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临床试验/NCT05033873
NCT05033873招募中不适用

Comparison of Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
SHORT FORM 12 (SF-12): (QUALITY OF LIFE)

研究概览

简要总结

Stroke occurred when blood supply to brain or a part of brain is disturbed due to clot (ischaemic stroke) or due rupture of small vessels (hemorrhagic stroke) in brain and causes bleeding in brain cells. The prevalence of stroke was 1.2 % (1200/100,000) in Pakistan, 3.1% in China and it is 44.29 to 559/100,000 in different parts of the world. Leading cause of stroke is hypertension. The aim of study will be to compare universal exercise unit therapy with sling exercise therapy on lower limb kinematics, disability, balance and quality of life in chronic stroke patients.

详细描述

This will be randomized controlled trial. Study will be conducted at Khawaja Arshed Hospital Sargodha. Duration of intervention will be 08 weeks, 5 sessions in a week, total 40 sessions. Duration of single session will be one hour. A convenient sample of n patients fulfilling the inclusion and exclusion criteria will be selected from in-patient settings of various hospitals from the city Sargodha and will be allocated randomly into three groups equally after taking informed consent. Group A will obtain Universal Exercise Unit Therapy. Group B will obtain Sling Exercise Therapy and Group C will be control and will receive routine physical therapy. Outcome will be measured at baseline, 04 weeks and 08 weeks. Outcome measurement tools will be Berg balance scale, Barthel index, Short form 12 (SF-12), Trunk impairment scale, functional reach test and smart phone motion analysis for lower limb kinematics. Scores will be measure in mean and SD. Results of intervention will be comparing by using one way ANOVA by using IBM SPSS version 21.0

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
Double (Participant, Outcomes Assessor)

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
否

入选标准

  • •Patient with chronic (course of disease at least six month)
  • •Recently discharge from in-patients setting with in 06 month of onset
  • •Hemiplegia (either right or left)
  • •Both gender
  • •Age between 30 to 70
  • •Medically stable
  • •No balance disorders before this stroke.
  • •History of mental
  • •illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE > 25)

排除标准

  • •Stroke Patient with complication like shoulder hand syndrome, adhesive capsulitis or shoulder partial dislocation
  • •Stroke patients with behavioral issue, significant cognitive deficit
  • •Patients with arthritis and fracture
  • •Chronic stroke with deformities
  • •Serious viscera dysfunction, such as cardiovascular system,
  • •Lung, liver and kidney
  • •History of mental
  • •Illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE > 25)
  • •Audio-visual understanding
  • •obstacle, unable to cooperate with instructions;
  • •Infection and ulcer skin

研究组 & 干预措施

Group C: Control Group

Other

Control group will be given routine physical therapy

干预措施: Routine Physical Therapy / Control Group (Other)

Group A: Universal Exercise Unit Therapy (UEU)

Experimental

This experimental group will be given universal exercise unit therapy.

干预措施: Universal Exercise Unit Therapy (UEU) (Other)

Group B: Sling Exercise Therapy (SET)

Experimental

This experimental group will be given sling exercise therapy

干预措施: Sling Exercise Therapt (SET) (Other)

结局指标

主要结局

SHORT FORM 12 (SF-12): (QUALITY OF LIFE)

时间窗: 2 months

This survey contains 12 items divided into eight domains: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role-emotional (RE), and mental health (MH). According to the calculation formula, raw scores were converted into final scores. As scores increased, health status and quality of life increased for the subject.

SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING

时间窗: 2 months

Sagittal plane hip, knee, and ankle angle and rear foot eversion will be assessed by using the Coach's Eye Smart phone application

BARTHEL INDEX: (FUNCTIONAL ABILITY)

时间窗: 2 months

This index is used to measure the activities of daily life, having total 10 items and can be scored from 0 to 100.

THE BERG BALANCE SCALE: (BALANCE FUNCTION)

时间窗: 2 months

This scale will be used to check the balance of the patients during the functional activities. Scale consists of 14 tasks and each task can be scored between 0 and 4. Overall balance score ranges from 0 to 56. 0 score is showing severely damage balance and 56 score is showing excellent balance. A score below 40 indicate the risk of falling in particular function.

FUNCTIONAL REACH TEST

时间窗: 2months

Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the lengths of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

TRUNK IMPAIRMENT SCALE

时间窗: 2 Months

The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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