An interventional study of H'ability in Complex Regional Pain Syndrome Type I of the Upper Limb, sponsored by University Hospital, Angers. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Treatment
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.
43 studies on the registry are indexed under Reflex Sympathetic Dystrophy; 4 are open to participants now.
This study's enrollment of 13 is below the median of 48 across 35 interventional studies indexed under Reflex Sympathetic Dystrophy.
Browse Reflex Sympathetic Dystrophy studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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)
Time frame: 5 times per week for 7 weeks
self-assessment of pain using the Numerical Scale (EN)
numerical scale from 1 to 10
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: one time between week 6 anD week 7.
Ran from Nov 2024 to primary completion in Apr 2026, 17 months.
Of 15 interventional studies with no phase under Reflex Sympathetic Dystrophy, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 17 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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