Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The overall objective of this research project is to examine the clinical efficacy of lower
      extremity cycling with functional electrical stimulation to improve the health and fitness of
      children with spinal cord injuries (SCI). To achieve this goal, a controlled, randomized
      study will be conducted with thirty children who have sustained a spinal cord injury. The
      children in the study will be assigned to one of three groups: those receiving functional
      electrical stimulation (FES) leg cycling exercise, those receiving passive leg cycling, and a
      non-cycling control group receiving electrical stimulation therapy to generate muscle
      contractions in the lower extremity. All three groups will be balanced as to the amount of
      time they receive the specific therapy. All therapies, after initial assessment, will be
      conducted at home in order to foster changes in lifestyle that may prove to be essential for
      improved quality of life.

      The specific aims of this proposal are delineated below:

      Aim 1: To assess, by means of a randomized controlled study design, the ability of FES
      cycling to improve the cardiovascular and musculoskeletal systems of ten children with a
      spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and
      ten children receiving electrical stimulation therapy alone.

      Aim 2: To determine, by means of a randomized controlled study design, the feasibility of
      using FES leg cycling exercise to provide long-term health benefits and improve the
      neurologic status of ten children with a spinal cord injury, as compared to ten children
      undergoing passive leg cycling exercise and ten children receiving electrical stimulation
      therapy alone.
    

Detailed description: 
      This is a controlled, randomized pretest/posttest study design in which three conditions will
      be compared: FES leg cycling exercise, passive leg cycling exercise, and a control group
      receiving electrical stimulation therapy. Randomization of the subjects into the three groups
      will be coordinated across the two sites. All other variables will be controlled to the
      extent possible. All children in this study will continue to receive standard therapy at the
      level established by the therapist working with the child. This includes passive stretching
      of the lower extremities and the use of standing frames. Medications will also remain
      unaltered throughout the study, unless changes in body mass or other physical conditions
      unrelated to the study (i.e. growth) warrant modification. All exercise sessions, after the
      initial one or two-week assessment, will be conducted at home.

      Electrical activation of the muscles in this study will be achieved through the use of
      surface mounted electrodes. The muscle groups that will be electrically activated in this
      study are the quadriceps, the hamstrings, and the gluteal muscles bilaterally. This is based
      upon the previous FES cycling studies conducted in the adult population. The appropriate
      stimulation levels for each muscle will be determined for each subject.

      All subjects in the three study groups, in addition to participation in this study, will
      receive standard therapy at home. For all of the children, this will include passive range of
      motion stretching three times each week. Ideally, stretching will be done before cycling or
      electrical stimulation therapy to act as a "warm-up" period before the more involved
      therapies are performed. For the children with sustained tetraplegia participating in this
      study, standard therapy will also involve standing three times each week, either with braces
      or the use of a standing frame.

      FES Cycling Group The FES cycling group will be asked to participate in additional therapy
      involving cycling for thirty minutes, three times a week. All cycling movements will be
      accomplished with electrical activation of the leg muscles. The first one to two weeks will
      be conducted on-site to monitor the subjects' reaction to exercise, after which therapy
      sessions will continue at home. The goal will be achieving thirty minutes of continuous
      cycling at 50 rev•min-1 with zero power output. Until subjects reach this point, the cycling
      session will be divided into five to ten minute-long sets, separated by five-minute rest
      breaks. Each subject, however, will complete a total of thirty minutes of cycling at the set
      speed. Once subjects reach this point, the power output requirements will be increased. From
      the zero point, the power requirement for the first session will be increased by one watt
      (W). If the subject can cycle continuously for 30 minutes, the next session the power output
      requirement will be increased by one watt. If the subject cannot pedal for a full 30 minutes,
      the power requirement will be maintained at this higher level until 30 minutes of continuous
      cycling can be achieved. The power requirement will then be increased by one watt on the next
      session. Increases will continue in this manner until the end of the protocol, or until the
      maximum power output of 50 watts, has been reached.

      Passive Cycling Group The passive cycling group will be asked to participate in additional
      therapy that will also involve cycling for thirty minutes, three times a week. However, the
      motor in the bicycle will provide all cycling movements. The first one to two weeks will be
      conducted on-site under the observation of the investigators, after which time therapy
      sessions will continue at home. The initial sessions will be used to determine whether the
      subject can tolerate the exercise, and to build fatigue resistance. The goal will be to
      achieve thirty minutes of continuous cycling at 50 rev•min-1 with zero power output. Once
      subjects can cycle for thirty minutes continuously, the subjects will continue at this level
      until the completion of the protocol.

      Electrical Stimulation Therapy Group Subjects in the control group will maintain their
      standard therapy, in addition to receiving additional electrical stimulation therapy of the
      quadriceps and hamstring muscles for a period of 30 minutes, three times per week. The
      children in this group will act as a control group for the comparison of additional therapy
      time involving cycling, as compared to additional therapy time only. Electrical stimulation
      was selected as the additional therapy of choice since specific health and physiologic
      benefits have already been reported by this group of investigators and could thus be seen as
      comparable to cycling. Stimulation of the muscles will be accomplished using a portable,
      2-channel surface stimulation unit (Empi, St. Paul Minnesota) instead of the ExoStim Unit.
      The hamstrings and quadriceps will be activated bilaterally for 15 minutes each at a level
      that produces a strong muscle contraction. This will be accomplished while the subjects are
      resting in the supine position, working against zero resistance. Attempts will also be made
      to incorporate the gluteal muscles into the electrical stimulation protocol, but the sessions
      will not exceed the thirty-minute time period.
    

Intervention name(s): FES Cycle; ES therapy; Passive (Motor Assist) Cycle
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will use electrical stimulation of the leg muscles to pedal a cycle for 1 hour / 3x week; Subjects will electrically stimulate the leg muscles for 1 hour/ 3x week; Subjects will use a cycle that moves the legs for 1 hour/3x per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment