- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01586221
Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke (MT/PT)
July 19, 2017 updated by: NYU Langone Health
A Collaborative Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Music & Physical Therapy
Subjects will received Music and Physical Therapy in a group setting.
|
Participants will receive combined Music Therapy and Physical Therapy for 6 Weeks.
Two times per week for 1 hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Base Line Measurement of Hand Function
Time Frame: Beginning of study
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand Function after Therapy
Time Frame: After completion of therapy
|
Participants will be assessed after 6 weeks of Therapy for:
|
After completion of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
April 9, 2012
First Submitted That Met QC Criteria
April 24, 2012
First Posted (Estimate)
April 26, 2012
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-02284
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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