A randomised controlled feasibility trial to investigate the effects of a functional standing frame programme versus usual physiotherapy to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke
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Background Task-related training can aid functional recovery post-stroke but has not been investigated in people with severe stroke. Orthostatic hypotension (OH) may limit rehabilitation, therefore, the effects of undertaking prolonged standing and sit to stand repetitions (functional standing frame programme) early after severe stroke during inpatient sub-acute rehabilitation is unknown.
Methods A systematic review of non-pharmacological interventions to treat OH in people with neurological conditions was undertaken to inform a protocol for the management of OH during the functional standing frame programme. The feasibility of a blinded randomised controlled trial (RCT) investigating the effects of a functional standing frame programme compared to usual physiotherapy for people with severe stroke was conducted. Primary (Barthel Index, Edmans ADL Index for Stroke) and secondary outcomes (including lower limb joint range of movement, knee extensor strength, and quality of life) were assessed at baseline, post-intervention and 15-, 29- and 55-weeks post-randomisation. Semi-structured interviews were conducted with a subset of participants, relatives and physiotherapists to explore experiences of the intervention and trial procedures. Data were analysed using thematic analysis and descriptive analysis.
Results The systematic review included randomised controlled trials (n=13), quasiexperimental (n=27), case control (n=1) and case report (n=2). A meta-analysis of seven studies concluded electrical stimulation, lower limb compression and resistance exercise training were favourable in treating or reducing OH. Forty-five participants (51-96 years; 42% male, mRS 4=80% 5=20%) were recruited; n=22 randomised to intervention, n=23 to control. Twenty-seven participants completed the trial: n=12 died (n=7 intervention), n=2 moved out of area, n=4 withdrawn. Adherence to the intervention was low: 38-51% of possible sessions being completed; average session duration 39.40 minutes (±18.8); standing duration 12.52 minutes (±8.8); and mean sit-to-stand repetitions 4.64 (±3.9 SD) per session. 91% of sessions were enjoyed. Adherence was affected by patient, physiotherapist and organisational factors.
Conclusion A definitive RCT of a functional standing frame programme is feasible for people with severe stroke. However, intervention adherence need to be addressed before progressing to a definitive trial, which will investigate clinical and cost effectiveness.
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