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

NCT ID: NCT04306120

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2023-10-24

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.

Conditions

Stroke, Cardiovascular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

noxious cold group

The group received noxious cold (3 - 4°C) stimuli on the affected leg for 30 minutes.

Group Type: ACTIVE_COMPARATOR

Traditional Rehabilitation Therapy

Intervention Type: OTHER

The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.

noxious heat group

The group received noxious heat (46 - 47°C) stimuli on the affected leg for 30 minutes.

Group Type: ACTIVE_COMPARATOR

Traditional Rehabilitation Therapy

Intervention Type: OTHER

The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.

alternative thermal stimulation group

The group received alternative noxious heat (46 - 47°C) and noxious cold (3 - 4°C) stimuli on the affected leg for 30 minutes.

Group Type: ACTIVE_COMPARATOR

Traditional Rehabilitation Therapy

Intervention Type: OTHER

The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

KMUHIRB-F(II)-20200009

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jau-Hong Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, Select One..., Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(II)-20200009

Identifier Type: -

Identifier Source: org_study_id