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

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• Status: Withdrawn
• Conditions: Hemiplegia and/or Hemiparesis Following Stroke
• Intervention / Treatment: Behavioral: Blood flow restriction

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	5 times a week for 8 weeks.

Collaborators and Investigators

• Sponsor: Yunhong Tian

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia; Paresis
• Other Study ID 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