Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice

Study Overview
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Brief Summary
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This is a prospective randomized control trial of patients with unilateral impairment of the lower extremity after stroke. Patients will be randomized to intervention group and control group. Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice. Control group will receive conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.

Official Title
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Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice, 7 Times Per Week for 2 Weeks.

Conditions
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Stroke

Intervention / Treatment
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* Other: CIMT
* Other: Conventional Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55 or older new ischemic stroke as revealed by CT scan or MRI of a brain or as per updated definition by American heart and American stroke association (Sacco et al., 2013) Manual muscle testing with grad of > 1+ in hip and knee joint musculature able to walk atleast 10 feet indoors with or without assistance and assistive device. Motivated to participate and some initiation of flexion and extension movement in hip, knee and ankle joints. Ability to follow visual/verbal instructions as assessed by a minimum score of 24/30 points on the minimental state examination Fairly intact sensation Exclusion Criteria: Serious cardiac or pulmonary condition or other medical condition that make it difficult or risky to participate in intensive training Severe joint pain or degenerative disease to the musculoskeletal system of the lower extremity other neurological disease 4) problems with following instructions.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>One hour of intense massed practice of lower extremity either in the form of shaping or task practice | Other: CIMT<br>* Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice.<br>|
| Placebo Comparator: Control Group<br>Conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline. | Other: Conventional Physical Therapy<br>* 1 hour as per current standard of care that follows stroke clinical practice guideline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle time as measured by GAITRite. | GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity. | 2 Weeks | 
| step length as measured by GAITRite. | GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity. | 2 Weeks | 
| Stride length as measured by GAITRite. | GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity. | 2 Weeks | 
| velocity as measured by GAITRite | GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity. | 2 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constraint Induced Movement Therapy