Self-directed Adapted Gaming Exercises for stroke survivors: SAGE

• Research type

  Research Study

• Full title

  A multicentre pilot randomised control trial (RCT) of an adapted mobile rehabilitation system (GripAble) for self-directed upper limb (UL) rehabilitation and improved UL outcomes in stroke survivors with UL weakness.

• IRAS ID

  283483

• Contact name

  Paul Bentley

• Contact email

  P.Bentley@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Clinicaltrials.gov Identifier

  NCT04475692

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Research Summary

  Title: A multicentre pilot randomised control trial (RCT) of an adapted mobile rehabilitation system (GripAble) for self-directed upper limb (UL) rehabilitation and improved UL outcomes in stroke survivors with UL weakness.

  Design: Interventional (clinical trial). A multicentre pilot RCT, parallel design, comparing intervention group (self-selected dose of self-directed technology-based UL exercise as an adjunct to conventional care) with a control group receiving conventional care only. A mixed methods research design will be implemented. This will be an assessor-blinded protocol, due to the nature of the intervention, participants cannot be blinded. This will be an internal pilot, if no changes are made to the protocol and additional funding is secured, the data from this pilot work will be used be used as part of an adequately powered RCT.

  Aims: To test research design considerations in preparation for a definitive multicentre RCT. To explore the hypothesis that stroke survivors with UL weakness will engage in self-directed exercise (without direct professional supervision) as an adjunct to conventional care and demonstrate significant improvement in UL outcomes when provided with an adapted mobile rehabilitation system, compared with a control group participating in conventional care only.

  Outcome Measures: The primary end point outcome will be the between group difference on the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6months post randomisation.

  Population: A convenience sample of 72 stroke survivors will be screened and consented by delegated health care practitioners (HCPs) or researchers at participating sites (i.e Co-Investigators. Co-Is will also be invited to complete end-point feedback forms.

  Eligibility: Participants will be 18yrs or over, acute/sub-acute stroke survivors with new UL impairment, fitting inclusion criteria specified herewith.

  Duration: Participants’ enrolment in the study will last up to 6months. The study recruitment phase will open for a total of 12months: The overall research period, including analysis and write up is anticipated to last 21months.
  
  Summary of Results

  Background: Arm weakness is a common problem experienced after stroke. It limits independence and quality of life for stroke survivors. A significant amount of arm rehabilitation is needed to promote of recovery (approximately 2hours daily), however it is challenging for healthcare services to deliver this due in part to competing service demands and limited available resources. New technologies may help to increase the amount of arm rehabilitation stroke survivors complete, by supporting independent (or self-directed) exercise using interactive gaming technologies. Thus far, not enough is known about how safe or effective these technologies are or how stroke survivors feel about using them as part of their rehabilitation.

  Aims: A randomised controlled trial (RCT) is a type of experiment that is considered "gold standard" for testing new treatments. RCTs are designed to be very fair and unbiased. Randomly assigning research participants (by chance) to either an intervention group (where they receive the experimental intervention) or a control group (where they receive a different intervention or no intervention) and concealing from the assessors which group participants are in, helps to ensure that the results are due to the treatment itself and not other factors. Before completing an RCT, researchers must first complete a pilot RCT. This allows them to test their research protocol within a smaller group of participants to check that it is safe, feasible and worthwhile to conduct a large-scale study. This study was a pilot RCT, testing the use of an interactive gaming technology (GripAble) for self-directed arm rehabilitation after stroke.
  Methods: In this study we recruited people early after stroke from 3 hospitals in London and the south-east of England and tracked their recovery up until 6months after their stroke. Participants were randomly assigned to 1 of 2 groups. The intervention group were loaned the interactive gaming technology for independent arm rehabilitation in addition to their usual rehabilitation for the first 3 months after their stroke; the device electronically recorded how much training they completed. Intervention group participants also had access to coaching and technology support to assist them with their training as/when needed. The control group received usual rehabilitation and were not contacted by the research team except for completion of assessments. Both groups were assessed within the first month of stroke, 3months after stroke and 6months after stroke to monitor their recovery. These assessments examined arm movement and ability to perform everyday functional activities. In-depth interviews were also completed with a sample of 10 participants from the intervention group to explore their experiences and feelings about using the technology as part of their rehabilitation.

  Results: 55 stroke survivors were recruited to the research, 40 were still participating at the end-point (6months post stroke). Intervention group participants (28) completed a median of 10 self-directed rehabilitation sessions with the technology (IQR: [3, 18]) over 81 days (IQR: [73, 86]). These sessions each lasted for a median of 12 minutes (IQR: [6, 232]) and consisted of 452 arm exercise repetitions (IQR: [175, 624]). Not all rehabilitation sessions were recorded, as some participants did not login to their unique user profile for training and so data was compromised. Intervention group participants engaged to varying degrees with support offered by the research team (i.e. coaching and technology support); typically engaging in 6 support sessions (IQR: [4, 8]) over the intervention period. Those who engaged in more researcher support sessions completed a greater amount of rehabilitation (P=0.003). The intervention group demonstrated slightly greater improvements in arm movement and functional ability from 0 to 6 months post-stroke (Fugl Meyer-Upper Extremity Assessment (β=2.34, σ=2.77, P=.40), Action Research Arm Test (β=3.57, σ=4.78, P=.46), Barthel Index (β=5.83, σ=6.25, P=.36) and modified Rankin Scale (β=-0.3, σ=0.24, P=.21); results did not reach statistical significance however. Participants who trained >10 in total hours showed greater arm recovery at 6months post-stroke than those who trained less. There were no serious safety concerns recorded in either the intervention or control group during this research. There were no differences in assessments of fatigue or pain between the groups. Participants were generally satisfied with their experience of participating in the research. Approximately 300 participants will be required to test the efficacy of this intervention for arm recovery in a full-scale RCT. Six key themes were generated from interviews with intervention group participants (10). These themes related to 1.) the complexity and competing demands of life after stroke 2.) the impact of the physical and social environment 3.) issues in accessibility and reliability of the technology 4.) the perceived benefits of technology-facilitated training needing to outweigh associated effort or risk 5.) the importance of everyday functional activities and 6.) beliefs about recovery and rehabilitation.

  Conclusion:
  Interactive gaming technologies for independent arm exercise may improve arm recovery after stroke, a larger sample size is needed to fully test this. Our findings highlight the complex experiences of life after stroke and the ways in which these impact upon participation in self-directed rehabilitation activities, the challenges and opportunities presented by technology-facilitated rehabilitation, the importance of social and emotional support (formal or informal) and the drive of stroke survivors exercise autonomy through supported self-management within the context of their rehabilitation. Further work is needed to refine complex intervention design and evaluation (for intervention components such as coaching and technology support), as well as to enhance the accessibility and reliability of the technology to ensure consistent usage behaviour and accurate electronic data collection.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  21/LO/0054

• Date of REC Opinion

  18 Mar 2021

• REC opinion

  Further Information Favourable Opinion