Back to resultsEffectiveness 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
Primary Purpose
Stroke
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CIMT
Conventional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Constraint Induced Movement Therapy
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
One hour of intense massed practice of lower extremity either in the form of shaping or task practice
Conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03604081
Brief 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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI has encountered recruitment challenges.
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
August 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Constraint Induced Movement Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
One hour of intense massed practice of lower extremity either in the form of shaping or task practice
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.
Intervention Type
Other
Intervention Name(s)
CIMT
Intervention Description
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
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
1 hour as per current standard of care that follows stroke clinical practice guideline.
Primary Outcome Measure Information:
Title
Cycle time as measured by GAITRite.
Description
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.
Time Frame
2 Weeks
Title
step length as measured by GAITRite.
Description
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.
Time Frame
2 Weeks
Title
Stride length as measured by GAITRite.
Description
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.
Time Frame
2 Weeks
Title
velocity as measured by GAITRite
Description
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.
Time Frame
2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nada Abou-Fayssal, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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