Hemiplegia and/or Hemiparesis Following StrokeNCT06461013
The Effect of Blood Flow Restriction Training on Lower Limb Motor Function in Stroke Patients With Hemiplegia
A study testing Blood flow restriction in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Yunhong Tian at 1 site in China.
Trial summary
flow restriction training combined with routine rehabilitation training can promote the recovery of lower limb muscle strength on the hemiplegic side of stroke patients, improve the lower limb motor function of patients, and further improve their daily life and walking ability. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- Blood flow restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 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 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The diagnosis of stroke meets the diagnostic criteria revised by the Fourth National
- Conference on Cerebrovascular Diseases
- Confirmed by cranial CT and/or MRI
- First onset, hemiplegia of one limb, clear consciousness, stable vital signs, no serious complications such as heart, lung, kidney, etc., no serious cognitive or audio-visual impairment
Who cannot join
- Uncontrolled hypertension
- Coronary artery disease
- Uncontrolled autonomic reflex abnormalities
- Severe spasms
- History of fractures or fractures
- Deep vein thrombosis
- Cognitive impairment, inability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
flow restriction training combined with routine rehabilitation training can promote the recovery of lower limb muscle strength on the hemiplegic side of stroke patients, improve the lower limb motor function of patients, and further improve their daily life and walking ability. It provides a new treatment method for stroke patients with hemiplegia that leads to lower limb function loss and activity disorder, and the therapy also has the advantages of simple operation, high safety, good patient compliance and low cost, which is worthy of further clinical research and promotion.
Read the detailed description
In this work, Stroke is a disease with a high incidence, high mortality and high disability rate, and it is becoming increasingly common in young individuals. More than 50% of these patients have long-term chronic motor dysfunction due to unilateral limb dysfunction, and abnormal limb movement patterns occur due to unilateral limb weakness, abnormal muscle tone and other symptoms, which can manifest as a typical "hemiplegic gait" on walking. Motor dysfunction after stroke, including muscle strength, dystonia and abnormal gait, is the main dysfunction, which can cause cardiopulmonary function decline, thrombosis, muscle atrophy, etc., reducing the ability of daily living and quality of life of patients. Routine rehabilitation training methods for stroke patients with dysfunction include muscle strength training techniques, neurodevelopmental treatment (NDT), motor relearning programs (MRPs), constraint-induced movement therapy (CIMT), neuromuscular electrical stimulation (NMES). But it cannot achieve a good rehabilitation treatment effect. Therefore, we found through lower extremity motor function (LE-FMA), balance function (BBS), activities of daily living (MBI), patients' walking distance (6-MWT test) and the MMT assessment of muscle strength of iliopsoas, quadriceps, hamstrings and tibialis anterior muscles testing that combining blood flow restriction training on the basis of traditional rehabilitation is beneficial for patient muscle rehabilitation.
- Being tested
- Blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictionBehavioural
A common clinical tourniquet (7cm * 50cm in size) is placed in the middle section of the patient's thigh on the affected side, connected to a pressure gauge, observed and gradually pressurized to 160-170mmHg for about 10 minutes, then depressurized for 1 minute, and then re pressurized to 160-170mmHg. Each training session lasts for 20 minutes, once a day, five times a week, for a total of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| routine rehabilitation | No intervention | Bridge exercise: Before conducting specific tests, participants should familiarize themselves with the relevant test actions and procedures. The key points of bridge exercise are: the subject is placed in a supine position, with both hands crossed in the center of the abdomen, the knee joint flexed, both feet flat on the bed surface, and the buttocks lifted off the bed surface with force. The patient is instructed to do bridge exercise as much as possible until the knee joint, hip joint, and neck are on the same line, which is considered qualified for bridge exercise; |
| routine rehabilitation+blood flow restriction training | Experimental | Bridge exercise: Before conducting specific tests, participants should familiarize themselves with the relevant test actions and procedures. The key points of bridge exercise are: the subject is placed in a supine position, with both hands crossed in the center of the abdomen, the knee joint flexed, both feet flat on the bed surface, and the buttocks lifted off the bed surface with force. The patient is instructed to do bridge exercise as much as possible until the knee joint, hip joint, and neck are on the same line, which is considered qualified for bridge exercise; Receives: Behavioral: Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity subscale of Fugl-Meyer motor function assessment (LE-FMA)
The total score of lower limb motor function is 34 points, including 7 major items and 17 minor items. Each minor item has three score levels of 0, 1 and 2. Zero points means that the action cannot be performed, 1 point means that the action can only be partially completed, and 2 points means that the action can be fully completed. The higher the score, the better the lower limb motor function of patients. This scale is widely used in the rehabilitation evaluation of hemiplegic patients and can reflect the lower limb motor function of patients.
Measured: 5 times a week for 8 weeks.
Berg Balance Scale (BBS)
The total score of the scale was 56 points, and there were 14 test items. Each item was rated from 0 to 4. A score of 4 indicated that the patient could perform the needed actions well, and a score of 0 indicated that the patient could not perform the actions at all. The higher the score is, the better the balance ability of the patient.
Measured: 5 times a week for 8 weeks.
The Modified Barthel Index (MBI)
used to evaluate the ability of patients to perform activities of daily living, including the ability to complete daily tasks such as eating, moving, dressing, and walking. The higher the score is, the better the function. The activities related to lower limb function selected in this study included walking, moving, going upstairs, and toileting, with a total of 55 points.
Measured: 5 times a week for 8 weeks.
6-Min Walking Test (6MWT)
The patient is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min, with the primary outcome measure being the 6-min walk distance measured in meters.
Measured: 5 times a week for 8 weeks.
Manual muscle testing (MMT)
Muscle strength refers to the maximum force generated by muscle contraction, ranging from 0-5 grades from low to high. Freehand muscle strength measurement means that the examiner uses the freehand measurement method to make the patient move in different ways to eliminate the influence of compensation or borrowing force and measure the muscle strength of the target muscle group.
Measured: 5 times a week for 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Sorry, the treatment protocol has been changed. Withdrawn: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia and/or Hemiparesis Following 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yunhong Tian
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yunhong Tian, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461013
- Sponsor's protocol ID
- 2023ER378-1
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Training on Lower Limb Motor Function in Stroke Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT06461013
- Acronym / sponsor ID
- 2023ER378-1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sorry, the treatment protocol has been changed. Withdrawn: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yunhong TianOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 14 Jun 2024 (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.
flow restriction training combined with routine rehabilitation training can promote the recovery of lower limb muscle strength on the hemiplegic side of stroke patients, improve the lower limb motor function of patients, and further improve their daily life and walking ability. It provides a new treatment method for stroke patients with hemiplegia that leads to lower limb function loss and activity disorder, and the therapy also has the advantages of simple operation, high safety, good patient compliance and low cost, which is worthy of further clinical research and promotion.
Detailed description
In this work, Stroke is a disease with a high incidence, high mortality and high disability rate, and it is becoming increasingly common in young individuals. More than 50% of these patients have long-term chronic motor dysfunction due to unilateral limb dysfunction, and abnormal limb movement patterns occur due to unilateral limb weakness, abnormal muscle tone and other symptoms, which can manifest as a typical "hemiplegic gait" on walking. Motor dysfunction after stroke, including muscle strength, dystonia and abnormal gait, is the main dysfunction, which can cause cardiopulmonary function decline, thrombosis, muscle atrophy, etc., reducing the ability of daily living and quality of life of patients. Routine rehabilitation training methods for stroke patients with dysfunction include muscle strength training techniques, neurodevelopmental treatment (NDT), motor relearning programs (MRPs), constraint-induced movement therapy (CIMT), neuromuscular electrical stimulation (NMES). But it cannot achieve a good rehabilitation treatment effect. Therefore, we found through lower extremity motor function (LE-FMA), balance function (BBS), activities of daily living (MBI), patients' walking distance (6-MWT test) and the MMT assessment of muscle strength of iliopsoas, quadriceps, hamstrings and tibialis anterior muscles testing that combining blood flow restriction training on the basis of traditional rehabilitation is beneficial for patient muscle rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine rehabilitation | No intervention | –Bridge exercise: Before conducting specific tests, participants should familiarize themselves with the relevant test actions and procedures. The key points of bridge exercise are: the subject is placed in a supine position, with both hands crossed in the center of the abdomen, the knee joint flexed, both feet flat on the bed surface, and the buttocks lifted off the bed surface with force. The patient is instructed to do bridge exercise as much as possible until the knee joint, hip joint, and neck are on the same line, which is considered qualified for bridge exercise; |
| routine rehabilitation+blood flow restriction training | Experimental | Behavioral: Blood flow restrictionBridge exercise: Before conducting specific tests, participants should familiarize themselves with the relevant test actions and procedures. The key points of bridge exercise are: the subject is placed in a supine position, with both hands crossed in the center of the abdomen, the knee joint flexed, both feet flat on the bed surface, and the buttocks lifted off the bed surface with force. The patient is instructed to do bridge exercise as much as possible until the knee joint, hip joint, and neck are on the same line, which is considered qualified for bridge exercise; |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnosis of stroke meets the diagnostic criteria revised by the Fourth National
- Conference on Cerebrovascular Diseases
- Confirmed by cranial CT and/or MRI
- First onset, hemiplegia of one limb, clear consciousness, stable vital signs, no serious complications such as heart, lung, kidney, etc., no serious cognitive or audio-visual impairment
Key exclusion criteria (7 listed)
- Uncontrolled hypertension
- Coronary artery disease
- Uncontrolled autonomic reflex abnormalities
- Severe spasms
- History of fractures or fractures
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 |
|---|---|---|
| Blood flow restrictionA common clinical tourniquet (7cm * 50cm in size) is placed in the middle section of the patient's thigh on the affected side, connected to a pressure gauge, observed and gradually pressurized to 160-170mmHg for about 10 minutes, then depressurized for 1 minute, and then re pressurized to 160-170mmHg. Each training session lasts for 20 minutes, once a day, five times a week, for a total of 8 weeks. | Behavioural | routine rehabilitation+blood flow restriction training |
Primary outcome
Lower extremity subscale of Fugl-Meyer motor function assessment (LE-FMA)
Time frame: 5 times a week for 8 weeks.
The total score of lower limb motor function is 34 points, including 7 major items and 17 minor items. Each minor item has three score levels of 0, 1 and 2. Zero points means that the action cannot be performed, 1 point means that the action can only be partially completed, and 2 points means that the action can be fully completed. The higher the score, the better the lower limb motor function of patients. This scale is widely used in the rehabilitation evaluation of hemiplegic patients and can reflect the lower limb motor function of patients.
Berg Balance Scale (BBS)
Time frame: 5 times a week for 8 weeks.
The total score of the scale was 56 points, and there were 14 test items. Each item was rated from 0 to 4. A score of 4 indicated that the patient could perform the needed actions well, and a score of 0 indicated that the patient could not perform the actions at all. The higher the score is, the better the balance ability of the patient.
The Modified Barthel Index (MBI)
Time frame: 5 times a week for 8 weeks.
used to evaluate the ability of patients to perform activities of daily living, including the ability to complete daily tasks such as eating, moving, dressing, and walking. The higher the score is, the better the function. The activities related to lower limb function selected in this study included walking, moving, going upstairs, and toileting, with a total of 55 points.
6-Min Walking Test (6MWT)
Time frame: 5 times a week for 8 weeks.
The patient is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min, with the primary outcome measure being the 6-min walk distance measured in meters.
Manual muscle testing (MMT)
Time frame: 5 times a week for 8 weeks.
Muscle strength refers to the maximum force generated by muscle contraction, ranging from 0-5 grades from low to high. Freehand muscle strength measurement means that the examiner uses the freehand measurement method to make the patient move in different ways to eliminate the influence of compensation or borrowing force and measure the muscle strength of the target muscle group.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Yunhong Tian at 1 site in China.
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 7 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: withdrawn, as of the sponsor's last update on 17 Jun 2024. 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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?
Lower extremity subscale of Fugl-Meyer motor function assessment (LE-FMA) (time frame: 5 times a week for 8 weeks.). 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?
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 17 Jun 2024.