NCT05253989

Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation

Status unknown NA Last updated 25 April 2022

What this trial tests

NA trial testing VR Intervention in Stroke in 98 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
31 March 2024

30 October 2024

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	1 May 2022
Primary completion	31 March 2024
Estimated completion	30 October 2024

Drugs / interventions tested

• VR Intervention
• FES — full drug profile →

Conditions studied

• Stroke — all drugs for Stroke →
• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Stroke or Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Novel approaches are needed for the management of stroke patients, as current practice relies on the presence of a qualified professional, of which there are severe shortages. Rehabilitation technologies provide a unique solution to this problem. Recent technological advances in EMG signal processing mean that researchers are now able to decompose EMG recordings of the residual muscle activity of stroke survivors. This information can be used to detect biomarkers of a patient's functional status, allowing an objective measure of function to be obtained. This information could be used to predict patient recovery and decide on the best course of treatment. Furthermore, this technology can be used to predict attempted patient movements, which could be used to drive a virtual reality interface that gives feedback on movement attempts. This could be delivered through a gaming interface, creating an enjoyable and motivational rehabilitation technology for stroke patients, and providing a treatment option for the most severe patients. Synchronizing patients' attempted movements with electrical stimulation of the desired muscle groups may further enhance neuroplasticity and rehabilitation outcomes. Advances in electronics have made it so electrical stimulation systems are wearable, portable and comfortable, commonplace in rehabilitation clinics and accessible to the general public (https://www.surge.co.uk/).

In order to verify the clinical validity of such an approach, there is a need to conduct a large scale trial (6 months). The purpose of this study will be to assess the clinical validity of a gaming-based intervention driven by EMG activity in promoting long-term functional recovery. The study will also be assessing the capability of an AI algorithm to predict long-term recovery based on biomarkers detected in the early EMG signals. The team wishes to conduct a large scale trial to learn from the past mistakes of rehabilitation technologies, which were insufficiently powered to result in statistically significant outcomes, especially given the heterogeneous nature of the stroke population.

The impact of such an intervention could be revolutionary for stroke patients. It would provide a treatment option for severe stroke patients, where none currently exists. It also ensures that rehabilitation could be commenced within the most time-critical period (the earliest weeks following stroke). Such an intervention would integrate easily into existing care practice and relieve some of the pressure on the NHS. The long-term impact would be to significantly improve the lives of stroke survivors and substantially reduce the burden on the NHS.

Furthermore, the implications of this technology would go beyond stroke rehabilitation, and could be used in any patient with any form of paralysis. In order to test and validate this, the study team are also looking to include a small proportion of spinal cord injury patients in the protocol. The rationale being two-fold: they provide an alternative recruitment pool, with a simpler injury that does not also cause cognitive impairments, meaning they will be easier to collect data from and draw meaningful conclusions, in addition, it will help support that this technology can be useful in different patient groups and provide insight for future research directions. Spinal cord injury was chosen as a second condition, as like stroke it is one of the largest causes of paralysis, but tends to affect a younger patient population, which will allow us to compare the efficacy of this treatment approach in different age groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.