StrokeNCT01372059
The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke
A study testing RGRM and Therapeutic riding in people with Stroke, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- RGRM and Therapeutic riding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to 2 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- RGRM, Therapeutic riding, Receives no intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGRMOther
Also called The Ronnie Gardiner Rhythm Music Method (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.
Therapeutic ridingOther
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 interventionOther
Also called No intervention in phase one
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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).
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Perceived mental functioning: Change in perceived mental functioning is assessed using the Montgomery-Åsberg Depression Rating Scale - self rate (MADRS-S)
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Cognitive function: Change in psycho-motor speed and selective attention is assessed using the Ruff 2 & 7 selective attention test.
Measured: At baseline, post intervention and at 6 months after completion of the intervention period.
Cognitive function: Change in working memory assessed using the Letter-Number Sequencing (LNS) and the subtest Digit spanin Wechsler Adult Intelligence Scale (WAIS-III)
Measured: At baseline, post intervention and at 6 months after completion of the intervention period.
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.
Measured: At baseline, post intervention and at 6 months after completion of the intervention period.
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.
Measured: At baseline, post intervention and at 6 months after completion of the intervention period.
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).
Measured: At baseline, post intervention and at 6 months after completion of the intervention period.
Changes in experienced tiredness using a Visual Analogue Scale (VAS) pre-and post testing.
Measured: At baseline, post intervention and at 6 months after completion of the intervention period.
Body function: Change in upper limb function is determined using the Action Research Arm Test (ARAT).
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
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.
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
Body structure: Change in the analyses of biomarkers, growth factors and inflammatory markers.
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Activity: Change in perceived confidence in task performance is measured with the Swedish modification of the Falls-Efficacy Scale - FES (S).
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Activity: Change in motor recovery is assessed using the Modified Motor Assessment Scale according to the Uppsala University hospital (M-MAS UAS).
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
Activity: Change in balance is evaluated by two measures: 1) the Berg Balance Scale (BBS) and 2) (Bäckstrand, Dahlberg, and Liljenäs) BDL balance scale
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
Activity: Change in mobility is measured by the Timed "up and Go" (TUG).
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
For this study's exploratory purpose both individual interview and focus groups methodology are used.
Measured: When treatment is finalized
Activity: To measure gait speed the timed 10 meter walk test (10MWT) is used
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Activity: Change in walking capacity is measured using the 6-minute walk test (6MWT).
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
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.
Measured: Evaluation is conducted at baseline, following the 12-week intervention period, and six months after completion of the intervention period.
Environmental factors: Change in the life situation among the spouses is evaluated by the Life Situation among spouses after the Stroke event questionnaire (LISS).
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Personal factors: Change in the participants' ability to cope with stress is assessed using The Sense of Coherence (SOC) scale.
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Activity: To measure gait speed the timed 10 meter walk test (10MWT) was used
Measured: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJan 2010
- Primary completion30 May 2014
- Study completion2 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Sten A Olsson foundation for Research and Culture
- Responsible party
- Sponsor
- Investigators
- Christian Blomstrand, Professor, Study chair, Göteborg UniversityLina Bunketorp Kall, Ph. D., Study chair, Göteborg UniversityMichael Nilsson, Professor, Principal investigator, Göteborg UniversityÅsa Lundgren Nilsson, Ph. D., Study chair, Göteborg UniversityMilos Pekny, Professor, Study chair, Göteborg UniversityMarcela Pekna, Ass prof, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372059
- Sponsor's protocol ID
- B41-f 1027/09
- Status last verified
- Apr 2019
- First submitted
- 26 May 2011
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28619985Bunketorp 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.
PubMed 23171380
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke
- ClinicalTrials.gov ID
- NCT01372059
- Acronym / sponsor ID
- B41-f 1027/09
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Sten A Olsson foundation for Research and Culture
- Study start
- Jan 2010
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 2 Jun 2014 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rhythm and music therapy | Experimental | Other: RGRMSince 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. |
| Therapeutic riding | Active comparator | Other: Therapeutic ridingTherapeutic 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. |
| Receives no intervention | Other | Other: Receives no interventionReceives 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGRMAlso: The Ronnie Gardiner Rhythm Music Method (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 | Rhythm and music therapy |
| Therapeutic ridingThe 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 | Therapeutic riding |
| Receives no interventionAlso: No intervention in phase oneReceives 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 |
Primary outcome
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.
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.
26 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
For this study's exploratory purpose both individual interview and focus groups methodology are used.
Time frame: When treatment is finalized
Activity: To measure gait speed the timed 10 meter walk test (10MWT) is used
Time frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
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.
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.
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.
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.
Activity: To measure gait speed the timed 10 meter walk test (10MWT) was used
Time frame: At baseline, post intervention and at 3 and 6 months after completion of the intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 28619985Bunketorp-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.
- Derived from this study: PubMed 23171380Bunketorp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Blomstrand, Professor study chair
Göteborg University
Lina Bunketorp Kall, Ph. D. study chair
Göteborg University
Michael Nilsson, Professor principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGRM and Therapeutic riding in people with Stroke, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01372059, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.