NCT02524015

Brief Summary

The purpose of this study is to see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome."

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

August 7, 2015

Last Update Submit

November 17, 2017

Conditions

Keywords

strokepusher syndromecontraversive pushinglateropulsionrehabilitationphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Recovery from pusher syndrome as measured by changes in the Burke Lateropulsion Scale score over time.

    The Burke Lateropulsion Scale (BLS) is used in the literature to measure the presence of pusher syndrome. We will measure BLS upon admission and at weekly intervals to monitor whether patients in the experimental group demonstrate faster recovery than the control group, as demonstrated by change in BLS score over change in time (days).

    Initial, and then weekly until discharge from inpatient rehabilitation unit. Average inpatient stay is expected to be no greater than 4 weeks.

Study Arms (2)

Control

OTHER

Standard Physical Therapy

Other: Standard physical therapy

Intervention

EXPERIMENTAL

Novel Physical Therapy

Other: Novel physical therapy

Interventions

Eligibility Criteria

Age21 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recent (within 2 months) unilateral stroke
  • Burke Lateropulsion Scale ≥ 2
  • Age 21 to 89 years
  • Ability to provide informed consent
  • English-speaking

You may not qualify if:

  • Prior stroke within the past 6 months
  • Cerebellar stroke
  • Stroke-related brain imaging (MRI or CT) unavailable
  • Global or receptive aphasia
  • Prior documented neurologic disorder (e.g., multiple sclerosis, Parkinson's)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Residency Program Director, PM&R

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 14, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11