NCT04989920

Brief Summary

This project is designed to use three-dimensional movement analysis and magnetic resonance (fMRI) neuroimaging techniques to examine the brain activity and motor behavior changes associated with constraint-induced (CI) therapy for patients with sub-acute stroke (3-9 months post-stroke).Participants are evaluated at 5 time points-1-mo (pre \& post), 6-mo (pre \& post), and 12-mo. Each person is randomized to receive CI therapy either between pre- and post-evaluations or after the 6-mo pre-evaluation. We will determine the effects of CI therapy on 1) reaching and grasping actions using behavioral kinematics and 2) the sensorimotor network through fMRI scans with goal-directed aiming and grasping tasks. We will also determine the relationship between lesion size and location using 3-D volumetric MRI scans and behavioral outcomes as a consequence of CI therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2005

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2011

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

July 25, 2021

Last Update Submit

August 2, 2021

Conditions

Stroke, Cardiovascular

Keywords

Constraint-Induced Movement Therapy

Outcome Measures

Primary Outcomes (5)

  • Change in Wolf Motor Function test

    The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.

    Baseline to Immediately post-intervention

  • Change in Wolf Motor Function test

    The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.

    Immediately post-intervention to 6-month follow-up

  • Change in Wolf Motor Function test

    The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.

    Immediately post-intervention to 1 year follow-up

  • Change Motor activity log

    The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.

    Baseline to Immediately post-intervention

  • Change Motor activity log

    The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.

    Immediately post-intervention to 6 months follow-up

Secondary Outcomes (1)

  • Change in Laterality-Index

    Baseline to Immediately post-intervention

Study Arms (2)

CIMT (Constraint-Induced Movement Therapy)

EXPERIMENTAL

Therapy intervention: This arm will deliver the signature Constraint-induced therapy protocol for 60 hrs of training over a two-week period.

Behavioral: Experimental group: CIMT group (Constraint-Induced Movement Therapy)

Delayed (Control) intervention group

NO INTERVENTION

Subjects randomized to the delayed intervention group will receive the "usual and customary" services provided by their personal health care system.

Interventions

Experimental group: CIMT group (Constraint-Induced Movement Therapy)BEHAVIORAL

2 weeks of intensive therapy delivered 5d/week for 6 hrs/day

Also known as: CI group
CIMT (Constraint-Induced Movement Therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 3 - 9 months post first-time stroke of infarct hemorrhagic type at the beginning of participation.
  • \. over the age of 18 years with no upper age limit.
  • \. cleared by a medical physician to participate.
  • \. Independent in basic activities of living.
  • \. minimum motor criteria: at least 10 degrees of active wrist extension, 10 degrees of finger extension in at least two fingers and the thumb (abduction) and the elbow (90 degrees flexion and extension) and shoulder (45 degrees flexion and abduction motion criteria.

You may not qualify if:

  • \. score below 24 on the Folstein Mini-mental status exam (MMSE)
  • \. score greater than an average of 2.5 on the Motor Activity Log (MAL) amount scale
  • \. are concurrently participating in any experimental drug study
  • \. are concurrently participating in any formal physical rehabilitation or clinical trials
  • \. do not meet the minimum motor criteria or who do not meet the minimum balance criteria.
  • \. pre-menopausal woman who is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (3)

  • Tan C, Tretriluxana J, Pitsch E, Runnarong N, Winstein CJ. Anticipatory planning of functional reach-to-grasp: a pilot study. Neurorehabil Neural Repair. 2012 Oct;26(8):957-67. doi: 10.1177/1545968312437938. Epub 2012 Mar 20.

    PMID: 22434022BACKGROUND

  • Dong Y, Dobkin BH, Cen SY, Wu AD, Winstein CJ. Motor cortex activation during treatment may predict therapeutic gains in paretic hand function after stroke. Stroke. 2006 Jun;37(6):1552-5. doi: 10.1161/01.STR.0000221281.69373.4e. Epub 2006 Apr 27.

    PMID: 16645139RESULT

  • Dong Y, Winstein CJ, Albistegui-DuBois R, Dobkin BH. Evolution of FMRI activation in the perilesional primary motor cortex and cerebellum with rehabilitation training-related motor gains after stroke: a pilot study. Neurorehabil Neural Repair. 2007 Sep-Oct;21(5):412-28. doi: 10.1177/1545968306298598. Epub 2007 Mar 16.

    PMID: 17369516RESULT

Related Links

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Carolee J Winstein, PhD

    Company Name (optional)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator was blinded to group membership
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Two group (treated vs waitlisted) crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Biokinesiology and Physical Therapy

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 4, 2021

Study Start

April 28, 2003

Primary Completion

June 30, 2005

Study Completion

July 15, 2011

Last Updated

August 4, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Only secondary and exploratory data analysis analysis code will be shared with other researchers.

Locations

US(1)