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

NCT ID: NCT06461013

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-01-01

Brief 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. 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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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;

Group Type: NO_INTERVENTION

No interventions assigned to this group

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;

Group Type: EXPERIMENTAL

Blood flow restriction

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yunhong Tian

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yunhong Tian

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhangqin

Nanchong, Sichuan, China

Countries

China

Other Identifiers

2023ER378-1

Identifier Type: -

Identifier Source: org_study_id