Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity

NCT ID: NCT05787119

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2025-09-30

Brief Summary

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Complex Regional Pain Syndrome (CRPS) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". The diagnostic criteria of the disease follow the Budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair).

Of the many treatments, augmented reality mirror therapy (ARMT), is novel in substituting a virtual environment for part of the real environment. This type of device has never been studied from a clinical point of view in the treatment of upper limb CRPS, whereas fMRI and clinical dissertation studies have suggested an improvement in neuroplasticity.

The aim of this study is to establish the clinical effects of ARMT on CRPS, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).

Detailed Description

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Conditions

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Complex Regional Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy

Group Type EXPERIMENTAL

Conventional therapy

Intervention Type OTHER

The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.

ARMT

Intervention Type OTHER

The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.

cortical reactivity

Intervention Type OTHER

An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).

Fluidity of movement

Intervention Type OTHER

Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).

Group 2

3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy

Group Type EXPERIMENTAL

Conventional therapy

Intervention Type OTHER

The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.

ARMT

Intervention Type OTHER

The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.

cortical reactivity

Intervention Type OTHER

An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).

Fluidity of movement

Intervention Type OTHER

Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).

Group 3

2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy

Group Type EXPERIMENTAL

Conventional therapy

Intervention Type OTHER

The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.

ARMT

Intervention Type OTHER

The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.

cortical reactivity

Intervention Type OTHER

An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).

Fluidity of movement

Intervention Type OTHER

Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).

Interventions

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Conventional therapy

The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.

Intervention Type OTHER

ARMT

The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.

Intervention Type OTHER

cortical reactivity

An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).

Intervention Type OTHER

Fluidity of movement

Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient with CRPS of the upper limb according to the Budapest criteria.
* Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes.
* Patient with a diagnosis of CRPS for more than 3 months

Exclusion Criteria

* The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study
* The subject unable to express consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
* Patient with medically significant visual impairment that is incompatible with the practice of ARMT
* Patient with CRPS secondary to a stroke
* Patient with cognitive disorders (Montreal Cognitive Assessment scale less than 26)
* Patient with Unilateral Spatial Negligence according to the Bell's test
* Patient with arthrodesis of one of the joints of the upper limbs.
* Patient with an unhealed fracture of one of the upper limbs
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud DUPEYRON

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

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CHU de Nîmes

Nîmes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Arnaud DUPEYRON

Role: CONTACT

04.66.68.34.59

Facility Contacts

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Anissa Megzari, Pr

Role: primary

04.66.68.42.36

Arnaud Dupeyron

Role: backup

Gabriel COHEN-AKNINE

Role: backup

Other Identifiers

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NIMAO/2022-AD-01

Identifier Type: -

Identifier Source: org_study_id

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