Stroke With HemiparesisMT/PTNCT01586221
Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke
A study testing Music & Physical Therapy in people with Stroke With Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke With Hemiparesis
- What is being tested?
- Music & Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke With Hemiparesis
- Being tested
- Music & Physical Therapy
- Keywords
- Rehabilitation, Fingers, Grasp, Strength, Brain Function, Physiopathology, Functional Laterality, Psychomotor Performance, Biomechanis, Touch, Music Therapy, Weight-Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music & Physical TherapyOther
Participants will receive combined Music Therapy and Physical Therapy for 6 Weeks. Two times per week for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Music & Physical Therapy | Other | Subjects will received Music and Physical Therapy in a group setting. Receives: Other: Music & Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Beginning of study
Secondary outcomes (1)
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
Measured: After completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study start1 Jan 2012
- Primary completionMay 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke With HemiparesisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Sponsor
- Investigators
- Preeti Raghavan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586221
- Sponsor's protocol ID
- 11-02284
- Acronym
- MT/PT
- Status last verified
- Jul 2017
- First submitted
- 9 Apr 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27774059
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke
- ClinicalTrials.gov ID
- NCT01586221
- Acronym / sponsor ID
- MT/PT / 11-02284
- Conditions
- Stroke With Hemiparesis
- Keywords
- Rehabilitation, Fingers, Grasp, Strength, Brain Function, Physiopathology, Functional Laterality, Psychomotor Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- New York University
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music & Physical Therapy | Other | Other: Music & Physical TherapySubjects will received Music and Physical Therapy in a group setting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music & Physical TherapyParticipants will receive combined Music Therapy and Physical Therapy for 6 Weeks. Two times per week for 1 hour. | Other | Music & Physical Therapy |
Primary outcome
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
1 secondary outcome
Hand Function after Therapy
Time frame: After completion of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 27774059Raghavan 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.
Related trials for Stroke With Hemiparesis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
RecruitingObservational study
Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
Stroke, Hemiparesis
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preeti Raghavan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music & Physical Therapy in people with Stroke With Hemiparesis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Base Line Measurement of Hand Function (time frame: Beginning of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01586221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.