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临床试验/NCT06148350
NCT06148350已完成不适用

Regaining Balance and Quality of Life: The Impact of Frenkel's Exercises in Patients With Sub-Acute Ischemic Stroke-A Randomized Controlled Trial

Al- Shifa Physiotherapy Institute /Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Stroke-Specific Quality of Life Scale

研究概览

简要总结

This single-blinded, randomized controlled was aimed to compare the efficacy of Frenkel's and Conventional Balance Exercises in improving balance and quality of life in patients with subacute ischemic stroke. The participants of Group A received 'Frenkel's Exercises'. In contrast, Group B participants received 'Conventional Balance Exercise' interventions three days/week for 30-60 minutes for four weeks. The data was collected pre and post-treatment on the Berg Balance Scale and Stroke Specific-Quality of Life.

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 (Participant)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged between 35 to 75 years.
  • •First-ever ischemic stroke and hemiparesis within 7 to 30 days of onset.
  • •Reduced proprioception of the lower limb with a score of ≤12 on the NSA (kinesthetic and tactile sensation test),
  • •Able to comprehend tasks and follow directions with a score of ≥21 points on the Mini-Mental State Examination (MMSE).
  • •Able to independently perform standing motions for ≥1 minute.

排除标准

  • •Patients with lower limb fractures within 6 months.
  • •Severe pain.
  • •Limited range of motion.
  • •Cerebellar ataxia.
  • •Medically unstable.

研究组 & 干预措施

Group A: Frenkel's Exercise

Experimental

Frenkel's exercises spanned four weeks with distinct positions:

Week 1: Recumbent position, focusing on heel sliding, knee, and hip movements. Week 2: Seated exercises, emphasizing leg elevation and standing from a chair. Week 3: Erect posture activities, including forward, sideways, and backward walking with diverse steps and turns.

Week 4: Comprehensive exercises across all positions, emphasizing varied movements.

Each exercise set included 8-10 repetitions with 1-2 minutes of rest.

干预措施: Stroke Rehabilitation (Other)

Group B: Conventional Balance Exercises

Active Comparator

Structured program with 8-10 reps and 1-2 min rest:

I. Strengthening: Targets hips, knees, and ankles-squats, lunges, leg presses. II. Weight-Shifting: Enhances balance with side-to-side, forward-backward steps.

III. Trunk Stabilization: Improves core control-planks, crunches, twists. IV. Proprioception: Balance board exercises challenge spatial awareness, performed under physiotherapist supervision.

干预措施: Stroke Rehabilitation (Other)

结局指标

主要结局

Stroke-Specific Quality of Life Scale

时间窗: After 4-weeks

The scale measures the quality of life of participants. There are 49 items on the 5-point scale, with the lowest score being 49 and the highest being 245. The higher the quality of life, the lower the score. A Cronbach's alpha of 0.80 was reported as the test's reliability.

Berg Balance Scale

时间窗: After 4-weeks

It has 14 items on a 5-point scale (0-4) and a total score of 56. It has a very high reliability rating, with an ICC of 0.98. Participants who receive scores of 0 to 20 use wheelchairs, those who receive scores of 21 to 40 need aid or assistance, and those who receive scores of 41 or higher have independent gait.

Berg Balance Scale

时间窗: Baseline

The scale assesses dynamic balance skills with 14 items on a 5-point scale (0-4) and a total score of 56. It has a very high-reliability rating, with an ICC of 0.98. Participants who receive scores of 0 to 20 use wheelchairs, those who receive scores of 21 to 40 need aid or assistance, and those who receive scores of 41 or higher have independent gait.

Stroke-Specific Quality of Life Scale

时间窗: Baseline

The scale measures the quality of life of participants. There are 49 items on the 5-point scale, with the lowest score being 49 and the highest being 245. The higher the quality of life, the lower the score. A Cronbach's alpha of 0.80 was reported as the test's reliability.

次要结局

未报告次要终点

研究者

发起方
Al- Shifa Physiotherapy Institute /Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Faisal

Mr. Muhammad Faisal

Al- Shifa Physiotherapy Institute /Clinic

研究点 (1)

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