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NCT Number: NCT06863649

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

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.

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Key information

Conditions

Stroke Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES

Other

The game phase lasts for 2 minutes. These targets are challenging for the participant.

video-based exercises

Other

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 outcomes

  1. Pain level

    Time frame: Pain levels will be measured on the same day, immediately before and immediately after the intervention.

    Pain levels will be measured using VAS (visual analog scale).

  2. Range Of Motion

    Time frame: ROM will be measured immediately before starting the interventions

    This will be measured by doing Arm Abduction, Arm Flexion, Hand to Mouth, and Hand to Head. They will be measured by using a specific questionnaire of how well the participant can do each of them.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatem Lazem

CONTACT

[email protected]

+447436959585

Shaghayegh Nayebi

CONTACT

[email protected]

+447508489796

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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