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临床试验/NCT07646418
NCT07646418招募中不适用

Combined Effects of Low Intensity Resistance Training With Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor Function in Post-Stroke Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1

研究概览

简要总结

Stroke is a focal neurological deficit of sudden onset, with symptoms lasting more than 24 hours leading to consequences like impacting physical abilities, cognitive functions and emotional well-being, speech and language difficulties. Among various rehabilitation program, Blood flow restriction (BFR) therapy with low intensity resistance training has shown its promising results. Blood flow restriction training, also called Kaatsu, originated in Japan. So this study aims to determine the combined effects of Low Intensity Resistance Training with Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor function in Post-Stroke Patients.

详细描述

It will be a single-blinded randomized controlled trial. Non-probability convenience sampling technique will be used to recruit 64 participants aged 50 to 70 years, one-month post-stroke from hospitals of Sialkot. Sealed opaque method will be used to evenly divide to either Group-BFR therapy or Group-conventional physical therapy. Group-BFR therapy will perform low-intensity resistance exercises at 40% of their 1-RM using 2 kg weights and resistance bands, cuff will be applied at proximal site of upper limb at 150-160 mmHg. Group-conventional physical therapy will perform sensorimotor exercises and strength training with 2-3 kg weights, bands and forward reaching activities. Both groups will perform their respective exercises for 40 minutes, 4 days/week, for 6 weeks. Participants will be evaluated at the baseline and post-intervention exercise program. Outcome measures include the Fugl-Meyer Assessment for upper extremity function, the Functional Reach Test for forward reach, and the Action Research Arm Test for strength. Data will be analyzed using SPSS software 25. After normality testing of the data, the Paired sample t-test will be used for parametric data while Wilcoxon test will be used for non-parametric data in intragroup comparison, while for intergroup comparison, the independent t-test will be for parametric data and Mann-Whitney U test will be used for non-parametric data

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

investigator, an independent assessor, who is blinded to the group allocations, will be responsible for evaluating outcomes, including sensorimotor function, strength, and forward reaching distance of upper limb of post-stroke patients.

入排标准

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

入选标准

  • • 50 to 70 year of age (5)
  • Both males and females (5)
  • Generalized stroke population (both ischemic and hemorrhagic stroke) (9).
  • Post stroke patient after 1 month (5)
  • Barthel index scores ≥ 20 (10)
  • Spasticity level according to Modified Ashworth scale should be 1/+1 grade in the affected upper limb(7)
  • Muscle strength at grade 3 according to MMT of affected upper limb (7)

排除标准

  • • People with a history of mental/cognitive illness (9)
  • History of transient ischemic attack (TIA) or recurrent stroke (8)
  • Diabetes with peripheral neuropathy (5)
  • Having resting blood pressure above 160/100 mmHg even after taking medications
  • Cardiovascular comorbidity (heart failure, unstable angina, aortic stenosis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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