High-intensity upper limb rehabilitation training in sub-acute stroke survivors in a low-resource setting: The HUTS trial - an RCT.

This prospective, assessor-blinded RCT on subacute stroke survivors. The study aims to understand the effect of high-intensity, high-dose upper limb training compared to usual care. To overcome the main drawbacks of a low-resource setting (financial resources, manpower and time), the protocol involves caregivers in the intervention protocol to both train them and reduce the financial and manpower-related workload. The patients will be assigned to the intervention group or active control group in a 1:1 ratio. The intervention group will receive high-intensity upper limb training i.e. 180mins/day for 6 days/week for 3 weeks and the active-control group will receive 60mins/day for 6 days/week for 3 weeks. For both groups, caregivers will provide intervention for 1/3 of the total therapy time i.e. 60 minutes for the intervention group and 20 minutes for the active control group.  At baseline and every week till 3 weeks of intervention, the Fugl Meyer Assessment for Upper Extremity (FMA-UE) will be done for every participant.

The intervention protocol will be the same for both the intervention group and active-control group, the intervention group will receive a higher number of repetitions. The treating therapist will be provided with a manual and exercise video which will be the same for both groups, the only difference will be the dose and intensity. The exercises will be initiated according to the patient’s status and goal. For the caregiver training, the caregiver will be provided with a manual/videos or photos where the therapist will decide the exercises that have to be conducted bedside. The caregiver will be explained in detail. The first two days of training will happen under the supervision of the therapist. After this, the therapist will review the exercises daily, progress the exercises accordingly and clear if any doubts arise.