Projects per year
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used.
Methods: 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.
Results: 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.
Conclusions: This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used.
Original language | English |
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Article number | 322 |
Journal | Trials |
Volume | 15 |
DOIs | |
Publication status | Published - 12 Aug 2014 |
Profiles
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Garry Barton
- Norwich Medical School - Professor
- Population Health - Member
- Health Economics - Member
- Health Services and Primary Care - Member
- Norwich Clinical Trials Unit - Member
Person: Research Group Member, Research Centre Member, Academic, Teaching & Research
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Allan Clark
- Norwich Medical School - Associate Professor
- Population Health - Member
- Epidemiology and Public Health - Member
- Health Services and Primary Care - Member
- Norwich Clinical Trials Unit - Member
Person: Research Group Member, Research Centre Member, Academic, Teaching & Research
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Jane Cross
- Dementia & Complexity in Later Life - Member
- School of Health Sciences - Associate Professor
- Lifespan Health - Member
- Volunteering and Health and Social Care - Member
- HealthUEA - Steering Committee Member
Person: Research Group Member, Academic, Teaching & Research
Projects
- 1 Finished
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(FEST1vAlS) Functional strength training to improve walking and upper limb function in people at least 1 year after stroke. A phase II trial
Cross, J., Barton, G., Clark, A., McGlashan, K., Poland, F., Pomeroy, V. & Watson, M.
1/01/09 → 31/01/14
Project: Research