Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial.

BACKGROUND: Stroke patients are often affected by arm paresis, have functional impairments and receive help from professional or informal caregivers. Progressive resistance training is a common intervention for functional impairments after paresis. Randomised controlled trials (RCT) showed benefits for functional recovery after resistance training. However, there is a lack of evidence for strength training in subacute stroke patients. The aim of this study is to investigate safety and effectiveness of arm strength training in subacute stroke patients. METHODS: We will conduct a prospective, assessor-blinded RCT of people with subacute stroke. We will randomly assign patients to one of two parallel groups in a 1:1 ratio and will use concealed allocation. The intervention group will receive, in addition to standard treatment, high-intensity arm training (three times per week, over three weeks; 60 min each session; with a total of nine additional sessions). The control group will receive, in addition to standard treatment, low-intensity arm training (same quantity, frequency and treatment time as the intervention group). Standard treatment for the affected arm includes mobilisation, stretching, therapeutic positioning, arm and hand motor training, strengthening exercises, mechanical assisted training, functional training and task-oriented training. The primary efficacy endpoint will be grip strength. Secondary outcome measures will be Modified Ashworth Scale, Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test and Goal Attainment Scale for individual participatory goals. We will measure primary and secondary outcomes with blinded assessors at baseline and immediately after three weeks of additional therapy. Based on our sample size calculation, 78 patients will be recruited from our rehabilitation hospital in two and a half years. Drop-out rates and adverse events will be systematically recorded. DISCUSSION: This study attempts to close the evidence gap for effects of arm strength training in subacute stroke patients. The results of this trial will provide robust evidence for effects and safety of high-intensity arm training for people with stroke. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00012484 . Registered on 26 May 2017.

A new orthosis for subluxed, flaccid shoulder after stroke facilitates gait symmetry: a preliminary study.

OBJECTIVE: The aims of this study were: (i) to evaluate the immediate effects on subluxation and gait pattern of a new shoulder orthosis, developed for treatment of painful shoulder syndrome in subacute stroke patients; and (ii) to evaluate patients' and therapists' opinions about its fit and benefits after 4 weeks. METHODS: A total of 40 subacute in-rehabilitation stroke patients with non-functional arm and painful shoulder were included in the study. Of these, 12 subjects underwent shoulder radiography and gait analysis with and without the orthosis to determine the immediate effects of the orthosis. All 40 patients wore the orthosis during the daytime for 4 weeks before completing a survey. Outcome measures were: repositioning of the humeral head, gait cycle parameters, and qualitative lower limb muscle activation patterns. Patients and therapists rated wearing comfort, odour nuisance, effect on pain and performing gait and mobility-related activities. RESULTS: When using the shoulder orthosis the humeral head was repositioned in 10 of 12 patients, patients walked more symmetrically due to a prolonged hemiparetic stance phase (p < 0.01), and the paretic quadriceps muscle activity was higher and more appropriately timed. The majority of patients and therapists rated the wearing comfort positive, the odour nuisance minimal, and that the orthosis helped with performing activities. However, less than half of patients and therapists reported improvement in pain. CONCLUSION: The well-tolerated shoulder orthosis improved gait quality and repositioned the subluxated humeral head, offered a good fit, and eased performing activities, but did not reduce pain. This preliminary study does not warrant any definite conclusions on the effectiveness of the orthosis; more studies are needed to compare its effect with other models.