Clinical trial NCT04306120: Effects of Thermal Stimulation on Motor Recovery and Neuromuscular Property of Lower Extremity in Stroke
Official title: Neurorehabilitation Lab at Department of Physical Therapy in KMU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Cardiovascular
Keywords: Thermal stimulation
Stroke
Spinal circuit
Motor function
Lower extremity
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Willing to participate to this study with written informed consent
2. First-ever stroke
3. More six months after stroke onset
4. Ability to maintain an independent sitting posture for at least 30 minutes
5. Mini Mental Status Examination score more than 24

Exclusion Criteria:

1. Skin disease, skin injuries, burns, or fresh scars over the thermal stimulation application area
2. Contraindication of ice or heat application
3. Uncontrolled blood pressure and heart conditions
4. History of diabetes with known peripheral vascular pathology
5. Pregnancy
6. Unable to communicate with simple instruction or aphasia
7. Receiving Botulinum toxin drug treatment
8. Considered as unsuitable by the principal investigator

Primary outcomes:
measure: The Lower Extremity subscale of Fugl-Meyer assessment (FMA-LE)
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
measure: The Postural Assessment Scale for Stroke (PASS)
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
measure: The modified Ashworth scale (MAS)
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
measure: The Barthel index (BI)
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
measure: Timed up and go test(TUG)
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
Secondary outcomes:
measure: Spinal circuit excitability
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
measure: Muscle properties
timeFrame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Kaohsiung Medical University Hospital
state: Select One...
Study officials:
affiliation: Department of Physical Therapy
name: Jau-Hong Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: