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临床试验/NCT06859905
NCT06859905已完成不适用

The Effectiveness of Blood Flow Restriction Training on Upper Limb Motor Function, Strength, and Activity of Daily Living in Hemiparesis Post-stroke Patients

University of Hail1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Muscle power

研究概览

简要总结

Background; Blood flow restriction training (BFRT) is a physical intervention that promotes many beneficial muscular activities and functions when low load/intensity is used in healthy and clinical populations.

Objectives: To determine the effect of BFRT on upper extremity motor function, strength, and Activity of daily living in chronic/acute stroke patients.

详细描述

A cerebrovascular accident (CVA) is often known as a stroke and can be described as a localized neurological deficiency caused by various cardiovascular abnormalities that disrupt brain function. Stroke is the primary cause of death worldwide, it also leads to a substantial number of disability among the population.

There is no doubt that stroke is one of the most common causes of adult-onset disabilities. 70-85% of the first strokes are associated with hemiplegia which is usually followed by hemiparesis. Only 60% of patients suffering from hemiparesis need physical rehabilitation and have attained functional independence in basic activities of daily living (ADLs) such as using the restroom and short-distance walking. Patients with sensorimotor and visual-field loss are much more dependent on care than those with pure motor impairments.

Stroke patients require post-stroke rehabilitation and physical therapy procedures to improve their recovery and quality of life. A multidisciplinary approach that addresses each patient's unique physical, occupational, and speech deficits can assist optimize their functional abilities and encourage independence.

Hemiplegic stroke rehabilitation involves structured, interdisciplinary, supportive services that start 48 hours after the stroke starts for stable patients. Although patients and families generally benefit from inpatient and outpatient rehabilitation, each treatment modality's efficacy falls short of standards set by evidence-based therapy (reference). Rehabilitation has always been around teaching patients how to compensate with their unaffected arm or limb. The major goals of physical, occupational, and speech therapists are to modify the surroundings and develop new skills in order to keep patients at home with the least amount of care assistance. The removal of architectural impediments to movement, problem-solving techniques, supporting social and psychological services, braces and other orthotics, and equipment like wheelchairs and walkers all continue to be crucial in assisting patients in doing daily life tasks (Dobkin, 2004).

The goal of physical therapy rehabilitation modalities post-stroke is to enhance activities of daily living, enhance range of motion, reduce pain, and improving muscle tone. Previous studies on BFRT have focused on healthy populations, limited number of observational trials have been performed on BFRT in patients with neurological problems, such as Parkinson's disease, multiple sclerosis, spinal cord injury, and stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

the participants will be allocated using the closed-envelop method with each envelop containing a card with a coded number. Particiants will be treated using these code numbers throughout the study. only the outcome assessor will not be allowed to have the interpritation of the coded numbers till the end of the study

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 ≥ years of age.
  • The diagnosis of stroke
  • Confirmed by cranial CT and/or MRI
  • Hemipaises (weakness of one side of the body ), clear consciousness, stable vital signs

排除标准

  • Uncontrolled hypertension
  • Coronary artery disease
  • Deep vein thrombosis
  • Severe osteoarthritis
  • Cognitive impairment, inability to cooperate
  • Any severe musculoskeletal problem that prevented the participants from doing resistance training
  • unstable complications related to heart, lung, and kidney diseases.
  • Serious cognitive or audio-visual impairment
  • Mini-Mental Scale Examination score, <24)

研究组 & 干预措施

study group

Experimental

this group will receive blood flow restriction training (BFRT) plus regular exercises for the upper extremity for 8 weeks

干预措施: blood flow restriction training (Other)

study group

Experimental

this group will receive blood flow restriction training (BFRT) plus regular exercises for the upper extremity for 8 weeks

干预措施: regular exercises (Other)

control group

Active Comparator

this group will receive regular exercises for 8 weeks

干预措施: regular exercises (Other)

结局指标

主要结局

Muscle power

时间窗: at base line and after 8 weeks of tretment

muscle power will be assessed using by Manual muscle test for shoulder and elbow flexor and extensor

2- Hand grip strength

时间窗: at base line and after 8 weeks of tretment

handgrip strength will be measured using (hand dynamometer ) Based on previous studies, the JAMAR® Hydraulic Hand Dynamometer has been widely used, and has been validated and reliable. 1. The subject should sit with the back, pelvis, and knees as close to 90 degrees as possible. 2. The shoulder is adducted and neutrally rotated, elbow at 90 degrees flexion, forearm neutral, wrist held between 0-15 degrees of ulnar deviation. 3. A dynamometer is placed vertically on the forearm without support from the examiner or armrest. 4. Three trials are taken to determine the maximum grip.

The Stroke Upper-Limb Capacity Scale

时间窗: at base line and after 8 weeks of tretment

The Stroke Upper-Limb Capacity Scale (SULCS) is a validated tool for upper extremity (UE) functional tasks, SULCS measures upper limb capacity, including basic arm capacities. There are ten items in the SULCS that represent meaningful tasks that relate to daily activities at home. The selection of these tasks was based on extensive interviews with rehabilitation physicians, occupational therapists, and physical therapists

Activity of daily living by Barthel Index

时间窗: at base line and after 8 weeks of tretment

Activity of daily living by Barthel Index Functional independence was assessed using the Barthel Index, validated for cerebrovascular diseases and elderly , The index analyzes 10 aspects: bowels, bladder, grooming, toilet use, feeding, transfer, mobility, dressing, stairs, and bathing. The total score ranges from 0 to 100 points. The higher the score, the greater the functional independence

次要结局

  • Modified Disability Arm Shoulder Hand(at base line and after 8 weeks of tretment)
  • Patient satisfaction (PSQ 18)(at base line and after 8 weeks of tretment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdelmoniem Ibrahim

Associate Professor

University of Hail

研究点 (1)

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