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临床试验/NCT04173481
NCT04173481已完成不适用

Effects of ROOD's Sensory Motor Training Along With Constraint Induced Movement Therapy in Sub-acute Stroke

Riphah International University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Wolf Motor Function Test

研究概览

简要总结

The aim of this randomized controlled trial is to determine the effects of ROOD's sensory motor training along with Constraint Induced Movement Therapy (CIMT) in sub-acute stroke. Two randomized groups of patients with stroke were treated with conservative physical therapy and the experimental group was given ROOD's SMT and CIMT in conjunction with conservative rehabilitation. Both, male and female patients meeting the inclusion criteria were included. Patients having other neurological disease, chronic disease, not compatible being participates in CIMT or with any surgical intervention were excluded.

详细描述

The study is aimed at determining the effects of ROOD's sensory motor training along with constraint induced movement therapy in sub-acute stroke and is being conducted in National Institute of Rehabilitation Medicine Islamabad and Pakistan Railway General Hospital, Rawalpindi (Feb 2019-July 2019). Sample size of the study is 36 patients, 36 were included in the study on the basis of inclusion criteria, 18 for each group. Patients were allocated randomly and equally in each group. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ROOD's sensory motor training and CIMT training. Patients were examined at 1st visit before administration of any treatment and at 6th week which was also the last one (after completing 6 weeks sessions at alternate days). Baseline evaluation for demographics and assessment was taken. Fugyl-meyer assessment scale(FMA) and Wolf motor function test(WMFT) as measuring tools were used for first and 6th week assessment. 29 patients completed the study while 4 patient from control group and 3 patients from experiment group were lost to follow up and were considered drop outs.

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
None

入排标准

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

入选标准

  • Right & Left hemiplegia
  • Ischemic & Hemorrhagic stroke
  • Compatible with being participate in CIMT i.e. 10ºwrist extension,10ºany two fingers extension,10ºthumb abduction
  • Duration of stroke between 6 weeks to 6 months

排除标准

  • Not compatible with being participate in CIMT
  • Any other neurological disease e.g. Parkinson's disease, brain tumors
  • Chronic disease e.g. Ischemic Heart Disease, tumors, Diabetes Mellitus
  • Behaviors issues, not willing to participate
  • Surgical intervention that hinders treatment and assessment
  • Not well oriented to follow designed motor task

结局指标

主要结局

Wolf Motor Function Test

时间窗: 6 weeks

Changes from the baseline, Wolf motor function test is a test of motor ability that is use to evaluate the speed and coordination. Total of 17 tasks performed by the patient. Scoring: The items are rated on a 6-point scale as 0-6.

Fugyl-meyer motor assessment scale

时间窗: 6 weeks

Changes from the baseline, Fugyl-meyer assessment scale is use to assess voluntary movements, reflex activity, grasping and coordination of affected limb in stroke. FMA upper extremity portion contain 33 tasks with a scale 0 to 2 with maximum scoring of 66.

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 (2)

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