Improving Hand and Arm Function After Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The long-term goal of this project is to develop rehabilitation strategies that facilitate
      optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The
      objective of the studies proposed in this application is to determine whether a protocol of
      massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled
      hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these
      approaches are each more effective than traditional therapy (consisting of conventional
      resistance training; CRT).

      Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in
      skilled hand use and sensory function associated with either: massed practice training
      combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control
      (conventional resistance training [CRT]), and compare differences among groups. The
      investigators hypothesize that:

      H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor
      function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity
      Inventory) and sensory function (quantitative sensory tests; QST) will be greater in
      individuals who are trained using MP+SS compared to the SS and RT groups.

      H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor
      function and sensory function tests will be greater in individuals who are trained using SS
      compared to CRT.

      H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS
      groups.

      Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in
      cortical and spinal neurophysiology associated with either: massed practice combined with
      somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional
      resistance training [CRT]), and compare differences among groups. The investigators
      hypothesize that, after 4 weeks:

      H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential
      amplitude and location of cortical map) will show greater change in the direction of more
      normal values in individuals who are trained using MP+SS compared to the SS and the CRT
      groups.

      H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex
      amplitude) will show greater change in the direction of more normal values in individuals who
      are trained using SS compared to the MP+SS and the CRT groups.

      H2.3: There will be a positive relationship between change scores associated with functional
      outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there
      will be a positive relationship between change scores associated with the functional outcome
      measures and spinal neurophysiologic outcome measures in the SS group.

      Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in
      self-assessment of quality of life and societal participation associated with massed practice
      combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control
      (conventional resistance training [CRT]), and compare difference among groups. The
      investigators hypothesize that:

      H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study
      Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy
      Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to
      both the SS and the CRT groups.

      H3.2: Gains in scores on standardized measures of quality of life and societal participation
      will be greater in individuals who are trained using SS compared to the CRT group.

      H3.3: At 6 months post training, gains in the quality of life and the societal participation
      measures will be retained by the MP+SS and SS groups.

      Risks: This is a low risk study that investigates the effects of standard rehabilitation and
      exercise interventions on hand/arm function in individuals with SCI. All devices are
      considered minimal risk devices by the FDA.
    

Detailed description: 
      Evidence suggests that both intensive, skill-based practice training combined with
      somatosensory stimulation (MP+SS) and somatosensory stimulation alone (SS) may be associated
      with functional changes that are greater than those associated with skill-based training
      alone (MP). These studies are significant in that they advance the field of rehabilitation
      science as it relates to the goal of improving skilled hand use in individuals with SCI;
      there are few goals that have more important implications for function, independence and
      quality of life in these individuals.
    

Intervention name(s): Arm and hand training
Intervention type(s): Other
Intervention description(s): Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: task-specific training; arm and hand function; corticomotor plasticity; individuals with motor-incomplete spinal cord injury