Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial

Objective To investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke.Design A feasibility randomised controlled trial with a parallel process evaluation.Setting Acute Stroke Unit and participants’ homes (London, UK)....

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Main Authors: Cherry Kilbride, Tom Butcher, Meriel Norris, Nana Anokye, Alyson Warland, Karen Baker, Dimitrios A Athanasiou, Guillem Singla-Buxarrais, Jennifer Ryan, Francesca Gowing, Elmar Kal, Carole Pound, Victoria Stewart, Basaam Aweid, Arul Samiyappan
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Language:English
Published: BMJ Publishing Group 2025-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/1/e089672.full
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author Cherry Kilbride
Tom Butcher
Meriel Norris
Nana Anokye
Alyson Warland
Karen Baker
Dimitrios A Athanasiou
Guillem Singla-Buxarrais
Jennifer Ryan
Francesca Gowing
Elmar Kal
Carole Pound
Victoria Stewart
Basaam Aweid
Arul Samiyappan
author_facet Cherry Kilbride
Tom Butcher
Meriel Norris
Nana Anokye
Alyson Warland
Karen Baker
Dimitrios A Athanasiou
Guillem Singla-Buxarrais
Jennifer Ryan
Francesca Gowing
Elmar Kal
Carole Pound
Victoria Stewart
Basaam Aweid
Arul Samiyappan
author_sort Cherry Kilbride
collection DOAJ
description Objective To investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke.Design A feasibility randomised controlled trial with a parallel process evaluation.Setting Acute Stroke Unit and participants’ homes (London, UK).Participants 24 adults (>18 years), acute and subacute poststroke, new unilateral weakness, scoring 9–25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate.Interventions Participants randomised to the intervention or control group on a 2:1 ratio. The intervention group (n=16) received usual care plus the Neurofenix platform for 7 weeks. The control group (n=8) received usual care only.Outcomes Safety was assessed through adverse events (AEs), pain, spasticity and fatigue. Feasibility was assessed through training and support requirements and intervention fidelity. Acceptability was assessed through a satisfaction questionnaire. Impairment, activity and participation outcomes were also collected at baseline and 7 weeks to assess their suitability for use in a definitive trial.Randomisation Computer-generated, allocation sequence concealed by opaque, sealed envelopes.Blinding Participants and assessors were not blinded; statistician blinded for data processing and analysis.Results 192 stroke survivors were screened for eligibility, and 24 were recruited and randomised. Intervention group: n=16, mean age 66.5 years; median 9.5 days post stroke. Control group: n=8, mean age 64.6 years; median 17.5 days post stroke. Three participants withdrew before the 7-week assessment, n=21 included in the analysis (intervention group n=15; control group n=6). No significant group differences in fatigue, spasticity, pain scores or total number of AEs. The median (IQR) time to train participants was 98 (64) min over 1–3 sessions. Participants trained with the platform for a median (range) of 11 (1-58) hours, equating to 94 min extra per week. The mean satisfaction score was 34.9 out of 40.Conclusion The Neurofenix platform is safe, feasible and well accepted as an adjunct to usual care in acute and subacute stroke rehabilitation. There was a wide range of engagement with the platform in a cohort of stroke survivors which was varied in age and level of impairment. Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible.Trial registration number ISRCTN11440079.
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spelling doaj-art-e9d72c22677c4c1e9b8cc29a38ec0b0a2025-02-08T20:15:10ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-089672Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trialCherry Kilbride0Tom Butcher1Meriel Norris2Nana Anokye3Alyson Warland4Karen Baker5Dimitrios A Athanasiou6Guillem Singla-Buxarrais7Jennifer Ryan8Francesca Gowing9Elmar Kal10Carole Pound11Victoria Stewart12Basaam Aweid13Arul Samiyappan14Department of Health Sciences, Brunel University of London, Uxbridge, UKDepartment of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, UKDepartment of Health Sciences, Brunel University of London, Uxbridge, UKDepartment of Health Sciences, Brunel University of London, Uxbridge, UKDepartment of Health Sciences, Brunel University of London, Uxbridge, UKNeurofenix, London, UKNeurofenix, London, UKNeurofenix, Atlanta, Georgia, USASchool of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, IrelandDepartment of Health Sciences, Brunel University of London, Uxbridge, UKDepartment of Health Sciences, Brunel University of London, Uxbridge, UKIndependent Researcher, London, UKDepartment of Health Sciences, Brunel University of London, Uxbridge, UKHillingdon Hospitals NHS Foundation Trust, Uxbridge, UKCentral and North West London NHS Foundation Trust, London, UKObjective To investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke.Design A feasibility randomised controlled trial with a parallel process evaluation.Setting Acute Stroke Unit and participants’ homes (London, UK).Participants 24 adults (>18 years), acute and subacute poststroke, new unilateral weakness, scoring 9–25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate.Interventions Participants randomised to the intervention or control group on a 2:1 ratio. The intervention group (n=16) received usual care plus the Neurofenix platform for 7 weeks. The control group (n=8) received usual care only.Outcomes Safety was assessed through adverse events (AEs), pain, spasticity and fatigue. Feasibility was assessed through training and support requirements and intervention fidelity. Acceptability was assessed through a satisfaction questionnaire. Impairment, activity and participation outcomes were also collected at baseline and 7 weeks to assess their suitability for use in a definitive trial.Randomisation Computer-generated, allocation sequence concealed by opaque, sealed envelopes.Blinding Participants and assessors were not blinded; statistician blinded for data processing and analysis.Results 192 stroke survivors were screened for eligibility, and 24 were recruited and randomised. Intervention group: n=16, mean age 66.5 years; median 9.5 days post stroke. Control group: n=8, mean age 64.6 years; median 17.5 days post stroke. Three participants withdrew before the 7-week assessment, n=21 included in the analysis (intervention group n=15; control group n=6). No significant group differences in fatigue, spasticity, pain scores or total number of AEs. The median (IQR) time to train participants was 98 (64) min over 1–3 sessions. Participants trained with the platform for a median (range) of 11 (1-58) hours, equating to 94 min extra per week. The mean satisfaction score was 34.9 out of 40.Conclusion The Neurofenix platform is safe, feasible and well accepted as an adjunct to usual care in acute and subacute stroke rehabilitation. There was a wide range of engagement with the platform in a cohort of stroke survivors which was varied in age and level of impairment. Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible.Trial registration number ISRCTN11440079.https://bmjopen.bmj.com/content/15/1/e089672.full
spellingShingle Cherry Kilbride
Tom Butcher
Meriel Norris
Nana Anokye
Alyson Warland
Karen Baker
Dimitrios A Athanasiou
Guillem Singla-Buxarrais
Jennifer Ryan
Francesca Gowing
Elmar Kal
Carole Pound
Victoria Stewart
Basaam Aweid
Arul Samiyappan
Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
BMJ Open
title Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
title_full Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
title_fullStr Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
title_full_unstemmed Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
title_short Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
title_sort rehabilitation using virtual gaming for hospital and home based training for the upper limb in acute and subacute stroke rhombus ii results of a feasibility randomised controlled trial
url https://bmjopen.bmj.com/content/15/1/e089672.full
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