subjects will utilize the X-Glove in their therapy. This actuated glove provides independent extension force to each digit. Cables run from linear actuators located on the forearm through cable guides located on the back side of the digits to the fingertips (Fig. 3). A wrist splint keeps the wrist in the neutral position such that movement of the cable translates into corresponding movement of the digit. Force in each cable is measured with an in-line sensor, while cable position can be estimated from the motor displacement. As with the IntelliArm, the X-Glove will be operated in two modes, one of which will provide stretching while the other provides assistance for hand opening during active training. For subjects assigned to stretching groups, the X-Glove will first run in a mode that provides cyclic stretching at a rate of approximately 90 repetitions of passive range of motion over 30 minutes. The motors will move the digits from an initial flexed resting posture to the subject's extension limit, as determined by force sensors and range of motion limits set by the therapist daily. The subject will remain relaxed throughout the stretching period.
Evaluation and Measurement In an initial screening session, a clinician will check the subject's health status and conduct clinical examinations in order to determine if the subject fits the inclusion and exclusion criteria. During the screening session the subject will participate in several clinical assessments. The screening evaluations will take about one half hour.
For each evaluation session he/she will be asked to come to our laboratories on the 13th floor of the Rehabilitation Institute of Chicago. Evaluation of subjects will have neuromechanical and clinical components; both the neuromechanical and clinical components of evaluation will take approximately two hours and be split into two sessions which will both take place in the week before treatment.
Protection Against Risk:
A number of safeguards have been implemented. Mechanical/electrical stops will be used to restrict the motion of the robots to safe ranges. Velocity limits will also be set to restrict the speed of the movement. Joint angle, velocity, and force will be monitored continuously to ensure they fall within the appropriate range. Exceeding the thresholds will result in motor shut-down. Additionally, the motors can be turned off at any time using an accessible on/off switch to protect from discomfort or potential injuries. The IntelliArm and X-Glove have previously been used safely with a number of stroke survivors. Rest breaks will be provided as needed during therapy to prevent excessive muscle soreness and fatigue.
A cast saw will be used to remove the fiberglass cast used in evaluations. Improper use of the saw could produce a burn. Project staff has been trained in the operation of the saw and proper procedures to follow. Adhesive used to secure the surface electrode could irritate the skin. The skin will be carefully prepared before applying the electrode and then cleaned when the electrode is removed.
Specific to TMS, although rare instances of seizure have been reported when long trains of high frequency excitatory TMS were applied, these events have not been reported when recommended guidelines originally published in 1996 and updated by Rossi et al. 2009 Clin. Neurophysiol. 120:2008-2039, have been followed. The parameters proposed in this study are well within these published safety guidelines, and individuals who have suffered a stroke are one of the most commonly requited populations for TMS studies. Providing they have never had a seizure and do not meet any of the other exclusion criteria listed above, they are a clinical population to which TMS can be safely applied.
Data Analysis:
To relate and find the relationship between physiological data and functional performance the data will be evaluated using a) biomechanics data analysis, b) correlation and principle component analysis, c) regression, d) Rasch analysis, and e) structural equation modeling. Physiological data obtained from the IntelliArm (e.g. abnormal coupling of between the joints/DOFs, passive workspace and active workspace, multiple joint DOF/stiffness) will be analyzed to describe and characterize the arm impairment. The physiological data will also be compared to the therapist-rated data (WMFT, ARAT, CAHAI, FMUE) to investigate their relationship. To determine the proper physiological measurements in rehabilitation of stroke and relate them to functional performances, correlation analysis and principal component analysis will be conducted as initial steps to find which physiological variables have high correlations with functional measures and cluster together as similar indicators. Those potential indicators will be filters for a data reduction procedure. The selected data will then be used in a multiple regression analysis to predict functional outcomes at the activity level (assessed by WMFT, ARAT, and CAHAI) and participation level (assessed by the datalogger) with adjusted person information and environmental factors serving as categorical variables. Rasch analysis will be used to evaluate the item difficulty hierarchy and item fit to link subject's functional ability level with specific functional tasks, which allows us to find the clinical potential thresholds/cut-off points if there is a consistent pattern between exists the physiological data and functional measures. Furthermore, an ICF model will be evaluated using structural equation modeling, which can test a set of regression equations simultaneously and exam the relationship among the impairment ability, participation variables with the personal and environmental factors taken into consideration. Two months after the 22 sessions training, the subject will be asked to return to our lab for a follow-up evaluation. The same evaluations as described above will be done in this session. The subjects, who participated in the training, will fill out a form, which may be sent to them by email, about his/her health status and injury history three month after the training period to evaluated changes in performance in the hemiparetic arm.

Conditions

Interventions

  • 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).

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

Sponsors