Socially Assistive Robot in Upper-Limb Neurorehabilitation: A Long-Term Intervention RCT Using Behavioral Techniques

Randomized Control Trial (RCT) longitudinal Intervention study. The RCT will be in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement . In this study there will be 2 groups of intervention and one control group:

1. Socially Assistive Robotic (SAR) intervention group.
2. Computer intervention group.
3. Control group: standard therapy. Participants A total of 30 subacute, one year post first stroke survivors, age 45-85, females and males, will be randomly allocated into 3 intervention groups. The participants will be recruited from Aleh Negev rehabilitation center, from the ambulatory day care by Dr. Oren Barzel-MD, a Rehabilitation Medicine specialist.

Procedure All patients that will be recruited to the study will be randomly allocated to each of the three intervention groups. The measurements and therapy sessions will take place in Aleh Negev rehabilitation center, in the Day-Care unit, by a physiotherapist and a PhD student from Ben Gurion University (GCP).

Evaluations for all patients will be conducted in three points of time: T1: entrance to the study, before randomization. T2: following 15 intervention sessions (after 5 weeks). T3: one month after end of the intervention. MMSE and FM-UE scores will be recorded as screening tools. FM-UE is a screening tool and a primary outcome measures. At each time point (T1, T2 and T3), the measurements described below will be performed on two separate days to avoid effect of fatigue. Participants will come for a total of 21 sessions: 2 sessions of evaluations, 15 sessions of treatment, 2 sessions of evaluation at the end of the intervention, 2 sessions of evaluations one month post intervention.

Intervention Program The intervention program consists of 15 therapy sessions, 3 times a week, an hour session each time for 5 weeks (over all 15 hours of intervention). Our proposed intervention is a graduated functional RTG games using real objects (like a cup or a jar), in different sizes, shapes, weights, textures and different environments (i.e. different heights or location on the table). The RTG game selected for a participant will be based on the upper limb movement and functional ability of the participant, as was measured by the therapist in the inclusion to the study. The progression will be starting from low table and progressing to higher table, starting from low weights objects (i.e. an empty jar) and progressing to higher weights (i. e. a jar full with flour). Our program is based on two critical parameters of upper limb rehabilitation: 1. the amount of practice-it has been recommended that individuals post-stroke perform as many repetitions per session as they can tolerate . 2. Practicing challenging tasks and not simple repetitive tasks, is likely to elicit motor learning and associated neural reorganization. Since a correlation between cognition and arm motor improvement has been lately described, the games we developed contain upper limb movement as well as cognitive aspects (like working memory). In each meeting the participant will have a one-hour session of RTG games, based on his\ her ability, as was measured upon enrollment in the study and based on his\her fatigue etc. The patient will be able to rest up to 5 minutes between a trial to trial in order to avoid fatigue. In addition, a patient will be able to stop a session at any time if desired. Even though our aim is to evaluate the motivation and performance of the patient outside the individual physiotherapy session with the therapist, we assume that during self-practice at the clinic and at home there is someone with the patient. Therefore during the therapy session of the intervention study a physiotherapist or a student will be present in the room (to help with problems that can arise). All sessions will be filmed and recorded upon agreement of the participant.