Locomotor Training (Walking Therapy) Post Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This is a research study to examine a new type of walking therapy for people after they have
      had a stroke. We will study how people move and how their muscles work to see how the therapy
      helps people to walk better and to see how the therapy can be improved.
    

Detailed description: 
      Persons will be asked to walk indoors on a walkway at their own speed and then as fast as
      they can safely. The walkway measures the speed of their walking and the size of their steps.
      Participants can use any assistive device that they typically use. A physical therapist will
      walk beside them as they walk across the walkway. Participants will be asked to walk several
      times across the walkway for distances of approximately 20 feet each time. If persons meet
      all the study requirements, they will be scheduled for further testing and for the training.
      We will contact their physician and inform him/her of their interest in participating in this
      study and the study criteria for participation. We will need to receive their physician's
      written medical approval for their participation in this study before we begin the training.

      Persons will first have an exercise tolerance test to make sure that it is safe for them to
      participate in the exercise program that is a part of this study. In the exercise test, they
      will be asked to ride a stationary bicycle at a specific speed while a cardiologist (a doctor
      who specializes in testing how well the heart works) or a nurse practitioner with a PhD who
      specializes in cardiology will monitor their heart rate, blood pressure, the EKG (the
      electrical signals produced by their heart). The cardiologist or nurse practitioner will
      conduct, supervise, and interpret findings for the exercise tolerance test. Every minute, the
      resistance of the bicycle will be increased until their heart rate rises to a certain level.
      The test will be stopped immediately if they have any atypical or abnormal reactions to the
      test. If the test has to be stopped for these reasons, we will refer them back to their
      doctor, and they will not be able to participate in the study. A therapist or research
      assistant will assist them on and off the bicycle and be sure that they are comfortable.

      Clinical Testing. We will first evaluate the severity of their stroke and the effects of
      their stroke on their ability to move their arms and their legs. Next we will test their
      walking speed, their balance, their strength, and how much they walk over a typical 4-day
      period. We will repeat the clinical tests after completion of training, and again 6 months
      after they finish their training.

      Walking Testing: Persons will be asked to wear shorts and low-heeled walking shoes (tennis
      shoes preferred). Small, dime-sized light-reflecting markers will be placed on their head,
      shoulder, arm, hand, trunk, hip, knee, ankle, and foot to study and assist in recording the
      position of their joints while moving. They may be asked to have their muscle activity and
      leg motions recorded while they walk overground and on the treadmill. For the walking
      testing, we may need to shave small areas of their legs to attach small sensors to their skin
      to record activity of their leg muscles. We may also attach small angle measurement devices
      to the skin over their hips, knee, or ankle joints on their legs. We will film their walking
      with video cameras. When they are walking, a therapist will guard them or assist as
      necessary.

      They will be asked to begin walking over 1) treadmill and 2) overground at their comfortable
      speed and as fast as possible. During all treadmill walking, they will wear a harness
      attached to a mobile device attached to the ceiling. This harness is only used for their
      safety to prevent a fall (it will catch them should they lose their balance or stumble).
      However, it will not support any of their weight while they are walking. If they use braces
      and/or assistive devices, they may be asked to do some walking with and without them,
      according to their comfort and safety. A therapist will stand beside them to provide any
      physical assistance they may need.

      Persons may be asked to pedal a stationary bike while the muscle sensors are attached to
      them. If so, they will be assisted to sit on a stationary bike and their feet will be secured
      to the pedals. A trainer will monitor them and may assist them to move their legs.

      Persons will be asked to wear a small device on their leg, which will keep count of how many
      steps they take in the course of a day. The device is very safe, lightweight, and very small.
      We will show them how to use the device before them go home with it. This device may be taken
      off while them are bathing or sleeping and will need to be worn for 4 days at each test
      session. We will repeat the walking tests after completion of training, and again 6 months
      after them finish their training.

      There will also be weekly testing in the lab that is not as intensive.

      Metabolic Testing: This testing will be done 2 times, once at the start of their training
      sessions and once following the completion of their training sessions. They will be asked to
      wear a facemask, which will cover their nose and mouth, which is connected to a portable
      metabolic unit. A metabolic unit measures the oxygen they breathe in and the carbon dioxide
      they breathe out when they are walking. The metabolic unit also measures their respiration
      rate - that is how many breaths they take during every minute. Their heart rate will be
      measured by a wireless heart monitor while they are walking. Persons may be asked to wear the
      facemask while they walk over the indoor walkway mentioned above. They may also be asked to
      wear the mask while they walk for six minutes.

      Immediately after they finish a walk they may be asked to show how hard they feel they worked
      during the walk by pointing to a chart numbered 6 to 20 with short phrases such as very
      light, somewhat hard, etc, next to the numbers. This chart will be explained to them before
      they start walking.

      Currently the metabolic testing is not performed during typical inpatient or outpatient
      rehabilitation.

      Training: Persons will train 3 times a week for 12 weeks. The training sessions will each
      last about an hour to an hour and a half. Times of their therapy will be coordinated with
      their trainer, who will be either a licensed physical or occupational therapist. The
      therapist will monitor their heart rate and blood pressure during their training and will
      stop the therapy session if necessary should their heart rate or blood pressure exceed normal
      limits for them. Persons may ask for as many rest breaks as you need during testing or
      training.

      For the treadmill training, they will wear a vest like a rock-climbing harness, which is then
      attached to a device to help you support your weight. A safety support is also attached to
      you to make sure that you cannot fall to the ground. The therapists working with you will
      help them take steps on the treadmill, trying to help their walking be as close to normal as
      possible.

      Participants will also be asked to walk overground when they get off the treadmill. Their
      walking therapy may include walking in different settings (for example, outside or inside),
      choosing the appropriate assistive device, examining for the need for leg braces, training
      for balance and endurance, and using the same skills that they are learning on the treadmill
      while walking overground in their home and community. During their overground training, they
      may be asked to walk across the walkway to measure their speed.

      Participants may be asked to answer some questions about how they feel about the training; if
      it has helped them, how it has helped; what the training was like for them; or ways to
      improve the training. These interviews may be documented by written record and/or by
      audiotape recording. Also, some of their training sessions may be observed by a person who
      may make notes on how the training is going, how the therapist(s) are working with them and
      any important comments they or the trainers make about the training sessions.
    

Intervention name(s): locomotor training
Intervention type(s): Behavioral
Intervention description(s): Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment