Effects of Thermal Stimulation on Motor Recovery and Neuromuscular Property of Lower Extremity in Stroke
Condition: Stroke, Cardiovascular
MeSH terms: Stroke; Myocardial Infarction
Study type: Interventional

Summary: 
      This 3-year study will recruit a total of 72 subjects with first-ever stroke after 3 months
      onset from the department of Physical Medicine and Rehabilitation in 3 teaching hospitals.
      This study design employs a prospective single-blinded, randomized controlled trial with
      pretest, posttest, and follow-up assessments. Participants who meet and be willing to join
      this study will be assigned into one of three groups (noxious cold only, noxious heat only,
      or alternative TS). All subjects will receive conventional rehabilitation. In addition, three
      groups will receive an additional TS protocol with a total of 15 sessions for 3 weeks (5
      times per week, 30 minutes daily). Primary outcome measures include the LE subscale of
      Fugl-Meyer assessment, the modified Ashworth scale, the Postural Assessment Scale for Stroke
      Patients, Timed Up and Go test, and the Barthel index. Moreover, spinal circuit excitability
      will be assessed by measuring Hoffmann reflex/ M wave ratio, H-reflex recruitment curves, and
      reciprocal inhibition of the soleus muscle. Muscle properties will be evaluated by measuring
      the soleus muscle tone, elasticity, and stiffness. All participants will be assessed with the
      outcome measures at beginning of the intervention, the end of the intervention, 1 month and 3
      months after the intervention.
    

Detailed description: 
      Effective evaluation and treatment for lower extremity (LE) motor and function recovery in
      patients with stroke have been one of the primary goals for rehabilitation therapy. The
      purposes of this study are to compare immediate and long-term treatment effects among noxious
      cold only, noxious heat only, and alternative thermal stimulation (TS) on the LE motor
      recovery and neuromuscular properties and to investigate the relationships among spinal
      circuit excitability, muscle properties, and motor function of LE in patients with chronic
      stroke.

      This 3-year study will recruit a total of 72 subjects with first-ever stroke after 3 months
      onset from the department of Physical Medicine and Rehabilitation in 3 teaching hospitals.
      This study design employs a prospective single-blinded, randomized controlled trial with
      pretest, posttest, and follow-up assessments. Participants who meet and be willing to join
      this study will be assigned into one of three groups (noxious cold only, noxious heat only,
      or alternative TS). All subjects will receive conventional rehabilitation. In addition, three
      groups will receive an additional TS protocol with a total of 15 sessions for 3 weeks (5
      times per week, 30 minutes daily). Primary outcome measures include the LE subscale of
      Fugl-Meyer assessment, the modified Ashworth scale, the Postural Assessment Scale for Stroke
      Patients, Timed Up and Go test, and the Barthel index. Moreover, spinal circuit excitability
      will be assessed by measuring Hoffmann reflex/ M wave ratio, H-reflex recruitment curves, and
      reciprocal inhibition of the soleus muscle. Muscle properties will be evaluated by measuring
      the soleus muscle tone, elasticity, and stiffness. All participants will be assessed with the
      outcome measures at one week before the intervention, beginning of the intervention, the end
      of the intervention, 1 month and 3 months after the intervention. A two-way repeated measures
      analysis of variance will be used to investigate the effects among the three groups across
      time points tested with adequate post-hoc comparisons.

      The results of this study will help to understand the immediate and long-term effects of
      motor recovery of different TS modes and the adaptive change of neuromuscular properties as
      well to select the more effective TS treatment mode on facilitating LE motor and function
      recovery in patients with stroke.
    

Intervention name(s): Traditional Rehabilitation Therapy
Intervention type(s): Other
Intervention description(s): The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thermal stimulation; Stroke; Spinal circuit; Motor function; Lower extremity