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临床试验/CTRI/2016/09/007248
CTRI/2016/09/007248进行中(未招募)3 期

Role of less affected upper extremity in post stroke rehabilitation

Pt Deendayal Upadhyaya Institute for the Physically Handicapped1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年9月17日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Fugl-Meyer assessment, Purdue peg board test, Minnesota rate of manipulation test (MRMT)

研究概览

简要总结

Background: The damage of some fibers of the corticospinal tract may lead tomild to moderate impairment on sound side also. The sound side (the"unaffected"side) is often considered a reference point.It is thereforeassumed that this side has no deficit. Nevertheless,previousresearch suggests or tends to show diminished strength intheunaffected upper limb whencomparedwithhealthy subjects. However, the rehabilitation protocols emphasized only on theaffected side. In spite of this majority of the stroke population do not achievecomplete or satisfactory motor recovery of the affected side.  Animal studies have shown that the retrainingof the less affected side also, leads to better cortical reorganization whichin turn add up  to improved motorrecovery of the affected upper limb.

Objectives

·       Tostudy the level of impairment in less affected upper extremity of strokepatients

·       Tocompare the  preference between dominantand non-dominant less affected hand

·       Todevelop Occupational therapy intervention protocol focused on intralimb(bilateral upper limb) coordination and exclusive strengthening & dexteritytraining of the less affected side

·      Tostudy the effect of the protocol in comparison to the conventional program

Methodology

StudyDesign: Part- I Comparison of less affected upper limb of post stroke patients withmatched able body individuals (Non-experimental: observational). Part-IIComparison of the new treatment protocol with the conventional (experimental;randomized controlled trial)Place of study: Department of Occupational Therapy, PDUIPH

Inclusioncriteria**:** Age: 40 to 60 year, bothmale & female**,** Hemiparesis(right / left), unilateral stroke(Ischemic / hemmorhagic), 4 to 12 months after stroke

Exclusioncriteria**:** Receptive communicationdisorder**,** Cerebellar or thalamicinfarct**,** Uncontrolledsystemic  or cardiovascular disease**,multiple stroke,** Ataxia**,** Severecognitive / perceptual deficit

 Samplesize:  30 post strokepatients (Pilot study) and 30 matched able body individuals (Allthe participants will be enrolled after obtaining signed informed consent form)

SamplingMethod: Sample of convenience, Random assignment

Outcomemeasures: Purdue peg board test, Minnesota rate ofmanipulation test (MRMT) (Both themeasures are already available in the Department of Occupational therapy,PDUIPH

Deliverableoutcomes

·       Thepresent study will lead to development of rehabilitation protocol whichencompasses less affected side also.

·      Assessmentand training of less affected upper extremity will enhance better motor andfunctional outcome in post stroke survivors.

研究设计

研究类型
Interventional

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 40 to 60 year, both male & female, Hemiparesis (right / left), unilateral stroke (Ischemic / hemmorhagic), 4 to 12 months after stroke.

排除标准

  • Receptive communication disorder, Cerebellar or thalamic infarct, Uncontrolled systemic or cardiovascular disease, multiple stroke, Ataxia, Severe cognitive / perceptual deficit.

结局指标

主要结局

Fugl-Meyer assessment, Purdue peg board test, Minnesota rate of manipulation test (MRMT)

时间窗: pre, at 6th week post intervention

次要结局

  • brunnstrom recovery stage, MMT grades(pre, at 6th week post intervention)

研究者

发起方
Pt Deendayal Upadhyaya Institute for the Physically Handicapped
申办方类型
Other [Government Institution]

研究点 (1)

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