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

Hemiplegia and/or Hemiparesis Following Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06461013
• Other study ID #: 2023ER378-1
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2024
• Source: Nanchong Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegia and/or Hemiparesis Following Stroke
• Paresis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Zhangqin	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Yunhong Tian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.