Stroke, CardiovascularNCT04306120
Effects of Thermal Stimulation on Motor Recovery and Neuromuscular Property of Lower Extremity in Stroke
A study testing Traditional Rehabilitation Therapy in people with Stroke, Cardiovascular, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- Traditional Rehabilitation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Mar 2020to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Hospital
Kaohsiung City, Select One..., 886807
About this study
Official title: Neurorehabilitation Lab at Department of Physical Therapy in KMU
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.
Read the 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
- Being tested
- Traditional Rehabilitation Therapy
- Keywords
- Thermal stimulation, Stroke, Spinal circuit, Motor function, Lower extremity
- Medical subject headings
- Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Rehabilitation TherapyOther
The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.
| Study group | Role | What they receive |
|---|---|---|
| noxious cold group | Active comparator | The group received noxious cold (3 - 4°C) stimuli on the affected leg for 30 minutes. Receives: 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. Receives: 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. Receives: Other: Traditional Rehabilitation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Spinal circuit excitability will be assessed by measuring Hoffmann reflex/ M wave ratio of the soleus muscle. Higher scores indicate poorer outcome.
Measured: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
Muscle properties
Muscle properties will be evaluated by measuring the soleus muscle stiffness. Higher scores indicate poorer outcome.
Measured: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start9 Mar 2020
- Primary completion31 Jul 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KMUHIRB-F(II)-20200009, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jau-Hong Lin, PhD, Principal investigator, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306120
- Sponsor's protocol ID
- KMUHIRB-F(II)-20200009
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsiao SF, Huang YJ, Ke YT, Lo SK, Chen CH, Lin JH. Effects of noxious thermal stimulation on lower-limb motor function in chronic stroke: a randomized controlled trial with 1-month follow-up. Physiother Theory Pract. 2026 Apr 6:1-12. doi: 10.1080/09593985.2026.2647788. Online ahead of print.
PubMed 41943590
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurorehabilitation Lab at Department of Physical Therapy in KMU
- ClinicalTrials.gov ID
- NCT04306120
- Acronym / sponsor ID
- KMUHIRB-F(II)-20200009
- Conditions
- Stroke, Cardiovascular
- Keywords
- Thermal stimulation, Stroke, Spinal circuit, Motor function, Lower extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| noxious cold group | Active comparator | Other: Traditional Rehabilitation TherapyThe group received noxious cold (3 - 4°C) stimuli on the affected leg for 30 minutes. |
| noxious heat group | Active comparator | Other: Traditional Rehabilitation TherapyThe group received noxious heat (46 - 47°C) stimuli on the affected leg for 30 minutes. |
| alternative thermal stimulation group | Active comparator | Other: Traditional Rehabilitation TherapyThe group received alternative noxious heat (46 - 47°C) and noxious cold (3 - 4°C) stimuli on the affected leg for 30 minutes. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Rehabilitation TherapyThe protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability. | Other | alternative thermal stimulation group, noxious cold group, noxious heat group |
Primary outcome
The Lower Extremity subscale of Fugl-Meyer assessment (FMA-LE)
Time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
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.
The Postural Assessment Scale for Stroke (PASS)
Time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
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.
The modified Ashworth scale (MAS)
Time frame: 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 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.
The Barthel index (BI)
Time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
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.
Timed up and go test(TUG)
Time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
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.
2 secondary outcomes
Spinal circuit excitability
Time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
Muscle properties
Time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41943590Hsiao SF, Huang YJ, Ke YT, Lo SK, Chen CH, Lin JH. Effects of noxious thermal stimulation on lower-limb motor function in chronic stroke: a randomized controlled trial with 1-month follow-up. Physiother Theory Pract. 2026 Apr 6:1-12. doi: 10.1080/09593985.2026.2647788. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jau-Hong Lin, PhD principal investigator
Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Rehabilitation Therapy in people with Stroke, Cardiovascular, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Lower Extremity subscale of Fugl-Meyer assessment (FMA-LE) (time frame: Change from the beginning of the intervention to the end of the intervention, 1 month and 3 months after the intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04306120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.