StrokeTSSPNCT01658293
Thermal Stimulation for Stroke Patients
A study testing thermal stimulation in people with Stroke and Upper Limb Paresis, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Upper Limb Paresis
- What is being tested?
- thermal stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2012to 31 Dec 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a first-time ischemic or hemorrhagic stroke.
- no severe diabetes or peripheral vascular disease causing sensory deficits.
- no cognition problem and follow directions indicated by therapist during experiment.
- motor deficit of the upper limb under (including) Brunnstrom stage IV, either in the arm or hand.
Who cannot join
- a cardiac disease or orthopedic problem history,
- medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facilitation of Sensory and Motor Recovery by Means of Heat and Cold-water Stimulation on the Paretic Upper Limb of After Stroke: One Year Follow up
Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. However, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. The aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.
Read the detailed description
Stroke patients from department of rehabilitation in Tzu Chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. In addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. The control group will be given ergometer exercises with the similar duration as experimental group. Both groups will be evaluated at baseline before TS and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A variety of evaluations used in the present study include Semmes-Weinstein monofilaments for sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were used for upper limb motor control and strength; Box and block test for hand dexterity. The modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor functions and daily activity performance, respectively. The modified Ashworth scale is used for change of muscle tone of upper limb.
- Conditions
- Stroke, Upper Limb Paresis
- Being tested
- thermal stimulation, control group ergometer exercises
- Keywords
- stroke, follow up, upper limb, rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal stimulationBehavioural
The heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks.
control group ergometer exercisesBehavioural
The control group will be given ergometer exercises with the similar duration as experimental group.
| Study group | Role | What they receive |
|---|---|---|
| thermal stimulation | Experimental | The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks. Receives: Behavioral: thermal stimulation |
| control group | Active comparator | The control group receiving the similar intensity of ergometer exercise as the experimental group. Receives: Behavioral: control group ergometer exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Scale for stroke upper limb recovery
The investigators will use the Fugl-Meyer Assessment Scale as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
Measured: one year
motricity index
The investigators will use the motricity index as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
Measured: one year
Secondary outcomes (3)
Semmes-Weinstein monofilaments for sensory functions
The investigators selected the Semmes-Weinstein monofilaments for sensory functions as our secondary outcome measures evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
Measured: one year
the modified motor assessment scale
The investigators used the modified motor assessment scale as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
Measured: one year
Barthel index
The investigators used the Barthel index as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study start1 Aug 2012
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
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 StrokeStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Ching Chen, Buddhist Tzu Chi General Hospital
- Investigators
- Jia-Ching Chen, master, Principal investigator, Tzu Chi Buddhist General Hospital, Hualien, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658293
- Sponsor's protocol ID
- IRB100-25
- Acronym
- TSSP
- Status last verified
- Jan 2022
- First submitted
- 1 Aug 2012
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiu YT, Liang CC, Yu Cheng H, Lin CH, Chen JC. Alternating Hot-Cold Water Immersion Facilitates Motor Function Recovery in the Paretic Upper Limb After Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Sep;105(9):1642-1648. doi: 10.1016/j.apmr.2024.05.008. Epub 2024 May 10.
PubMed 38734047
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation of Sensory and Motor Recovery by Means of Heat and Cold-water Stimulation on the Paretic Upper Limb of After Stroke: One Year Follow up
- ClinicalTrials.gov ID
- NCT01658293
- Acronym / sponsor ID
- TSSP / IRB100-25
- Conditions
- Stroke, Upper Limb Paresis
- Keywords
- stroke, follow up, upper limb, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 7 Aug 2012 (estimated)
- 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.
Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. However, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. The aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.
Detailed description
Stroke patients from department of rehabilitation in Tzu Chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. In addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. The control group will be given ergometer exercises with the similar duration as experimental group. Both groups will be evaluated at baseline before TS and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A variety of evaluations used in the present study include Semmes-Weinstein monofilaments for sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were used for upper limb motor control and strength; Box and block test for hand dexterity. The modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor functions and daily activity performance, respectively. The modified Ashworth scale is used for change of muscle tone of upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thermal stimulation | Experimental | Behavioral: thermal stimulationThe experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks. |
| control group | Active comparator | Behavioral: control group ergometer exercisesThe control group receiving the similar intensity of ergometer exercise as the experimental group. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a first-time ischemic or hemorrhagic stroke.
- no severe diabetes or peripheral vascular disease causing sensory deficits.
- no cognition problem and follow directions indicated by therapist during experiment.
- motor deficit of the upper limb under (including) Brunnstrom stage IV, either in the arm or hand.
Key exclusion criteria (2 listed)
- a cardiac disease or orthopedic problem history,
- medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.
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 |
|---|---|---|
| thermal stimulationThe heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks. | Behavioural | thermal stimulation |
| control group ergometer exercisesThe control group will be given ergometer exercises with the similar duration as experimental group. | Behavioural | control group |
Primary outcome
Fugl-Meyer Assessment Scale for stroke upper limb recovery
Time frame: one year
The investigators will use the Fugl-Meyer Assessment Scale as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
motricity index
Time frame: one year
The investigators will use the motricity index as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
3 secondary outcomes
Semmes-Weinstein monofilaments for sensory functions
Time frame: one year
the modified motor assessment scale
Time frame: one year
Barthel index
Time frame: one year
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 26 Jan 2022.
- Derived from this study: PubMed 38734047Chiu YT, Liang CC, Yu Cheng H, Lin CH, Chen JC. Alternating Hot-Cold Water Immersion Facilitates Motor Function Recovery in the Paretic Upper Limb After Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Sep;105(9):1642-1648. doi: 10.1016/j.apmr.2024.05.008. Epub 2024 May 10.
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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.
Jia-Ching Chen, master principal investigator
Tzu Chi Buddhist General Hospital, Hualien, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermal stimulation in people with Stroke and Upper Limb Paresis, run by Buddhist Tzu Chi General 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 4 inclusion and 2 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 26 Jan 2022. 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?
Fugl-Meyer Assessment Scale for stroke upper limb recovery (time frame: one year). The study lists 2 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 NCT01658293, 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 26 Jan 2022.