Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Abstract

BackgroundRepetitive functional task practise (RFTP) is a promising treatment to improve upper limb recovery following stroke. We report the findings of a study to determine the feasibility of a multi-centre randomised controlled trial to evaluate this intervention.MethodsA pilot randomised controlled trial recruited patients with new reduced upper limb function within 14 days of acute stroke from three stroke units. Participants were randomised to receive a four week upper limb RFTP therapy programme consisting of goal setting, independent activity practise, and twice weekly therapy reviews in addition to usual post stroke rehabilitation, or usual post stroke rehabilitation. The recruitment rate; adherence to the RFTP therapy programme; usual post stroke rehabilitation received; attrition rate; data quality; success of outcome assessor blinding; adverse events; and the views of study participants and therapists about the intervention were recorded.ResultsFifty five eligible patients were identified, 4-6 % of patients screened at each site. Twenty four patients participated in the pilot study. Two study sites met the recruitment target of 1–2 participants per month. The median number of face to face therapy sessions received was 6 [IQR 3–8]. The median number of daily repetitions of activities recorded was 80 [IQR 39–80]. Data about usual post stroke rehabilitation were available for 18/24 (75 %). Outcome data were available for 22/24 (92 %) at one month and 20/24 (83 %) at three months. Outcome assessors were unblinded to participant group allocation for 11/22 (50 %) at one month and 6/20 (30 %) at three months. Four adverse events were considered serious as they resulted in hospitalisation. None were related to study treatment. Feedback from patients and therapists about the RFTP programme was mainly positive.ConclusionsA multi-centre randomised controlled trial to evaluate an upper limb RFTP therapy programme provided early after stroke is feasible and acceptable to patients and therapists, but there are issues which need to be addressed when designing a Phase III study. A Phase III study will need to monitor and report not only recruitment and attrition but also adherence to the intervention, usual post stroke rehabilitation received, and outcome assessor blinding.Trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) 58527251

Self-directed therapy programmes for arm rehabilitation after stroke: a systematic review

“…In all, 66 of these records were excluded leaving a total of 40 studies (1172 participants) for inclusion. Supplementary Table 1 provides an overview of the studies interventions including 19 randomized controlled/cross-over trials [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] and 21 before and after studies. The amount of time spent in therapy practice across all interventions ranged from 7 to 366 hours 36,40 over a period that ranged from two weeks 21,[36][37][38]42 to five months.…”

“…Two studies used participant-identified goals to assist in the choice of tasks to practice. 12,26 Adherence to programmes was high with the total amount of therapy practice ranging from 26 to 56 hours, of which 67% to 93% was self-directed across a time period ranging between 2 and 10 weeks.…”

“…A total of 16 randomized studies were included in the analyses. [11][12][13][14][17][18][19][20][21][22][23][24][25][26][27][28] Two studies were excluded due to insufficient methodological rigour or poor reporting quality 15,16 and a third did not report on clinical outcomes. 29 None of the studies made a direct comparison between an intervention that was self-directed with the same intervention delivered under supervision of a therapist and all except three studies used a dose-matched control intervention.…”

Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial

“…The robot-assisted training programme integrated training with all three modules of the MIT-Manus robotic gym (shoulder–elbow module, wrist module, hand module integrated on to the shoulder–elbow module). The EULT programme was designed to reflect best practice using repetitive functional task practice to work towards participant-centred goals 10, 11. Therapists recorded data on the content of EULT sessions; the MIT-Manus robotic gym recorded data on the robot-assisted training sessions content.…”

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

“…The robot software records data on the robot protocol used, duration of the sessions and the number of repetitions of upper limb movements undertaken.Staff delivering the robot-assisted training programme receive specific trainingThe enhanced upper limb therapy programme consists of repetitive functional task practice aimed at patient-centred goals. It has been developed from upper limb therapy programmes used in the Botulinum Toxin for the Upper Limb after Stroke (BoTULS) trial [27–29] and the Repetitive Arm Functional Tasks after Stroke (RAFTAS) project [30]. Study-specific manuals describing enhanced upper limb therapy were produced and are used by staff delivering therapy.…”