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

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Other: Conventional Physical Therapy; Other: CIMT

• Registration Number: NCT03604081
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-27
• Status Verified: 2020-08
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-14
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Conventional Physical Therapy	Conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.
Intervention Group	CIMT	One hour of intense massed practice of lower extremity either in the form of shaping or task practice

Primary Outcome Measures

Name	Time	Method
Stride length as measured by GAITRite.	2 Weeks	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.
velocity as measured by GAITRite	2 Weeks	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.
Cycle time as measured by GAITRite.	2 Weeks	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.
step length as measured by GAITRite.	2 Weeks	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States