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.

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

Sponsors

Lead sponsor: NYU Langone Health

Source 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.

Overall Status Suspended
Start Date June 11, 2018
Completion Date August 14, 2020
Primary Completion Date August 14, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cycle time as measured by GAITRite. 2 Weeks
step length as measured by GAITRite. 2 Weeks
Stride length as measured by GAITRite. 2 Weeks
velocity as measured by GAITRite 2 Weeks
Enrollment 24
Condition
Intervention

Intervention type: Other

Intervention name: CIMT

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

Arm group label: Intervention Group

Intervention type: Other

Intervention name: Conventional Physical Therapy

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

Arm group label: Control Group

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.

Gender: All

Minimum age: 55 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nada Abou-Fayssal, MD Principal Investigator NYU Langone Health
Location
facility
New York University School of Medicine
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intervention Group

Arm group type: Experimental

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

Arm group label: Control Group

Arm group type: Placebo Comparator

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

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov