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Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke (MT/PT)

Primary Purpose

Stroke With Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music & Physical Therapy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke With Hemiparesis focused on measuring Rehabilitation, Fingers, Grasp, Strength, Brain Function, Physiopathology, Functional Laterality, Psychomotor Performance, Biomechanis, Touch, Music Therapy, Weight-Bearing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Neurological or psychiatric disease such as clinical depression
  2. Hearing deficits
  3. History of surgery or other significant injury that could preclude task performance
  4. 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
  5. Any factors that may put the subject at significant risk or confound study results

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Music & Physical Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hand Function after Therapy
Participants will be assessed after 6 weeks of Therapy for: change in hand motor impairment during a functional grasp and lift tasks Hand Function

Full Information

First Posted
April 9, 2012
Last Updated
July 19, 2017
Sponsor
NYU Langone Health
Collaborators
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT01586221
Brief Title
Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke
Acronym
MT/PT
Official Title
A Collaborative Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
New York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The purpose of the study is to investigate the feasibility and efficacy of an "enriched," combined music therapy/physical therapy (MT/PT) rehabilitation intervention that addresses physical, psychological, and social well-being simultaneously in a group setting to enhance post-stroke recovery. The intervention will be implemented through collaboration between the Nordoff-Robbins Center for Music Therapy at NYU Steinhardt and the Motor Recovery Laboratory at the Rusk Institute of Rehabilitation Medicine, NYU Medical Center.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke With Hemiparesis
Keywords
Rehabilitation, Fingers, Grasp, Strength, Brain Function, Physiopathology, Functional Laterality, Psychomotor Performance, Biomechanis, Touch, Music Therapy, Weight-Bearing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music & Physical Therapy
Arm Type
Other
Arm Description
Subjects will received Music and Physical Therapy in a group setting.
Intervention Type
Other
Intervention Name(s)
Music & Physical Therapy
Intervention Description
Participants will receive combined Music Therapy and Physical Therapy for 6 Weeks. Two times per week for 1 hour.
Primary Outcome Measure Information:
Title
Base Line Measurement of Hand Function
Description
Participants will be assessed prior to starting therapy: - Measurement of current hand motor impairment during a functional grasp and lift tasks
Time Frame
Beginning of study
Secondary Outcome Measure Information:
Title
Hand Function after Therapy
Description
Participants will be assessed after 6 weeks of Therapy for: change in hand motor impairment during a functional grasp and lift tasks Hand Function
Time Frame
After completion of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti Raghavan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27774059
Citation
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.
Results Reference
derived

Learn more about this trial

Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke

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