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

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Other: CIMT; Other: Conventional Physical Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): August 14, 2020
• Study Completion (Actual): August 14, 2020

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Constraint Induced Movement Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 17-00773

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No