NCT01662960

Brief Summary

The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

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

First Submitted

Initial submission to the registry

August 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

September 7, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 13, 2019

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

4.5 years

First QC Date

August 8, 2012

Results QC Date

February 12, 2019

Last Update Submit

June 19, 2020

Conditions

HemiparesisStroke

Keywords

strokehemiparesisarm movementsensory functioning

Outcome Measures

Primary Outcomes (4)

  • Upper Extremity Fugl-Meyer

    This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.

    Immediately after 1 month of treatment

  • Action Research Arm Test

    The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.

    1 month

  • Rivermead Assessment of Somatosensory Performance

    This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.

    1 month

  • Virtual-reality Assessment of Navigation

    This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.

    1 month

Secondary Outcomes (2)

  • Stroke Impact Scale

    1 month

  • Wolf Motor Function Test

    1 months

Study Arms (2)

Mirror therapy

EXPERIMENTAL

4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.

Behavioral: Mirror therapy

Divider therapy

ACTIVE COMPARATOR

4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.

Behavioral: Divider therapy

Interventions

Mirror therapyBEHAVIORAL

A home-based therapy involving mirrored visual feedback

Mirror therapy
Divider therapyBEHAVIORAL

A home-based therapy involving removed visual feedback.

Divider therapy

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • months or more post-stroke
  • upper extremity Fugl-Meyer score between 10 and 50
  • no longer participating in upper-extremity physical or occupational therapy
  • sufficient comprehension ability to understand instructions

You may not qualify if:

  • previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Einstein Medical Center Elkins Park

Elkins Park, Pennsylvania, 19027, United States

Location

MeSH Terms

Conditions

ParesisStroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Results Point of Contact

Title
Dr. Steven Jax
Organization
Albert Einstein Healthcare Network
stevenandrewjax@gmail.com
215-870-0196

Study Officials

  • Steven Jax, Ph. D.

    Albert Einstein Healthcare Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute Scientist

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 13, 2012

Study Start

September 7, 2012

Primary Completion

February 27, 2017

Study Completion

February 27, 2017

Last Updated

June 30, 2020

Results First Posted

May 13, 2019

Record last verified: 2020-06

Locations

US(1)