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The Neurological and Clinical Effects of Game Therapy in Fibromyalgia Patients

Neurophysiological and clinical effects promoted by Game Therapy in Fibromyalgia: Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8jdbrm
Enrollment
Unknown
Registered
2019-04-01
Start date
2019-02-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

Intervention Procedures The 20 participants in the game therapy group will use the Nintendo Wii (R) as a therapeutic tool, which in turn will be composed of control devices (Wii Remote) and the Wii B
Other
L01.224.160.875
G11.427.410.698.277

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Universidade Federal de Sergipe
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria for the study will consist of clinical diagnosis of Fibromyalgia; female gender; autonomy to perform the exercises; preserved cognitive aspect evaluated through the Mini Mental Status Examination.

Exclusion criteria

Exclusion criteria: Patients who present with uncorrected visual deficit; associated neurological or psychiatric disease; orthopedic or cardiac limiting changes; lose 3 consecutive sessions of the intervention protocol; and changes in medication during the study will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: That the game therapy is more effective than conventional physical exercises to reduce pain intensity, as well as increase the threshold of pressure pain and cutaneous sensory threshold. It is believed that not performing any type of physical exercise can worsen or stagnate the pain of these patients. Evaluation method: Intensity of pain at rest and in movement (Numerical Scale of 11 points), pressure pain threshold (digital algometry), cutaneous sensory threshold (Von Frey filaments), temporal summation (Temporal Summation Test), conditioned modulation of pain (Conditional Modulation of Pain Test). ;Expected outcome 2: It is believed that game therapy is more effective than conventional physical exercises to improve electrical, neurobiological, concentration and attention aspects. And, fibromyalgia that do not perform physical exercise can worsen or stagnate your pain. Evaluation method: encephalic electrical activity (EEG), concentration and attention (P300 evoked endogenous potential)

Secondary

MeasureTime frame
Expected outcome 1: That game therapy is more effective than conventional physical exercises to improve functional capacity and trunk muscle strength. Evaluation method: Rikli Jones battery and trunk dynamometer.;Expected outcome 3: That the game therapy may promote the increase of the concentration of anti-inflammatory cytokines and decrease the pro-inflammatory ones. As well as it can promote decrease of the hormone cortisol. Evaluation method: ELISA enzymatic tests, using commercial kit (eBioscience).;Expected outcome 2: Increase motivation, compliance, quality of life and sleep, as well as decrease depression and physical disability of patients with fibromyalgia. Evaluation Method: The Motivation Inventory for Exercise (IME-2), the quality of life evaluation will be performed using the Short Form Health Survey 36 (SF-36), the Pittsburgh Sleep Quality Index (PSQI), Roland Morris Physical Impairment Questionnaire (QIRM) and Beck Depression Inventory.

Countries

Brazil

Contacts

Public ContactAkeline;Josimari Almeida;Santana

Universidade Federal de Sergipe;Universidade Federal de Sergipe

akelinefisioterapeuta@Gmail.com;josimelo@infonet.com.br+55-79-9863-5760;+55 79 3281-2939

Outcome results

None listed

Source: REBEC (via WHO ICTRP)