Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial

Abstract Background Prior studies have established that senses of the limb position in space (proprioception and kinaesthesia) are important for motor control and learning. Although nearly one-half of stroke patients have impairment in the ability to sense their movements, somatosensory retraining focusing on proprioception and kinaesthesia is often overlooked. Interventions that simultaneously target motor and somatosensory components are thought to be useful for relearning somatosensory functions while increasing mobility of the affected limb. For over a decade, robotic technology has been incorporated in stroke rehabilitation for more controlled therapy intensity, duration, and frequency. This pilot randomised controlled trial introduces a compact robotic-based upper-limb reaching task that retrains proprioception and kinaesthesia concurrently. Methods Thirty first-ever chronic stroke survivors (> 6-month post-stroke) will be randomly assigned to either a treatment or a control group. Over a 5-week period, the treatment group will receive 15 training sessions for about an hour per session. Robot-generated haptic guidance will be provided along the movement path as somatosensory cues while moving. Audio-visual feedback will appear following every successful movement as a reward. For the same duration, the control group will complete similar robotic training but without the vision occluded and robot-generated cues. Baseline, post-day 1, and post-day 30 assessments will be performed, where the last two sessions will be conducted after the last training session. Robotic-based performance indices and clinical assessments of upper limb functions after stroke will be used to acquire primary and secondary outcome measures respectively. This work will provide insights into the feasibility of such robot-assisted training clinically. Discussion The current work presents a study protocol to retrain upper-limb somatosensory and motor functions using robot-based rehabilitation for community-dwelling stroke survivors. The training promotes active use of the affected arm while at the same time enhances somatosensory input through augmented feedback. The outcomes of this study will provide preliminary data and help inform the clinicians on the feasibility and practicality of the proposed exercise. Trial registration ClinicalTrials.gov NCT04490655. Registered 29 July 2020.

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Acceptability and clinical trial feasibility evaluation of auditory rhythmical cueing to improve gait and physical activity in community dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial

10.21203/rs.2.11717/v2 ◽

2019 ◽

Author(s):

Sarah Moore ◽

Patricia McCue ◽

Silvia Del Din ◽

Heather Hunter ◽

Sue Lord ◽

...

Keyword(s):

Physical Activity ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Community Setting ◽

Community Dwelling ◽

Feasibility Trial ◽

Stroke Survivors ◽

North East ◽

Randomised Controlled

Abstract Background Mobility problems are present in 70-80% of stroke survivors, and can result in impaired gait and reduced physical activity limiting independent living. Auditory rhythmic cueing (ARC) has been used to provide auditory feedback and shows promise in improving a variety of walking parameters following stroke. The aim of this pilot study is to assess the feasibility of conducting a multi-centre, observer blind, randomised controlled trial of auditory rhythmical cueing (ARC) intervention in home and community settings in North East England. Methods This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England. Participants will be within 24 months of stroke onset causing new problems with mobility. Each participant will be randomised to the study intervention or control group. Intervention treatment participants will undertake 18 auditory rhythmical cueing (ARC) treatment sessions over six weeks (3 x 30 minutes per week, 6 supervised (physiotherapist/research associate)/ 12 self-managed) in a home/community setting. A metronome will be used to provide ARC during a series of balance and gait exercises, which will be gradually progressed. The control treatment participants will undertake the same duration balance and gait exercise training programme as the intervention group but without the ARC. Feasibility will be determined in terms of recruitment, retention, adverse events, adherence, collection of descriptive clinical and accelerometer motor performance data at baseline, six weeks and ten weeks and description of participant, provider and clinical therapists’ experiences. As well as using questionnaires to collate participant views, qualitative interviews will be undertaken to further understand how the intervention is delivered in practice in a community setting and to identify aspects perceived important by participants. Discussion The ACTIVATE study will address an important gap in the evidence base by reporting whether it is feasible to deliver auditory rhythmical cueing in the home and community to improve gait and balance parameters following stroke. The feasibility of the study protocol will be established and results will inform the design of a future multi-centre randomised controlled trial. Trial Registration: Trial register: ISRCTN, Trial identifier: ISRCTN10874601: Date of registration: 12/03/2018, URL http://www.isrctn.com/search?q=ISRCTN10874601

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Acceptability and clinical trial feasibility evaluation of auditory rhythmical cueing to improve gait and physical activity in community dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial

10.21203/rs.2.11717/v1 ◽

2019 ◽

Author(s):

Sarah Moore ◽

Patricia McCue ◽

Silvia Del Din ◽

Heather Hunter ◽

Sue Lord ◽

...

Keyword(s):

Physical Activity ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Community Setting ◽

Community Dwelling ◽

Feasibility Trial ◽

Stroke Survivors ◽

North East ◽

Randomised Controlled

Abstract Background Mobility problems are present in 70-80% of stroke survivors, and can result in impaired gait and reduced physical activity limiting independent living. Auditory rhythmic cueing (ARC) has been used to provide auditory feedback and shows promise in improving a variety of walking parameters following stroke. The aim of this pilot study is to assess the feasibility of conducting a multi-centre, observer blind, randomised controlled trial of auditory rhythmical cueing (ARC) intervention in home and community settings in North East England. Methods This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England. Participants will be within 24 months of stroke onset causing new problems with mobility. Each participant will be randomised to the study intervention or control group. Intervention treatment participants will undertake 18 auditory rhythmical cueing (ARC) treatment sessions over six weeks (3 x 30 minutes per week, 6 supervised (physiotherapist/research associate)/ 12 self-managed) in a home/community setting. A metronome will be used to provide ARC during a series of balance and gait exercises, which will be gradually progressed. The control treatment participants will undertake the same duration balance and gait exercise training programme as the intervention group but without the ARC. Feasibility will be determined in terms of recruitment, retention, adverse events, adherence, collection of descriptive clinical and accelerometer motor performance data at baseline, six weeks and ten weeks and description of participant, provider and clinical therapists’ experiences. As well as using questionnaires to collate participant views, qualitative interviews will be undertaken to further understand how the intervention is delivered in practice in a community setting and to identify aspects perceived important by participants. Discussion The ACTIVATE study will address an important gap in the evidence base by reporting whether it is feasible to deliver auditory rhythmical cueing in the home and community to improve gait and balance parameters following stroke. The feasibility of the study protocol will be established and results will inform the design of a future multi-centre randomised controlled trial. Trial Registration: Trial register: ISRCTN, Trial identifier: ISRCTN10874601: Date of registration: 12/03/2018, URL http://www.isrctn.com/search?q=ISRCTN10874601

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