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

NCT06863649 | Recruiting

• 1 other identifier: 22-05-04-B-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Patients

Outcome Measures

Primary Outcomes (4)

• Pain level

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

  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.

  ROM will be measured immediately before starting the interventions

• Brain Activity using fNIRS (Functional near-infrared spectroscopy)

  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)

  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 Arms (1)

chronic people with stroke

Other: Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES; Other: video-based exercises

Interventions

Gamified NON-IMMERSIVE VIRTUAL REALITY EXERCISES OTHER

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

chronic people with stroke

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.

chronic people with stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

Vsimulator

Exeter, Devon, EX52GD, United Kingdom

RECRUITING

Study Officials

• Helen Dawes

  University of Exeter

  PRINCIPAL INVESTIGATOR

• Maedeh Mansoubi, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaghayegh Nayebi

CONTACT

+447508489796; sn506@exeter.ac.uk

Hatem Lazem

CONTACT

+447436959585; hl756@exeter.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)