NCT04306120

Effects of Thermal Stimulation on Motor Recovery and Neuromuscular Property of Lower Extremity in Stroke

Neurorehabilitation Lab at Department of Physical Therapy in KMU

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Cardiovascular

Interventions

Type	Name	Description
OTHER	Traditional Rehabilitation Therapy	The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.

Timeline

• Start date: 2020-03-09
• Primary completion: 2023-07-31
• Completion: 2023-10-24
• First posted: 2020-03-12
• Last updated: 2023-11-18

Locations

1 site across 1 country: Taiwan