Dose-Response Study of Mobilisation and Tactile Stimulation Therapy for the Upper Extremity Early After Stroke: A Phase I Trial

Background. Physical therapy doses may need to be higher than provided in current clinical practice, especially for patients with severe paresis. The authors aimed to find the most effective and feasible dose of Mobilisation and Tactile Stimulation (MTS), which includes joint and soft-tissue mobilization and passive or active-assisted movement to enhance voluntary muscle contraction. Methods. This 2-center, randomized, controlled, observer-blinded feasibility trial compared conventional rehabilitation but no extra therapy (group 1) with conventional therapy plus 1 of 3 daily doses of MTS, up to 30 (group 2), 60 (group 3), or 120 (group 4) minutes for 14 days. The 76 participants had substantial paresis (Motricity Index [MI] < 61) a mean of 30 days (standard deviation [SD] = 20 days) after anterior circulation stroke. MTS was delivered using a standardized schedule of techniques (eg, sensory input, active-assisted movement). The primary outcome was the Motricity Index (MI) and secondary outcome was the Action Research Arm Test (ARAT) tested on day 16. Adverse events were monitored daily. Results. No difference was found in the change in control group MI compared with each of the 3 intervention groups (P = .593) or in the ARAT. Mean actual daily treatment time for all MTS groups was less than expected. The attrition rate was 1.3%. No adverse events related to overuse occurred. Conclusion. The authors were not able to deliver a maximum dose of 120 minutes of daily therapy each day. The mean daily dose of MTS feasible for subsequent evaluation is between 37 and 66 minutes.