Effects of intensive multidimensional trunk training exercises combined with dual-task compared to routine physiotherapy on balance, mobility, and fall in stroke patients; a randomized controlled clinical trial

To determine the effects of intensive multidimensional trunk training exercises combined with dual-task compared to routine physiotherapy on balance, mobility and fall risk in stroke patients

Randomised, superiority, parallel-group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. The sample size was 84 out of which 74 patients completed the study.

Patients were recruited from the University clinic of the University of Lahore, a 400-bed hospital with separate physiotherapy and stroke rehabilitation facility. It was single-blinded (assessor blinded) study

Inclusion criteria: Patient with an ability to stand 30 seconds or more without any assistance, score 24 or over on mini-mental status examination, and ability to sit independently at least for 30 seconds on a stable surface. Exclusion criteria: Patients with comorbid conditions such as cerebellar disorders, Parkinson's disease, a vestibular lesion, arthritis or degenerative diseases of the lower limbs affecting motor performance, self-reported problems with device use (orthopaedic, medical, and/or painful conditions), a body mass index greater than 31 kg/m 2 who are not able to perform exercises for 30 minutes or longer, any medical contraindication against trunk exercise and patient with pusher syndrome.

Intervention group: multidimensional trunk exercises combined with dual-task, flexibility and task-oriented exercises Comparison group: trunk exercises, flexibility and task-oriented exercises

Balance & mobility measured with time up and go test, timed walking test, go up and down standard 10 stairs, trunk performance measured with trunk impairment scale, and fall risk measured with fall risk assessment tool.

Randomisation was centralised and computerised with concealed randomisation sequence in an enclosed envelope carried out at an external site by independent personnel.

Independent assessors, who were not familiar with the aims and objectives of the study, assessed & evaluated the patients' outcomes. Furthermore, all trial participants were informed about blind outcome assessments and its importance and requested not to reveal their group allocation on the following occasions: 1. Baseline assessment; both immediately prior to, and after, randomization. 2. On each time when participants were requested to arrange follow-up visits. 3. At the commencement of each follow-up visit The outcome assessor had no access to any study data and therapist/personnel involved in the study, no access to the password-protected study database controlled by the Data Safety and Monitoring Board and no access to completed assessments, treatment notes or questionnaires. The follow-up questionnaire item was used to measure outcome assessor’s awareness of group allocation during follow-up visits. Therapists who provided the care to the patients were unaware of the identity of the assessors. If any support were needed to therapist and assessors, the lead research was responsible to provide all the guidance to them in strict accordance with the Data Safety and Monitoring Board. The Board does not allow the lead researcher to have direct contact and meet with the assessors anywhere except permitted site. In case of provision of any support, he had to provide video-recorded evidence of the support given to the assessors to prevent the breach in blinding. Data analyser was kept blinded by coding groups, participants and their assessments, and he did not have any direct or indirect access to the patients or personnel involved in the study. He was also completely unaware of the aims & objectives of the study.