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

NCT04306120 | Completed

• 1 other identifier: KMUHIRB-F(II)-20200009
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Cardiovascular

Keywords

Thermal stimulation; Stroke; Spinal circuit; Motor function; Lower extremity

Outcome Measures

Primary Outcomes (5)

• The Lower Extremity subscale of Fugl-Meyer assessment (FMA-LE)

  The FMA-LE consists of 17 items, each scored on a 3-point scale (0 to 2). The total score of the FMA-LE ranges from 0 to 34, and higher scores indicate better motor performance.

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

• The Postural Assessment Scale for Stroke (PASS)

  The PASS is a 4-point rating (0 to 3) scale with well-established reliability and validity that measures balance function in persons with stroke. The total score of the PASS ranges from 0 to 36, and higher scores indicate greater balance function.

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

• The modified Ashworth scale (MAS)

  The modified Ashworth scale is a 6-point rating scale (0 to 5) with well-established inter-rater reliability that measures muscle tone of ankle plantarflexor in persons with stroke. Higher MAS scores indicate greater severity of spasticity.

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

• The Barthel index (BI)

  The Barthel index is used to evaluate activity of daily living function.The Barthel index consists of 10 items. The total score of the Barthel index ranges from 0 to 20, and higher scores indicate better outcome.

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

• Timed up and go test(TUG)

  The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility.

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

Secondary Outcomes (2)

• Spinal circuit excitability

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

• Muscle properties

  Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.

Study Arms (3)

noxious cold group

ACTIVE COMPARATOR

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

Other: Traditional Rehabilitation Therapy

noxious heat group

ACTIVE COMPARATOR

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

Other: Traditional Rehabilitation Therapy

alternative thermal stimulation group

ACTIVE COMPARATOR

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

Other: Traditional Rehabilitation Therapy

Interventions

Traditional Rehabilitation Therapy 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; noxious cold group; noxious heat group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Select One..., 886807, Taiwan

Location

MeSH Terms

Conditions

Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jau-Hong Lin, PhD

  Department of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 12, 2020
• Study Start: March 9, 2020
• Primary Completion: July 31, 2023
• Study Completion: October 24, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)