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

NYU Langone Health

Status: Withdrawn

Conditions: Stroke

Treatments: Other: Conventional Physical Therapy; Other: CIMT

Study type: Interventional

Funder types: Other

Identifiers

NCT03604081

17-00773

Details and patient eligibility

About

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.

Sex: All

Ages: 55+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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

Treatment:

Other: CIMT

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Conventional Physical Therapy