Stroke Clinical Trial
Official title:
The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
| Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
| Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
| Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
| Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
| Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
| Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
| Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
| Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
| Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
| Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
| Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
| Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
| Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
| Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
| Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
| Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
| Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|