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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Göteborg University
Sponsor:
Collaborator:
The Sten A Olsson foundation for Research and Culture
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01372059
First received: May 26, 2011
Last updated: May 5, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Other: RGRM
Other: Therapeutic riding
Other: Receives no intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • The main primary outcome measure is change in the degree of participation measured by the Stroke Impact Scale (SIS, version 2.0.). [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Self-reported fatigue assessed by Fatigue Impact Scale [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
    The secondary outcome measures are grouped within the following domains: 1. Self-reported fatigue; 2. Body functions and structure; 3. Activity; 4. Environmental and; 5. Personal factors.Outcomes will be analyzed in terms of change from baseline to three, six and nine months.

  • Participation: Change in life satisfaction measured using the Life Satisfaction Checklist - LiSat-9 [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Participation: Change in health-related quality of life is measured using the EuroQol (EQ-5D) [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Perceived mental functioning: Change in perceived mental functioning is assessed using the Montgomery-Åsberg Depression Rating Scale - self rate (MADRS-S) [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Cognitive function: Change in psycho-motor speed and selective attention is assessed using the Ruff 2 & 7 selective attention test. [ Time Frame: At baseline, post intervention and at 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Cognitive function: Change in working memory assessed using the Letter-Number Sequencing (LNS) and the subtest Digit spanin Wechsler Adult Intelligence Scale (WAIS-III) [ Time Frame: At baseline, post intervention and at 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Cognitive function: Change in alertness, simple psycho-motor speed and working memory is assessed using the computerized "Test for Attentional Performance" or TAP and TAP-M (mobility version)- battery. [ Time Frame: At baseline, post intervention and at 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Cognitive function: Change in non-verbal learning - of visual patterns is evaluated by the Non-verbal Learning Test (NVLT) included in the computerized Vienna Test System. [ Time Frame: At baseline, post intervention and at 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Cognitive function: Change in general cognitive level and of language, visuospatial function, memory, and attention is done using the BNI Screen for Higher Cerebral Functions (BNIS). [ Time Frame: At baseline, post intervention and at 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Changes in experienced tiredness using a Visual Analogue Scale (VAS) pre-and post testing. [ Time Frame: At baseline, post intervention and at 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Body function: Change in upper limb function is determined using the Action Research Arm Test (ARAT). [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Body function: Change in grip strength is measured using a Grippit® instrument (AB Detektor, Göteborg, Sweden), a portable instrument designed for measuring isometric grip strength. [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Body structure: Change in the analyses of biomarkers, growth factors and inflammatory markers. [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Activity: Change in perceived confidence in task performance is measured with the Swedish modification of the Falls-Efficacy Scale - FES (S). [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Activity: Change in motor recovery is assessed using the Modified Motor Assessment Scale according to the Uppsala University hospital (M-MAS UAS). [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Activity: Change in balance is evaluated by two measures: 1) the Berg Balance Scale (BBS) and 2) (Bäckstrand, Dahlberg, and Liljenäs) BDL balance scale [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Activity: Change in mobility is measured by the Timed "up and Go" (TUG). [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Activity: Change in walking capacity is measured using the 6-minute walk test (6MWT). [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Activity: Change in the level of dependence/independence in personal and instrumental activities of daily living among the participants is evaluated by the ADL Staircase. [ Time Frame: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Environmental factors: Change in the life situation among the spouses is evaluated by the Life Situation among spouses after the Stroke event questionnaire (LISS). [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • Personal factors: Change in the participants' ability to cope with stress is assessed using The Sense of Coherence (SOC) scale. [ Time Frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period. ] [ Designated as safety issue: No ]
  • For this study's exploratory purpose both individual interview and focus groups methodology are used. [ Time Frame: When threatment is finalized ] [ Designated as safety issue: No ]

Estimated Enrollment: 123
Study Start Date: January 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rhytm 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.
Other: 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.
Other Name: The Ronnie Gardiner Rhythm Music Method (RGRM)
Active Comparator: 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.
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.
Other Name: Therapeutic riding
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.
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.
Other Name: No intervention in phase one

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372059

Contacts
Contact: Lina Bunketorp Kall, Ph. D. +46 31 786 34 37 lina.bunketorp@neuro.gu.se

Locations
Sweden
Sahlgrenska University hospital / Högsbo Recruiting
Gothenburg, Sweden
Contact: Lina Bunketorp Käll, Ph. D.    +46 31 786 34 37    lina.bunketorp@neuro.gu.se   
Principal Investigator: Michael Nilsson, Professor         
Sponsors and Collaborators
Göteborg University
The Sten A Olsson foundation for Research and Culture
Investigators
Study Chair: Christian Blomstrand, Professor Göteborg University
Study Chair: Lina Bunketorp Kall, Ph. D. Göteborg University
Principal Investigator: Michael Nilsson, Professor Göteborg University
Study Chair: Åsa Lundgren Nilsson, Ph. D. Göteborg University
Study Chair: Milos Pekny, Professor Göteborg University
Study Chair: Marcela Pekna, Ass prof Göteborg University
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01372059     History of Changes
Other Study ID Numbers: B41-f 1027/09
Study First Received: May 26, 2011
Last Updated: May 5, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014