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

NCT ID: NCT03604081

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2020-08-14

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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

One hour of intense massed practice of lower extremity either in the form of shaping or task practice

Group Type EXPERIMENTAL

CIMT

Intervention Type OTHER

Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice.

Control Group

Conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.

Group Type PLACEBO_COMPARATOR

Conventional Physical Therapy

Intervention Type OTHER

1 hour as per current standard of care that follows stroke clinical practice guideline.

Interventions

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CIMT

Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice.

Intervention Type OTHER

Conventional Physical Therapy

1 hour as per current standard of care that follows stroke clinical practice guideline.

Intervention Type OTHER

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nada Abou-Fayssal, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-00773

Identifier Type: -

Identifier Source: org_study_id

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