Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format
Condition: Stroke; Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      Loss of arm use and strength are common problems after stroke that greatly affects
      independence in activities of daily living. Arm rehabilitation using robot-assisted
      repetitive task training has shown to improve motor recovery. However, this type of exercise
      cannot be done at home as these devices are large and expensive. This study will test whether
      a more portable, less costly, non-robotic repetitive training device called Bilateral Arm
      Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation
      format will lead to improvement in arm and hand use in patients with chronic stroke. The
      investigators plan to test the effectiveness of home based tele-rehabilitation with the
      BATRAC compared to a home and a clinic based approach.
    

Detailed description: 
      This is a longitudinal, single blind, randomized controlled trial with three parallel 6 week
      intervention arms that will be conducted over a three-year time period. After obtaining
      informed consent, and completing baseline testing, participants will be randomized to one of
      three study arms: 1) Home-based BATRAC Telerehab (HBT) + TTT, 2) Lab-based BATRAC (LBB) +
      TTT, and 3) Delayed Entry Usual Care. This delayed entry group will serve as a control for
      the initial six weeks of enrollment and NOT receive an active study intervention before
      randomizing to one of the two active interventions. Weekly phone calls will be conducted
      during this control period to record general activity (household or community) and monitor
      amount and intensity of arm use.

      Participants will complete Home-based BATRAC training or Lab-based BATRAC training three
      times a week for 6-9 weeks for a total of 18 training sessions. Participants will then be
      asked to return for a follow-up after 8 weeks of no training. A study evaluator blinded to
      the intervention assignment will complete all outcome measures at baseline, training
      completion, and at the 8 week retention follow-up. The participants in the Home-based BATRAC
      telerehabilitation group will be given a VA's MyHealtheVet (www.myhealth.va.gov) website
      account for asynchronous communication with the therapist and to access the educational
      features and resources about stroke, exercise and caregiver support. The interventions are as
      described below.

        1. Home-based BATRAC telerehabilitation: The BATRAC training platform will be used in
           conjunction with the VA MyHealtheVet website. This group will have a MyHealtheVet
           account to access the Secure Messaging Option for VA approved electronic messaging to
           the study therapist. The MyHealtheVet will provide asynchronous communication with the
           study therapist, and will store performance information entered by the participant and
           caregiver related to arm exercise duration, repetitions completed and distances reached.
           This account can be securely linked and is VA approved for use on any home device
           (computer, cell phone or tablet) with internet. MyHealtheVet training will be completed
           at the VA and at a one-time home visit with the participant and their identified
           caregiver to verify access, and use.

           BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest
           periods (see Lab-based BATRAC training details below) followed by 15 minutes of video
           guided Transition to Task Training (TTT). These videos will be linked from the VA
           MyHealtheVet site to study specific Youtube videos demonstrating the exercise. The
           initial training will occur in the lab setting with the therapist for BATRAC instruction
           and TTT exercise training. The participant and caregiver will have the opportunity ask
           questions and develop proficiency during this training session. For the TTT, each
           functional task will be presented via the MyHealtheVet Secure Messaging (SM) and linked
           by a URL to an instructive Youtube video clip of exercise sequencing, and level of
           difficulty. After completion of each exercise session the participant will complete a
           study report form attached to the SM. This information will be available for off-line
           assessment of performance by the research therapist. In cases of participant
           non-adherence, the therapist can contact the participant via phone to review exercise
           barriers and motivate the individual to participate. If necessary, the therapist could
           change the exercise parameters and send changes within the My HealtheVet SM.

        2. Lab-based BATRAC + TTT training: Participants randomized to this group will receive 60
           minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). The
           BATRAC training consists of high intensity bilateral reaching and retrieving (pushing
           handles away and pulling them back) on a constrained linear track to promote maximum arm
           extension. The track can be set at different angles in the work space. The training
           protocol is the same for both groups and will consist of four, 5-minute periods
           interspersed with 5-minute rest periods to avoid fatigue. An auditory metronome is set
           initially at the participant's preferred speed and for periods 1 and 3 participants move
           both arms simultaneously (in-phase). In periods 2 and 4 participants move both arms in
           alternating (antiphase) movements. A fifth bout of simultaneous arm movements will be
           included to reach the 45 minute training goal. Progression of the auditory cue
           frequency, direction of travel (pushing/pulling or in a diagonal) and distance of reach
           will be progressed every 2 weeks based on performance. If a progression cannot be
           sustained for the five-minute bouts by the end of the session, adjustments towards the
           previous level are made. This training will be followed by 15 minutes of transition to
           task training (TTT) as described below with supervision and support as needed by the
           therapist.

           Transition to Task Training (TTT): Each participant will receive 45 minutes of their
           randomized BATRAC intervention followed by 15 minutes of TTT. This training is
           functionally based in four domains of real-world tasks: homemaking, hygiene, feeding,
           and dressing. Two goal directed functional tasks are selected from the four domains
           every two weeks and prescribed to the individual based on severity level, general
           interests and goal. The task design is progressive in nature and difficulty is added by
           changing the parameters (movement amplitude) and demand (resistance) for increased
           generalization to real life challenges. Assist by the therapist or caregiver is provided
           to prevent compensatory movements from being re-enforced. For the home-based training,
           the caregiver will be instructed to provide this assistance through the initial personal
           training as well as have access to a set of videos for each of the tasks.

        3. Delayed Entry Usual Care: Participants randomized to this group will initially serve as
           a control and not receive any study interventions except for the protocol study
           evaluations in the same time intervals as those receiving active interventions and
           weekly phone calls to record general activity level. After serving as a control, this
           group will be entered into their delayed active intervention group of either lab-based
           BATRAC + TTT training, or Lab-based Robot+ TTT.
    

Intervention name(s): Home-Based BATRAC plus TTT; Lab-based BATRAC plus TTT; Delayed Entry Usual Care
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.; Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist.; Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel: participants are randomized to one of 3 groups: delayed control, active clinic-based training or active home-based training for the initial phase of the study. The delay group is randomly assigned to receive either clinic-based or home-based training for the second phase of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Motor Recovery; upper extremity