StrokeNCT07119632
Study of Medicine Stick Therapy Combined With Repeated Urotong Herapy on Lower Limb Dysfunction in Stroke Patients
A study testing RFE therapy in people with Stroke, run by Jiangen Ye.
Trial summary
At present, domestic scholars have applied medicine stick therapy and repetitive facial exercise (RFE) to the rehabilitation treatment of stroke patients, but there are few relevant literature reports on medicine stick therapy combined with RFE and show the differences in the effects of the two different treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- RFE therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke
- The first onset and the disease duration must be less than 3 months. exclusion criteria：
- Combined with other serious diseases such as severe cardiovascular, respiratory failure, liver and renal function damage, malignant tumors, etc.
- Consciousness disorders and cognitive impairment;
- Eczema, inflammation, infection, and scars at acupuncture points or skin;
Who cannot join
None listed.
About this study
Official title: Clinical Study Plan of Medicine Stick Therapy Combined With Repeated Urotong Therapy on Lower Limb Dysfunction in Patients With Stroke
At present, domestic scholars have applied medicine stick therapy and repetitive facial exercise (RFE) to the rehabilitation treatment of stroke patients, but there are few relevant literature reports on medicine stick therapy combined with RFE and show the differences in the effects of the two different treatment methods. To this end, this study intends to follow up the effects and effects of drug stick therapy and its combined effect with RFE on the recovery of lower limb motor function in patients after stroke, and follow up the patients' limb motor function, daily life activity ability, quality of life, balance function, etc.
Read the detailed description
At present, domestic scholars have applied medicine stick therapy and repetitive facial exercise (RFE) to the rehabilitation treatment of stroke patients, but there are few relevant literature reports on medicine stick therapy combined with RFE and show the differences in the effects of the two different treatment methods. To this end, this study intends to follow up the effects and effects of drug stick therapy and its combined effect with RFE on the recovery of lower limb motor function in patients after stroke, and follow up the patients' limb motor function, daily life activity ability, quality of life, balance function, etc.; use the Fugl-Meyer motor function evaluation scale, Barthel index, Brunnstrom grading, Holden walking function and other scales to conduct multi-angle evaluation of stroke patients, combine traditional Chinese medicine rehabilitation with Western medicine rehabilitation treatment, combine these two different treatment technologies, give full play to their respective advantages and integrated effects to verify. The specific research content includes: participant recruitment and screening, random grouping design, baseline evaluation, treatment intervention, post-treatment evaluation, data statistics and analysis. This study aims to explore the feasibility and advantages of the combined application of drug stick therapy combined with RFE to provide more effective treatment methods for rehabilitation of stroke patients.
- Conditions
- Stroke
- Being tested
- RFE therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFE therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Medication stick therapy +Repetitive facilitative exercise | Experimental | 1. Medication stick therapy:The specific operation is as follows: The patient lies down, holds the rods with both hands, and massages and squeezes the muscles from the muscle end towards the starting end while applying the medicinal wine. This causes the muscles to contract in a centripetal direction. The treatment is considered successful when there is local heat and the skin becomes flushed. It is performed 20 minutes per time, once a day, 6 times a week, for a total of 6 weeks.
2. Repetitive facilitative exercise: It includes specific movement patterns of the affected lower limb and weight-bearing training on the healthy side.Each movement pattern is performed 100 repetitions with the therapist's assistance, once a day, 6 days a week, for a total of 6 weeks of continuous treatment. Receives: Other: RFE therapy |
| Repetitive facilitative exercise | Active comparator | Repetitive facilitative exercise: It includes specific movement patterns of the affected lower limb and weight-bearing training on the healthy side.Each movement pattern is performed 100 repetitions with the therapist's assistance, once a day, 6 days a week, for a total of 6 weeks of continuous treatment. Receives: Other: RFE therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index
The Modified Barthel Index has a minimum score of 0 and a maximum score of 100. The higher the score, the better the functional ability.
Measured: From enrollment to 8 weeks of treatment
Secondary outcomes (1)
Holden Walking Function
Holden Walking Function: Minimum level 0, maximum level 6. The higher the level, the better the function.
Measured: From enrollment to 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangen Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiangen Ye, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119632
- Sponsor's protocol ID
- 2024B0564
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Plan of Medicine Stick Therapy Combined With Repeated Urotong Therapy on Lower Limb Dysfunction in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07119632
- Acronym / sponsor ID
- 2024B0564
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Jiangen YeUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 2025 (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.
At present, domestic scholars have applied medicine stick therapy and repetitive facial exercise (RFE) to the rehabilitation treatment of stroke patients, but there are few relevant literature reports on medicine stick therapy combined with RFE and show the differences in the effects of the two different treatment methods. To this end, this study intends to follow up the effects and effects of drug stick therapy and its combined effect with RFE on the recovery of lower limb motor function in patients after stroke, and follow up the patients' limb motor function, daily life activity ability, quality of life, balance function, etc.
Detailed description
At present, domestic scholars have applied medicine stick therapy and repetitive facial exercise (RFE) to the rehabilitation treatment of stroke patients, but there are few relevant literature reports on medicine stick therapy combined with RFE and show the differences in the effects of the two different treatment methods. To this end, this study intends to follow up the effects and effects of drug stick therapy and its combined effect with RFE on the recovery of lower limb motor function in patients after stroke, and follow up the patients' limb motor function, daily life activity ability, quality of life, balance function, etc.; use the Fugl-Meyer motor function evaluation scale, Barthel index, Brunnstrom grading, Holden walking function and other scales to conduct multi-angle evaluation of stroke patients, combine traditional Chinese medicine rehabilitation with Western medicine rehabilitation treatment, combine these two different treatment technologies, give full play to their respective advantages and integrated effects to verify. The specific research content includes: participant recruitment and screening, random grouping design, baseline evaluation, treatment intervention, post-treatment evaluation, data statistics and analysis. This study aims to explore the feasibility and advantages of the combined application of drug stick therapy combined with RFE to provide more effective treatment methods for rehabilitation of stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication stick therapy +Repetitive facilitative exercise | Experimental | Other: RFE therapy1. Medication stick therapy:The specific operation is as follows: The patient lies down, holds the rods with both hands, and massages and squeezes the muscles from the muscle end towards the starting end while applying the medicinal wine. This causes the muscles to contract in a centripetal direction. The treatment is considered successful when there is local heat and the skin becomes flushed. It is performed 20 minutes per time, once a day, 6 times a week, for a total of 6 weeks. 2. Repetitive facilitative exercise: It includes specific movement patterns of the affected lower limb and weight-bearing training on the healthy side.Each movement pattern is performed 100 repetitions with the therapist's assistance, once a day, 6 days a week, for a total of 6 weeks of continuous treatment. |
| Repetitive facilitative exercise | Active comparator | Other: RFE therapyRepetitive facilitative exercise: It includes specific movement patterns of the affected lower limb and weight-bearing training on the healthy side.Each movement pattern is performed 100 repetitions with the therapist's assistance, once a day, 6 days a week, for a total of 6 weeks of continuous treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of stroke
- The first onset and the disease duration must be less than 3 months. exclusion criteria：
- Combined with other serious diseases such as severe cardiovascular, respiratory failure, liver and renal function damage, malignant tumors, etc.
- Consciousness disorders and cognitive impairment;
- Eczema, inflammation, infection, and scars at acupuncture points or skin;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RFE therapy | Other | Medication stick therapy +Repetitive facilitative exercise, Repetitive facilitative exercise |
Primary outcome
Modified Barthel Index
Time frame: From enrollment to 8 weeks of treatment
The Modified Barthel Index has a minimum score of 0 and a maximum score of 100. The higher the score, the better the functional ability.
1 secondary outcome
Holden Walking Function
Time frame: From enrollment to 8 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing RFE therapy in people with Stroke, run by Jiangen Ye.
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 0 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: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Modified Barthel Index (time frame: From enrollment to 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2025.