Clinical trial NCT06461013: The Effect of Blood Flow Restriction Training on Lower Limb Motor Function in Stroke Patients With Hemiplegia
Official title: The Effect of Blood Flow Restriction Training on Lower Limb Motor Function in Stroke Patients With Hemiplegia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemiplegia and/or Hemiparesis Following Stroke
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Lower extremity subscale of Fugl-Meyer motor function assessment (LE-FMA)
timeFrame: 5 times a week for 8 weeks.
measure: Berg Balance Scale (BBS)
timeFrame: 5 times a week for 8 weeks.
measure: The Modified Barthel Index (MBI)
timeFrame: 5 times a week for 8 weeks.
measure: 6-Min Walking Test (6MWT)
timeFrame: 5 times a week for 8 weeks.
measure: Manual muscle testing (MMT)
timeFrame: 5 times a week for 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Zhangqin
state: Sichuan
Study officials:
References: