Clinical trial NCT06863649: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke Patients
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include 30 individuals of both genders experiencing shoulder pain. The inclusion criteria require participants to be over the age of 18, experiencing motor difficulties, have a stroke requiring upper/limb mobility rehabilitation, and be able to consent and communicate. Participants should not have other medical conditions that compromise the safety or ability to take part in the study.

Brief summary: 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.


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

Primary outcomes:
measure: Pain level
timeFrame: Pain levels will be measured on the same day, immediately before and immediately after the intervention.
measure: Range Of Motion
timeFrame: ROM will be measured immediately before starting the interventions
measure: Brain Activity using fNIRS (Functional near-infrared spectroscopy)
timeFrame: 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.
measure: Muscle activity using EMG (Electromyography)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Vsimulator
state: Devon
Study officials:
affiliation: University of Exeter
name: Helen Dawes
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Exeter
name: Maedeh Mansoubi, PhD
role: PRINCIPAL_INVESTIGATOR
References: