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

NCT ID: NCT01372059

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-06-02

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rhythm and music therapy

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.

Group Type: EXPERIMENTAL

RGRM

Intervention Type: OTHER

RGRM is multi-sensory method. The group including 6-8 participants is headed by a certified therapist of the method using a unique note system. The Note system is the combined body of body symbols in red and blue, with the audio codes and movements and be assembled in countless combinations to stimulate different parts of the brain. The movements are exercised by the hands tapping on the knees and feet stamping on the floor without the need for tools other than the body. The RGRM is developed to stimulate mobility, reading and speech, rhythm-esteem, body image, balance, memory, coordination, motor skills, concentration, perseverance and social skills. The group will have two sessions per week during 12 weeks.

Therapeutic riding

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.

Group Type: ACTIVE_COMPARATOR

Therapeutic riding

Intervention Type: OTHER

The horses walk provides sensory input through movement, which is variable, rhythmic, and repetitive. The many textures, sounds, sights, movement experiences of working around a horse provide an enriched sensory environment. The participants gain from the physical benefits of being on a moving horse and are socially and emotionally stimulated by interacting with a horse and the rest of the group. The intervention is headed by educated therapists (occupational therapist and physical therapist), in conjunction with experienced horse handler and specially trained therapy horses. The treatment is held in group format (4-6 participants) twice per week in 12 weeks which runs in sessions where two participants ride at the same time.

Receives no intervention

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.

Group Type: OTHER

Receives no intervention

Intervention Type: OTHER

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.

Interventions

RGRM

RGRM is multi-sensory method. The group including 6-8 participants is headed by a certified therapist of the method using a unique note system. The Note system is the combined body of body symbols in red and blue, with the audio codes and movements and be assembled in countless combinations to stimulate different parts of the brain. The movements are exercised by the hands tapping on the knees and feet stamping on the floor without the need for tools other than the body. The RGRM is developed to stimulate mobility, reading and speech, rhythm-esteem, body image, balance, memory, coordination, motor skills, concentration, perseverance and social skills. The group will have two sessions per week during 12 weeks.

Intervention Type: OTHER

Therapeutic riding

The horses walk provides sensory input through movement, which is variable, rhythmic, and repetitive. The many textures, sounds, sights, movement experiences of working around a horse provide an enriched sensory environment. The participants gain from the physical benefits of being on a moving horse and are socially and emotionally stimulated by interacting with a horse and the rest of the group. The intervention is headed by educated therapists (occupational therapist and physical therapist), in conjunction with experienced horse handler and specially trained therapy horses. The treatment is held in group format (4-6 participants) twice per week in 12 weeks which runs in sessions where two participants ride at the same time.

Intervention Type: OTHER

Receives no intervention

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.

Intervention Type: OTHER

Other Intervention Names

The Ronnie Gardiner Rhythm Music Method (RGRM); No intervention in phase one

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Sten A Olsson foundation for Research and Culture

UNKNOWN

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Blomstrand, Professor

Role: STUDY_CHAIR

Göteborg University

Lina Bunketorp Kall, Ph. D.

Role: STUDY_CHAIR

Göteborg University

Michael Nilsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Åsa Lundgren Nilsson, Ph. D.

Role: STUDY_CHAIR

Göteborg University

Milos Pekny, Professor

Role: STUDY_CHAIR

Göteborg University

Marcela Pekna, Ass prof

Role: STUDY_CHAIR

Göteborg University

Locations

Sahlgrenska University hospital / Högsbo

Gothenburg, , Sweden

Countries

Sweden

References

Bunketorp-Kall L, Lundgren-Nilsson A, Samuelsson H, Pekny T, Blomve K, Pekna M, Pekny M, Blomstrand C, Nilsson M. Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke: A Randomized Controlled Trial. Stroke. 2017 Jul;48(7):1916-1924. doi: 10.1161/STROKEAHA.116.016433. Epub 2017 Jun 15.

Reference Type: DERIVED

PMID: 28619985 (View on PubMed)

Bunketorp Kall L, Lundgren-Nilsson A, Blomstrand C, Pekna M, Pekny M, Nilsson M. The effects of a rhythm and music-based therapy program and therapeutic riding in late recovery phase following stroke: a study protocol for a three-armed randomized controlled trial. BMC Neurol. 2012 Nov 21;12:141. doi: 10.1186/1471-2377-12-141.

Reference Type: DERIVED

PMID: 23171380 (View on PubMed)

Other Identifiers

B41-f 1027/09

Identifier Type: -

Identifier Source: org_study_id