The Effect of Blood Flow Restriction Training on Lower Limb Motor Function in Stroke Patients With Hemiplegia

June 14, 2024 updated by: Yunhong Tian
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Zhangqin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Uncontrolled hypertension
  • Coronary artery disease
  • Uncontrolled autonomic reflex abnormalities
  • Severe spasms
  • History of fractures or fractures
  • Deep vein thrombosis
  • Cognitive impairment, inability to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: routine rehabilitation
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;
Experimental: routine rehabilitation+blood flow restriction training
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;
Behavioral: Blood flow restriction
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 times a week for 8 weeks.
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.
5 times a week for 8 weeks.
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.
5 times a week for 8 weeks.
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.
5 times a week for 8 weeks.
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.
5 times a week for 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yunhong Tian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023ER378-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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