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

NCT01372059 | Completed DMC

• 1 other identifier: B41-f 1027/09
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• The main primary outcome measure is change in the degree of participation measured by the Stroke Impact Scale (SIS, version 2.0.).

  Based on the Classification of Functioning, Disability, and Health (ICF) the outcome measures are classified into 6 comprehensive domains, with participation being the primary outcome measure. Other primary outcome measures within the participation domain are Life satisfaction checklist, EuroQol and the psychosocial subscale of Fatigue Impact Scale.Outcomes will be analyzed in terms of change from baseline to three, six and nine months.

  At baseline, post intervention and at 3 and 6 months after completion of the intervention period.

Secondary Outcomes (26)

• Change in Self-reported fatigue assessed by Fatigue Impact Scale

  At baseline, post intervention and at 3 and 6 months after completion of the intervention period.

• Participation: Change in life satisfaction measured using the Life Satisfaction Checklist - LiSat-9

  At baseline, post intervention and at 3 and 6 months after completion of the intervention period.

• Participation: Change in health-related quality of life is measured using the EuroQol (EQ-5D)

  At baseline, post intervention and at 3 and 6 months after completion of the intervention period.

• Self-reported fatigue: Change in the impact of fatigue on common daily activities and on health-related quality of life is measured with the Fatigue Impact Scale (FIS).

  At baseline, post intervention and at 3 and 6 months after completion of the intervention period.

• Perceived physical functioning: Change in optimistic self-beliefs to cope with a variety of difficult demands in life are assessed using the General Self-Efficacy Scale (GSES).

  At baseline, post intervention and at 3 and 6 months after completion of the intervention period.

Study Arms (3)

Rhythm and music therapy

EXPERIMENTAL

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.

Other: RGRM

Therapeutic riding

ACTIVE COMPARATOR

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.

Other: Therapeutic riding

Receives no intervention

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.

Other: Receives no intervention

Interventions

RGRM 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.

Also known as: The Ronnie Gardiner Rhythm Music Method (RGRM)

Rhythm and music therapy

Therapeutic riding 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.

Therapeutic riding

Receives no intervention 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.

Also known as: No intervention in phase one

Receives no intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Göteborg University: lead
• The Sten A Olsson foundation for Research and Culture: collaborator

Study Sites (1)

Sahlgrenska University hospital / Högsbo

Gothenburg, Sweden

Location

Related Publications (2)

• 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.

  PMID: 28619985 DERIVED

• 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.

  PMID: 23171380 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Clinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christian Blomstrand, Professor

  Göteborg University

  STUDY CHAIR

• Lina Bunketorp Kall, Ph. D.

  Göteborg University

  STUDY CHAIR

• Michael Nilsson, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

• Åsa Lundgren Nilsson, Ph. D.

  Göteborg University

  STUDY CHAIR

• Milos Pekny, Professor

  Göteborg University

  STUDY CHAIR

• Marcela Pekna, Ass prof

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 13, 2011
• Study Start: January 1, 2010
• Primary Completion: May 30, 2014
• Study Completion: June 2, 2014
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

SE (1)