NCT01586221

Brief Summary

The purpose of this study is to see if group Music Therapy and Physical Therapy will help in the recovery from stroke. It is hoped that music and physical therapy in a group setting will help physical, mental, and social well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

4.3 years

First QC Date

April 9, 2012

Last Update Submit

July 19, 2017

Conditions

Keywords

RehabilitationFingersGraspStrengthBrain FunctionPhysiopathologyFunctional LateralityPsychomotor PerformanceBiomechanisTouchMusic TherapyWeight-Bearing

Outcome Measures

Primary Outcomes (1)

  • Base Line Measurement of Hand Function

    Participants will be assessed prior to starting therapy: \- Measurement of current hand motor impairment during a functional grasp and lift tasks

    Beginning of study

Secondary Outcomes (1)

  • Hand Function after Therapy

    After completion of therapy

Study Arms (1)

Music & Physical Therapy

OTHER

Subjects will received Music and Physical Therapy in a group setting.

Other: Music & Physical Therapy

Interventions

Participants will receive combined Music Therapy and Physical Therapy for 6 Weeks. Two times per week for 1 hour.

Music & Physical Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read and write in English
  • Unilateral stroke at least 6 months prior
  • Independent community ambulation with or without assistive devices
  • Presence of at least 5 degrees of active motion in proximal and distal upper extremity joints, suggesting presence of a neural substrate for recovery

You may not qualify if:

  • Neurological or psychiatric disease such as clinical depression
  • Hearing deficits
  • History of surgery or other significant injury that could preclude task performance
  • Complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease
  • Any factors that may put the subject at significant risk or confound study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Raghavan P, Geller D, Guerrero N, Aluru V, Eimicke JP, Teresi JA, Ogedegbe G, Palumbo A, Turry A. Music Upper Limb Therapy-Integrated: An Enriched Collaborative Approach for Stroke Rehabilitation. Front Hum Neurosci. 2016 Oct 7;10:498. doi: 10.3389/fnhum.2016.00498. eCollection 2016.

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Preeti Raghavan, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2012

First Posted

April 26, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations