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

NCT03604081 | Withdrawn

• 1 other identifier: 17-00773
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Constraint Induced Movement Therapy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: CIMT

Control Group

PLACEBO COMPARATOR

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

Other: Conventional Physical Therapy

Interventions

CIMT OTHER

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

Intervention Group

Conventional Physical Therapy OTHER

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

Control Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nada Abou-Fayssal, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: June 11, 2018
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)