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

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03604081

Collaborator

(none)

Enrollment

Location

Arms

26.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: CIMT Other: Conventional Physical Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Jun 11, 2018

Actual Primary Completion Date :

Aug 14, 2020

Actual Study Completion Date :

Aug 14, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention Group

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

Other: CIMT

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

Placebo Comparator: Control Group

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

Other: Conventional Physical Therapy

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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Nada Abou-Fayssal, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03604081

Other Study ID Numbers:

17-00773

First Posted:

Jul 27, 2018

Last Update Posted:

Sep 2, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

Constraint Induced Movement Therapy

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 2, 2020