Short-term Effect of Using Non-immersive Gamified Exercises on Chronic Pain in People With Stroke.

Official title

Measuring Biomarkers for Health in Community Environments: eMBraCE Activity Program; Short Term Effect of Using Non-immersive Gamified Exercises on Chronic Shoulder Pain in People With Chronic Stroke.

Overview

Rehabilitation after stroke is essential to minimize permanent disability. Gamification of exercises has emerged as a promising strategy for increasing motivation and rehabilitation efficacy in people with stroke. However, there is a gap in understanding how exercise gamification can aid in pain management among people with stroke who are experiencing shoulder pain difficulties. This study aims to evaluate the short-term effect of using gamified non-immersive exercises on shoulder pain level, upper limb range of motion, and shoulder and elbow muscle activities while doing different activities in people with chronic stroke. The study will be conducted using an observational study design. Various lab assessments include measuring the ROM of the shoulder (MOCAP), EMG, FNIRS, pain intensity using VAS scale, and muscles activities patterns across upper limb joints.

Interventions

• Other Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES
  The game phase lasts for 2 minutes. These targets are challenging for the participant.
• Other video-based exercises
  The participant will exercise by replicating the exercises demonstrated in a 2-minute video, recorded with the same movement patterns that they will find in the gamified intervention.

Primary outcome measures

• Pain level [Time frame: Pain levels will be measured on the same day, immediately before and immediately after the intervention.]
• Range Of Motion [Time frame: ROM will be measured immediately before starting the interventions]
• Brain Activity using fNIRS (Functional near-infrared spectroscopy) [Time frame: Brain acticities will be measured when participants are asked to do the interventions. It means the time frame will be same as duration of the interventions, approximately 20 minutes.]
• Muscle activity using EMG (Electromyography) [Time frame: Muscle activities will be measured when participants are asked to do the interventions and assessemnts. It means the time frame will be same as duration of the interventions and assessemnts, approximately one and half hours.]

Eligibility criteria

Inclusion criteria

• Experiencing motor difficulties in using the paretic arm, with some use of hand/arm as determined by therapist
• Not participating any other intervention studies
• Male/female ≥18 years old
• Had a stroke requiring with any degree of arm mobility.
• Capacity to consent to participate
• Able to communicate adequately in English with the research team
• Mild or moderate pain in shoulder or upper limb (below 6 and more than 2on the VAS scale).
• Able to walk without any assistant at least for ten meters

Exclusion criteria

• Any medical condition compromising the safety or the ability to take part to the study as determined by the therapist (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
• History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
• Unable to follow two stage command
• Moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by rehab team
• Severe spasticity (more than 2 on the modified Ashworth scale)
• Any device preventing use of EMG, FNIRS i.e. DBS or pacemaker

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United Kingdom · 1 center

• Vsimulator — Exeter

Identifiers

NCT: NCT06863649 · 22-05-04-B-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗