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

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb
• Intervention / Treatment: Device: H'ability

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline ALi, Doctor; Phone Number: 33678874242; Email: pauline.ali@chu-angers.fr
• Study Contact Backup: Name: Viviane CASSISA; Phone Number: 33241356831; Email: vicassisa@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers
    • Contact: Pauline ALI, Doctor; Email: pauline.ali@chu-angers.fr
    • Principal Investigator: Pauline ALI, Dr
  • Laval, France, 53000
    • Recruiting
    • CH LAVAL
    • Contact: Romain Champagne Doctor Champagne Romain; Email: Romain.CHAMPAGNE@chlaval.fr
    • Sub-Investigator: Romain Champagne Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Upper limb surgery < 6 months
• Infection or pathology of the central nervous system or active cancer
• Fibromyalgia
• Severe psychiatric or cognitive disorders
• Diabetes mellitus complicated by peripheral neuropathy
• Neurogenic paraosteoarthropathy or recent fracture
• Pregnancy or breast-feeding.
• Poor understanding of the French language.
• Person deprived of liberty by judicial or administrative decision
• Psychiatric disorder
• Person subject to a legal protection measure
• Person unable to give consent
• In connection with the virtual reality device: unstabilized epilepsy, facial trauma < 3 months, hearing or visual impairment, pain, dizziness or nausea caused by the use of virtual reality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: H'ability; H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist
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.	Device: H'ability; H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist
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.	Device: H'ability; H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist
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.	Device: H'ability; H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire	The self-questionnaire contains 11 items to assess the patient's ability to perform certain activities of daily living, the severity of the pain, the impact of the condition on social or professional life, etc. rated on a scale of 1 (no difficulty or inability) to 5 (unable to do)	5 times per week for 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-assessment of pain using the Numerical Scale (EN)	numerical scale from 1 to 10	5 times per week for 7 weeks
subjective assessment of pain via the PSEQ-2 self-questionnaire	PSEQ-2 (Pain Self Efficacy Questionnaire). measure patients' confidence in their ability to perform tasks despite pain-scale from 0 to 6.	5 times per week for 7 weeks
functional assessment of the shoulder using the C-test	measurement of the thoracohumeral angle during active elbow elevation	5 times per week for 7 weeks
self-evaluation of performance and feeling of satisfaction associated with the difficulties identified by the patient with MCRO questionnaire	Mesure Canadienne du Rendement Occupationnel (MCRO). Scale from 1 to 10	One time between day 7 and day 14 + one time between week 6 and week 7.
Measure of Constant score:composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.	composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.	One time between day 7 and day 14 + one time between week 6 and week 7.
assessment of kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)	reliable and validated self-questionnaire in French which assesses through 17 items the fear of movement in connection with the fear of being injured during a movement (25). Each question is scored between 1 (strongly disagree) and 4 (strongly agree) with the exception of items 4, 8, 12 and 16 which are inversely scored with 1 (strongly agree ) and 4 (strongly disagree). A total score greater than or equal to 40 confirms significant kinesiophobia and the higher the score, the greater the kinesiophobia.	once at inclusion + one time between week 6 and week 7.
assessing grip strength with the Jamar test	This is a quick and simple test that requires squeezing a hydraulic dynanometer to its fullest extent. 3 repeated measurements are taken on one side then the other and only the highest value is retained for each side. It has been shown in the literature that grip strength is a good indicator of overall upper limb strength and that muscle strength in a chronically painful limb is reduced.	One time between day 7 and day 14 + one time between week 6 and week 7.
assessing dexterity with the Box and Block Test (BBT)	It consists of 150 cubes placed in a wooden box with two equal-sized compartments. The patient must move, with one hand, a maximum of cubes from one compartment to another, one by one, in 1 minute. The score obtained corresponds to the number of cubes moved for each hand in one minute.	One time between day 7 and day 14 + one time between week 6 and week 7.
assessing dexterity with the Purdue Pegboard Test (PPT)	The test involves taking small metal pegs and placing them in the small holes of a standardized board for 30 seconds	One time between day 7 and day 14 + one time between week 6 and week 7.
self-assessment of the H'ability© device according to healthcare professionals and patients using the SUS scale (System Usability Scale)	questionnaire for measuring the usability of interactive systems, validated in French, which includes 10 items associated with a 5-point Likert scale (from 1 = Completely disagree to 5 = Completely agree). The overall score is obtained by subtracting 1 from the score checked for items 1, 3, 5, 7 and 9, then calculating 5 minus the score checked for items 2, 4, 6, 8 and 10 (items whose wording is negative and reverse rating). The 10 scores thus calculated are added and multiplied by 2.5, to obtain a total score between 0 and 100 (a higher score means better usability).	one time between week 6 anD week 7.

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): July 4, 2026
• Study Completion (Estimated): September 4, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: 49RC24_0066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No