Music Therapy for The Rehabilitation of Upper Limb With Stroke Patients

NCT02310438 | Completed Phase 2

• 1 other identifier: 13/EE/0400
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis

Keywords

Music therapy; stroke; hemiparesis; neurologic music therapy

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test (ARAT)

  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.

  10 to 30 minutes

Secondary Outcomes (1)

• The nine hole peg test

  2 minutes

Other Outcomes (1)

• Semi-structured interview

  10 minutes

Study Arms (2)

Early intervention music therapy

EXPERIMENTAL

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

Delayed intervention music therapy

ACTIVE COMPARATOR

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

Interventions

Therapeutic Instrumental Music Performance OTHER

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.

Also known as: Music Therapy

Delayed intervention music therapy; Early intervention music therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable to consent to participate
• unable to lift hand up onto a table without assistance
• no finger movement
• is receiving another treatment for upper limb hemiparesis

Sponsors & Collaborators

• Anglia Ruskin University: lead

Study Sites (1)

Anglia Ruskin University

Cambridge, Cambridgeshire, CB1 1PT, United Kingdom

Location

Related Publications (1)

• Street AJ, Magee WL, Bateman A, Parker M, Odell-Miller H, Fachner J. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):18-28. doi: 10.1177/0269215517717060. Epub 2017 Jun 23.

  PMID: 28643570 DERIVED

MeSH Terms

Conditions

Paresis; Stroke

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

GB (1)