The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke

Göteborg University

Status: Completed

Conditions: Stroke

Treatments: Other: RGRM; Other: Therapeutic riding; Other: Receives no intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01372059

B41-f 1027/09

Details and patient eligibility

About

The initiative to the study is based on the fact that various forms of enriched environments and multimodal stimulation are found to have positive influences on motivation and psychosocial well-being and have been shown to facilitate multiple processes in the brain leading to structural regeneration and functional recovery. Since there is a lack of rehabilitation programs that encompass all dimensions of a stroke survivor's life researchers agree upon the need for a rehabilitation program that addresses both the social and physical needs of the patients. The aim with the project is to investigate whether it is possible to improve the life situation among patients with a history of stroke through a rhythm and music method and therapeutic riding. To get insights in the underlying mechanisms our research also focuses on relevant physiological, neurobiological and psychosocial mechanisms induced by the interventions. The hypothesis is that both treatment methods will mainly enhance participants' degree of participation.

The study is a randomized controlled trial where about 123 participants (50-75 years old) who had their stroke incident 1 - 5 years ago will be consecutively included and randomly allocated to the following three groups: a) Ronnie Gardiner Rhythm Music Method (RGRM) b) therapeutic riding c) a control group receiving RGRM after 9 months. Treatment proceeds during 12 weeks and evaluation takes place pre- and post intervention, and 12 and 24 weeks after the treatment is finalized. The evaluation consists of a thorough neuropsychological assessment, a physiotherapeutic assessment, sampling of blood and questionnaires covering mental, psychosocial, physical and psychological well-being. Interviews are also conducted in order to map the participants' experiences from the two treatment programs. Specially designed interviews are also planned to be carried through with participants having aphasia.

So far, there is only empirical support suggesting that RGRM has positive effects for individuals with a history of stroke making it significant to carry out research with the aim to contribute to strengthening the evidence of the method. A positive outcome would increase the scientific basis for this alternative treatment thus facilitating further research and implementation in everyday clinical practice.

Full description

Background and Purpose: Treatments that improve function in late phase after stroke are urgently needed. We assessed whether multimodal interventions based on rhythm-and-music therapy or horse-riding therapy could lead to increased perceived recovery and functional improvement in a mixed population of individuals in late phase after stroke.

Methods: Participants were assigned to rhythm-and-music therapy, horse-riding therapy, or control using concealed randomization, stratified with respect to sex and stroke laterality. Therapy was given twice a week for 12 weeks. The primary outcome was change in participants' perception of stroke recovery as assessed by the Stroke Impact Scale with an intention-to-treat analysis. Secondary objective outcome measures were changes in balance, gait, grip strength, and cognition. Blinded assessments were performed at baseline, postintervention, and at 3- and 6-month follow-up.

Results: One hundred twenty-three participants were assigned to rhythm-and-music therapy (n=41), horse-riding therapy (n=41), or control (n=41). Post-intervention, the perception of stroke recovery (mean change from baseline on a scale ranging from 1 to 100) was higher among rhythm-and-music therapy (5.2 [95% confidence interval, 0.79-9.61]) and horse-riding therapy participants (9.8 [95% confidence interval, 6.00-13.66]), compared with controls (-0.5 [-3.20 to 2.28]); P=0.001 (1-way ANOVA). The improvements were sustained in both intervention groups 6 months later, and corresponding gains were observed for the secondary outcomes.

Conclusions: Multimodal interventions can improve long-term perception of recovery, as well as balance, gait, grip strength, and working memory in a mixed population of individuals in late phase after stroke.

Enrollment: 123 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 50 - 75 years
• Disability grade 2 or 3 on MRS*)
• Being in the late-phase of stroke (1 - 5 years after an ischemic or hemorrhagic stroke)
• Ability to understand written and oral information and instructions in Swedish
• Having an own housing
• Ability to travel to the place of intervention and evaluation
• No need for personal assistance in activities of daily living while participating in the treatment (going to the toilet, transport/transportation services for disabled, walking)

Exclusion criteria

• Disability rated ˂ 2 or ˃ 3 on MRS*)
• Pronounced fear of horses or allergy constituting a risk for the patients to participate in the therapeutic riding
• Heart conditions that constitutes a risk for the individual to participate in the interventions
• Non-controlled epileptic seizures constituting a risk for the patients to participate in the intervention
• Lack of cognitive and/or verbal ability that makes it difficult for the individual to understand instructions and/or evaluation
• Total paralysis of the affected arm
• Injury or disease that makes the individual not suitable for the trial
• Weight ˃ 95 kg (in order to spare the horses)
• Having more than a half-time employment
• Injury, disease or addiction that make the individual not suitable for the trial
• Participation in RGRM or therapeutic riding during the year prior to inclusion
• Having an additional stroke within the past year (TIA is however accepted)
• Lack of willingness to participate in both treatment methods
• Living ˃ 80 km from Gothenburg
• Dependent on transportation services for disabled across the community border which is not allowed according to the regulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

Rhythm and music therapy

Experimental group

Description:

Since 1993 The RGRM Method is a concept launched in both health and medical care. The method is mainly designed to help people with injuries and diseases of the central nervous system.

Treatment:

Other: RGRM

Therapeutic riding

Active Comparator group

Description:

Therapeutic riding can be useful for individuals with neurological and muscular impairments. The goal of therapeutic riding as professional treatment is to improve neurological functioning and to achieve functional gains and enhance life skills.

Treatment:

Other: Therapeutic riding

Receives no intervention

Other group

Description:

Receives no intervention and acts as a control group in the analyses but will receive rhythm and music therapy after one year, when the long-term follow-up is completed.

Treatment:

Other: Receives no intervention