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Music Therapy for The Rehabilitation of Upper Limb With Stroke Patients (TIMPStro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310438
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Anglia Ruskin University

Brief Summary:

Impairment of arm function is more common than lower limb impairment in stroke patients and is also more resistant to treatment. Several clinical trials with stroke patients have produced statistically significant gains in upper limb function when using instrumental playing and treatments where rhythm supports the priming and timing of movements. Based on the positive results from controlled and non-controlled trials, the Cochrane review of music therapy for acquired brain injury (Bradt, et al., 2010) recommends further investigation into rhythm based techniques to treat hemiparesis in stroke patients, and that future studies need to examine the relationship between the frequency and duration of interventions and treatment effects.

The aim of this study is to examine whether or not a thirty minute, twice weekly, six week, home music therapy treatment, playing set musical patterns on instruments to music is feasible to deliver, and will lead to improved coordination, dexterity and activities of daily living in hemiparetic stroke patients.

Twelve patients will be recruited from Cambridgeshire Community Services NHS trust (CCS) who are between one month and two years post stroke with hemiparesis. Participants will have completed and been discharged from community rehabilitation for their upper limb and not be receiving any other treatment for arm function. They will be randomised into two groups: treatment (for immediate treatment following discharge from community rehab) and waiting list (beginning 9 weeks after baseline measure). Participants will be assessed at the beginning and end of treatment (just before starting and just after completing 6 weeks of treatment) by one of two experienced community occupational therapists under contract with CCS, who are also experienced in working with stroke patients and who will be blind to the experiment. The other three measures will be conducted by the chief investigator. The assessment tools will be the Action Research Arm Test (ARAT) and nine hole peg test (9HPT). There will also be a pre and post treatment semi-structured interview for each participant, which will be conducted by the chief investigator. ARAT and 9HPT assessments will be administered to all participants at the same time points: baseline and then at week 6, 9, 15 and 18. Data will be analysed to determine if the treatment is effective compared to no treatment (wait list) following community discharge, and whether earlier intervention (treatment group) yields better results for participants, all of whom will eventually receive treatment.


Condition or disease Intervention/treatment Phase
Hemiparesis Other: Therapeutic Instrumental Music Performance Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation Into Music Therapy for Upper Limb Rehabilitation in Stroke Patients
Study Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Early intervention music therapy

music therapy:

6 stroke patients with hemiparesis begin music therapy treatment in their home as soon as they have completed statutory NHS community rehabilitation.

Other: Therapeutic Instrumental Music Performance
The same instruments are selected and used with each participant. They are spatially arranged for them to play in their home in a way that addresses the target movement, for example elbow flexion and extension. The music therapist plays specific musical patterns live on a guitar for each exercise whilst the participant plays specific patterns on the instruments.
Other Name: Music Therapy

Active Comparator: Delayed intervention music therapy

music therapy:

6 stroke patients with hemiparesis begin music therapy treatment in their home 9 weeks after they have been randomised into the wait list group.

Other: Therapeutic Instrumental Music Performance
The same instruments are selected and used with each participant. They are spatially arranged for them to play in their home in a way that addresses the target movement, for example elbow flexion and extension. The music therapist plays specific musical patterns live on a guitar for each exercise whilst the participant plays specific patterns on the instruments.
Other Name: Music Therapy




Primary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: 10 to 30 minutes ]
    The Action Research Arm Test. This includes 19 tasks using the affected and unaffected upper limb, for example picking up a block and placing it on a shelf or pouring water from one cup into another. Each task is timed and scored on a standardised scale (0 to 3). Maximum score of 57.


Secondary Outcome Measures :
  1. The nine hole peg test [ Time Frame: 2 minutes ]
    The secondary outcome measure is the 9 hole peg test (Kellor et al, 1971). This is a test that the Cambridgeshire Community Services team (host to this study) use. It is a timed test measuring finger dexterity using standardised equipment comprising a rectangular plastic tray with a rounded, concave tray at one end containing nine small white pegs and at the other end nine holes into which the participant must (one at a time) place the nine pegs from the tray and then remove them, placing them back into the tray as quickly as possible. The patient practices with the unaffected hand first, then the paretic side. The patient is seated while performing the test. A non-slip mat is placed between the base of the peg test and the table surface. The participant may stabilise the test base if necessary using their unaffected hand. The test takes no more than 2 minutes to administer, depending on the age of the patient and their existing degree of finger dexterity.


Other Outcome Measures:
  1. Semi-structured interview [ Time Frame: 10 minutes ]
    Before beginning the music therapy treatment each participant will be asked set questions about it and to score how much they think it will improve their paretic arm use in activities of daily living. At the end of treatment participants will be asked the same questions. The chief investigator will write down responses during the interview for later thematic analysis. Interviews will not be recorded. Questions have been used that are as open as possible so as to give participants the opportunity to express their preconceptions and thoughts. Each question may lead to further questions, for example question 1 may prompt a response 'I think it will help me" to which the chief investigator may respond "how might it help you?" The purpose of the semi-structured interview is to gather qualitative data specifically regarding how participants experienced the treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. can consent to treatment
  2. aged 18+
  3. has completed community rehabilitation for upper limb paresis
  4. any type and site of stroke
  5. between 3 months and 5 years post stroke
  6. can lift paretic hand onto a table whilst seated, without assistance from unaffected hand
  7. some finger movement, which could be extension of one or more fingers
  8. not receiving any other treatment for upper limb paresis during the course of this study (18 weeks from baseline measure)

Exclusion Criteria:

  1. unable to consent to participate
  2. unable to lift hand up onto a table without assistance
  3. no finger movement
  4. is receiving another treatment for upper limb hemiparesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310438


Locations
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United Kingdom
Anglia Ruskin University
Cambridge, Cambridgeshire, United Kingdom, CB1 1PT
Sponsors and Collaborators
Anglia Ruskin University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT02310438    
Other Study ID Numbers: 13/EE/0400
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by Anglia Ruskin University:
Music therapy
stroke
hemiparesis
neurologic music therapy
Additional relevant MeSH terms:
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Paresis
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms