Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial
1 School of Rehabilitation Sciences, Queen’s Building, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK
2 Norwich Medical School and Norwich Clinical Trials Unit, University of East Anglia, Norwich NR4 7TJ, UK
3 Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK
4 Colman Centre for Specialist Rehabilitation Services, Unthank Road, Norwich NR2 2PJ, UK
5 School of Medicine & Dentistry, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK and Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK
6 Department of Sports Therapy and Physiotherapy, Faculty of Health and Social Sciences, University of Bedfordshire, Park Square, Luton LU1 3JU, UK
Trials 2014, 15:322 doi:10.1186/1745-6215-15-322Published: 12 August 2014
Functional Strength Training (FST) could enhance recovery late after stroke. The aim of this study was to evaluate the feasibility of a subsequent fully powered, randomized controlled trial.
The study was designed as a randomized, observer-blind trial. Both interventions were provided for up to one hour a day, four days a week, for six weeks. Evaluation points were before randomization (baseline), after six weeks intervention (outcome), and six weeks thereafter (follow-up). The study took place in participants’ own homes. Participants (n = 52) were a mean of 24.4 months after stroke with a mean age of 68.3 years with 67.3% male. All had difficulty using their paretic upper (UL) and lower limb (LL). Participants were allocated to FST-UL or FST-LL by an independent randomization service. The outcome measures were recruitment rate, attrition rate, practicality of recruitment strategies, occurrence of adverse reactions, acceptability of FST, and estimation of sample size for a subsequent trial. Primary clinical efficacy outcomes were the Action Research Arm Test (ARAT) and the Functional Ambulation Categories (FAC). Analysis was conducted using descriptive statistics and thematic analysis of participants’ views of FST. A power calculation used estimates of clinical efficacy variance to estimate sample size for a subsequent trial.
The screening process identified 1,127 stroke survivors of whom 52 (4.6%) were recruited. The recruitment rate was higher for referral from community therapists than for systematic identification of people discharged from an acute stroke unit. The attrition rate was 15.5% at the outcome and follow-up time-points. None of the participants experienced an adverse reaction. The participants who remained in the study at outcome had received 68% of the total possible amount of therapy. Participants reported that their experience of FST provided a sense of purpose and involvement and increased their confidence in performing activities. The power calculation provides estimation that 150 participants in each group will be required for a subsequent clinical trial.
This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used.
Controlled-trials.com ISRCTN71632550, 30 January 2009.