Development of Walk Assist Device to Improve Community Ambulation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Hypothesis/Specific Aims:

      The purpose of this study is to determine the effect of training with the Stride Management
      Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal
      drive to the lower limb muscles in patients post stroke. The investigators hypothesize that
      long-term SMA use would strengthen the connections between the motor areas of the brain and
      the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal
      excitability of the lower limb muscles compared to those in the IPT group.
    

Detailed description: 
      This is a randomized control trial comparing task specific training with the Stride
      Management Assist (SMA) device verses an impairment based physical therapy (IPT) approach on
      functional walking ability in outpatient stroke rehabilitation. Participants between the ages
      of 18-80 and who are 30 days or greater post stroke will be included.

      This SMA robotic device assists hip flexion and extension, for each side independently. It is
      controlled through software run on a tablet. The device weighs 2.8 kgs, and has 2 brushless
      direct current motors running on a rechargeable lithium ion battery. It comes in 3 sizes
      (small, medium and large). It is worn around like a belt with the motors near the hips and
      straps on the thighs. The SMA device allows users to increase their stride length by
      providing assist with the motors in flexion and extension. This device is 1) simple to use in
      the clinical setting; 2) easily adjustable to alter according to the requirements of each
      subject; and, 3) can quantify the amount of assistance required to facilitate walking
      patterns.

      Participants post stroke 30 days or greater will be recruited from inpatient, day
      rehabilitation and outpatient clinics. Participants will be scheduled for 18 Sessions of
      outpatient physical therapy plus 3 sessions of testing. The amount of sessions provided will
      be dependent upon compatibility with the device and ability to tolerate the device. A
      participant will continue with each session of the study as deemed appropriate by research
      staff.

        -  A. Phase I. (session 0): After consenting, subjects will undergo a physical evaluation
           and screening exam by a licensed physical therapist. If they meet study criteria, they
           will be randomly placed into either the SMA group or the IPT group using a random number
           generator and they will be entered into the study. Once they are enrolled, baseline
           outcome measures will be assessed by a blinded research physical therapist.

        -  B. Phase II. (sessions 1-9):

             -  Stride Management Assist Group: Treatment consists of 30 minutes high intensity
                gait training with device, 15 minutes functional mobility with device.

             -  Impairment Based Physical Therapy Group: Treatment will be divided into: 15 min
                balance training, 15 minutes functional mobility (transfers, strength or
                flexibility training) and 15 min high intensity gait training

        -  C. Phase III. (session 10): Mid treatment assessment. Outcome measures will be assessed
           by a blinded research physical therapist.

        -  D. Phase II. (sessions 11-19):

             -  Stride Management Assist Group: Treatment consists of 30 minutes high intensity
                gait training with device, 15 minutes functional mobility with device.

             -  Impairment Based Physical Therapy Group: Treatment will be divided into: 15 min
                balance training, 15 minutes functional mobility (transfers, strength or
                flexibility training) and 15 min high intensity gait training

        -  E. Phase IV. (session 20): Post Testing. Outcome measures will be assessed by a blinded
           research physical therapist.

      All testing and training sessions will be under the supervision of a licensed physical
      therapist. All subjects will be permitted to stop physical activity or rest at any time
      during the study. Adverse events will be recorded.

      The investigators anticipate this study will help determine if the Stride Management Assist
      is a practical option to better strengthen the connections between the brain and the lower
      limbs. The investigators do not foresee any potential pitfalls.
    

Intervention name(s): The Stride Management Assist (SMA) System; Impairment based therapy
Intervention type(s): Device; Other
Intervention description(s): Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.; Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The SMA group (task specific training) will be trained to simulate the demands of overground walking. The impairment based group will match the SMA group in intensity but will be focused on balance and other functional goals rather than explicitly on walking. The rationale of this study is to assess task specific training with SMA vs. impairment based training. To this end, we will use the Stride Management Assist device by Honda Corporation and compare it to impairment based physical therapy in outpatient sessions.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Gait; Stride Management Assist; Mild-moderate Stroke, post 30 days or longer