Right/Left Discrimination Training on Fibromyalgia Patients

NCT ID: NCT05915598

Last Updated: 2023-06-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-25

Study Completion Date

2024-08-04

Brief Summary

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To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Right/left discrimination training: The training program will consist of tasks such as identifying the laterality of images (e.g., hands, feet, faces) and sounds (e.g., spatially localized sounds). The tasks will be designed with increasing levels of difficulty to challenge participants and promote skill development.

Training schedule: Participants will be instructed to engage in the right/left discrimination training for 20 minutes per day, 5 days per week, over a six-week period. They will be encouraged to complete the training sessions at consistent times to support habit formation.

Monitoring and feedback: The research team will remotely monitor participants' progress and provide personalized feedback on a weekly basis. This will include reviewing performance metrics within the app, discussing any challenges or barriers to adherence, and offering guidance to support continued engagement in the training program.

Group Type EXPERIMENTAL

Right/left discrimination training

Intervention Type OTHER

Participants will use recognize app by Neuro-orthopedic institute (NOI) for daily right/left discrimination training.

The training will include visual and auditory stimuli, with tasks such as identifying the laterality of images and sounds.

Participants will engage in training for 20 minutes per day, 5 days per week, over a six-week period.

Weekly monitoring and feedback will be provided by the research team

Control group

Usual care: Participants will continue their usual care management for fibromyalgia, including any prescribed medications and physician consultations. No specific right/left discrimination training will be provided to the control group.

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Usual care: Participants will continue their usual care management for fibromyalgia, including any prescribed medications and physician consultations. No specific right/left discrimination training will be provided to the control group.

Follow-up assessments: Participants in the control group will undergo the same follow-up assessments as the intervention group to evaluate changes in pain perception, functional disability, and cognitive function.

Interventions

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Right/left discrimination training

Participants will use recognize app by Neuro-orthopedic institute (NOI) for daily right/left discrimination training.

The training will include visual and auditory stimuli, with tasks such as identifying the laterality of images and sounds.

Participants will engage in training for 20 minutes per day, 5 days per week, over a six-week period.

Weekly monitoring and feedback will be provided by the research team

Intervention Type OTHER

usual care

Usual care: Participants will continue their usual care management for fibromyalgia, including any prescribed medications and physician consultations. No specific right/left discrimination training will be provided to the control group.

Follow-up assessments: Participants in the control group will undergo the same follow-up assessments as the intervention group to evaluate changes in pain perception, functional disability, and cognitive function.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
* Adults between 35 - 55 years old
* Both sexes
* Stable medication use for at least one month prior to enrollment

Exclusion Criteria

* History of other musculoskeletal or neurological disorders
* Current involvement in another pain management program or study
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Fawzy, Ph.d

Role: STUDY_DIRECTOR

Faculty of Physical Therapy, Ahram Canadian University

Locations

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Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed M ElMeligie, Ph.d

Role: CONTACT

+201064442032

Facility Contacts

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Mohamed M ElMeligie, Ph.d

Role: primary

01064442032

Other Identifiers

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012/0059000012

Identifier Type: -

Identifier Source: org_study_id

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