Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke
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.


Options:
A: The main primary outcome measure is change in the degree of participation measured by the Stroke Impact Scale (SIS, version 2.0.). (At baseline, post intervention and at 3 and 6 months after completion of the intervention period.)
B: Number of persons having cognitively declined at 24 months (24 months after randomization); Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months (24 months after randomization)
C: Paced auditory Serial Attention Test (PASAT) (change from baseline after each 3 treatment sessions, change from baseline after 20 hours of training, change from baseline after 6 months and change from baseline after 1 year); Work Ability Index (WAI) (change from baseline after 20 hours of training, change from baseline after 3 months and change from baseline after 1 year)
D: Change From Baseline in Performance Quality Rating Scale (PQRS) (A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline))

Answer: A