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Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Chronic pain represents a significant public health concern, given its high prevalence and the substantial impact it has on the quality of life of many individuals affected. There is no single, universally effective medical treatment for chronic pain. The gold standard for treatment is a multidisciplinary rehabilitation program. Immersive virtual reality (IVR) represents a novel and promising approach to do rehabilitation, offering the potential to enhance engagement and perception of movement. The objective of this study was to investigate the improvement of upper limb function in chronic pain patients using an IVR device in occupational therapy sessions during a rehabilitation program.

Methods: The study use a single-case experimental design (SCED) to investigate the efficacy of IVR device in improving upper limb function in patients with upper limb chronic pain. The study was conducted in three phases: baseline, intervention, and follow-up. The SCED will be with multiple baseline across subjects, whereby the patient serves as his own control. A total of 12 participants will be included. The virtual reality sessions will be conducted exclusively during the intervention phase. The primary outcome measure will be the upper limb function, as assessed by the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. Furthermore, the intensity of pain will be quantified using a numeric scale, and the pain self-efficacy will be evaluated using the Pain Self-Effacity Short Form Questionnaire. Expected results: This method will allow for the comparison of phases within and between subjects to determine whether the IVR sessions improve the function assessed by the Quick DASH.

Conclusion: Further investigation is required to determine the potential benefits of using IVR for upper limb chronic pain rehabilitation, with a particular focus on the development of precise protocols for its use in clinical settings.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Chronic pain in the upper limb, predominantly in one or both upper limbs, for more than 3 months

• Age between 18 and 65

• Patient affiliated with or benefiting from a social security organization

• Person able to tolerate the virtual reality device

• Informed consent form signed

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CH LAVAL
RECRUITING
Laval
Contact Information
Primary
Pauline ALi, Doctor
pauline.ali@chu-angers.fr
33678874242
Backup
Viviane CASSISA
vicassisa@chu-angers.fr
33241356831
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2026-09-04
Participants
Target number of participants: 12
Treatments
Other: introduction of the intervention phase before session 4 with occupational therapist
The first group will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.
Other: introduction of the intervention phase before session 5 with occupational therapist
The second group will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.
Other: introduction of the intervention phase before session 6 with occupational therapist
The third group will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.
Other: introduction of the intervention phase before session 7 with occupational therapist
The fourth group will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov