Sensorimotor upper limb therapy does not improve somatosensory function and may negatively interfere with motor recovery: a randomized controlled trial in the early rehabilitation phase after stroke

Question Is sensorimotor upper limb (UL) therapy of more benefit for motor and somatosensory outcome than motor therapy? Design Randomised assessor-blinded multi-centre controlled trial with block randomization stratified for neglect, severity of motor impairment, and type of stroke. Participants 40 first-ever stroke patients with UL sensorimotor impairments admitted to the rehabilitation centre Intervention Both groups received 16 hours of additional therapy over four weeks consisting of sensorimotor (N=22) or motor (N=18) UL therapy. Outcome measures Action Research Arm test (ARAT) as primary outcome, and other motor and somatosensory measures were assessed at baseline, post-intervention and after four weeks follow-up. Results No significant between-group differences were found for change scores in ARAT or any somatosensory measure between the three time points. For UL impairment (Fugl-Meyer assessment), a significant greater improvement was found for the motor group compared to the sensorimotor group from baseline to post-intervention (mean (SD) improvement 14.65 (2.19) versus 5.99 (2.06); p=0.01) and from baseline to follow-up (17.38 (2.37) versus 6.75 (2.29); p=0.003). Conclusion UL motor therapy may improve motor impairment more than UL sensorimotor therapy in patients with sensorimotor impairments in the early rehabilitation phase post stroke. For these patients, integrated sensorimotor therapy may not improve somatosensory function and may negatively influence motor recovery. Trial registration The trial is registered at clinicaltrials.gov [NCT03236376][1]. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial clinicaltrials.gov [NCT03236376][1]. ### Clinical Protocols ### Funding Statement This work was supported by Flanders Research Fund (FWO) (1189819N and 1519719N). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: research has been approved by the ethical committee of UZ/KU Leuven All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes data is available from the corresponding author upon reasonable request [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03236376&atom=%2Fmedrxiv%2Fearly%2F2020%2F09%2F18%2F2020.09.15.20194845.atom