Stroke PatientsNCT06863649
Short-term Effect of Using Non-immersive Gamified Exercises on Chronic Pain in People With Stroke.
An observational study of Stroke Patients, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES and video-based exercises
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2025to Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Vsimulator
Exeter, Devon, EX52GD
Shaghayegh Nayebi, +447508489796, sn506@exeter.ac.uk
Hatem Lazem, +447436959585, hl756@exeter.ac.uk
About this study
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.
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.
- Conditions
- Stroke Patients
- Being tested
- Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES, video-based exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISESOther
The game phase lasts for 2 minutes. These targets are challenging for the participant.
video-based exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic people with stroke | Not described Receives: Other: Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES; Other: video-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain levels will be measured using VAS (visual analog scale).
Measured: Pain levels will be measured on the same day, immediately before and immediately after the intervention.
Range Of Motion
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.
Measured: ROM will be measured immediately before starting the interventions
Brain Activity using fNIRS (Functional near-infrared spectroscopy)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Mar 2025
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Dawes, Principal investigator, University of ExeterMaedeh Mansoubi, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863649
- Sponsor's protocol ID
- 22-05-04-B-02
- Status last verified
- Apr 2025
- First submitted
- 20 Jan 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06863649
- Acronym / sponsor ID
- 22-05-04-B-02
- Conditions
- Stroke Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic people with stroke | – | Other: Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES, Other: video-based exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISESThe game phase lasts for 2 minutes. These targets are challenging for the participant. | Other | chronic people with stroke |
| video-based exercisesThe 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. | Other | chronic people with stroke |
Primary outcome
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen Dawes principal investigator
University of Exeter
Maedeh Mansoubi, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Patients, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaghayegh Nayebi (+447508489796, sn506@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Pain levels will be measured on the same day, immediately before and immediately after the intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.