Effects of Telerehabilitation-Based Motor Imagery Training on Pain in People With Multiple Sclerosis

NCT ID: NCT05326711

Last Updated: 2023-07-11

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2022-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this studly, the effects of an 8-week telerehabilitation-based motor imagery training on pain and related factors in persons with multiple sclerosis will be investigated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Multiple sclerosis (MS) is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include motor dysfunction, fatigue, spasticity, cognitive impairment, depression, decreased quality of life, bladder and bowel dysfunction and pain. People with Multiple Sclerosis (pwMS) show a wide range of pain symptoms, from acute pain symptoms to chronic pain symptoms. Pain is an important symptom in pwMS and is often associated with disability. Pain is a fairly common symptom in pwMS. The prevalence of pain in MS was found to be 63%. In addition, 30% of pwMS describe pain as their most severe symptom.

In the studies, it was found that motor imagery training, which is defined as imagining movement without revealing the movement in reality, is a training at the cortical level and reduces pain by creating positive effects on the impaired body schema perception. However, the effect of motor imagery training on pain in pwMS has not been investigated before.

For this reason, the aim of this study is to investigate the effect of telerehabilitation-based motor imagery training protocol, guidance of a physiotherapist, on pain, fatigue, anxiety, depression, quality of life and sleep quality in pwMS.

Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 32 participants will randomly be divided into 2 groups. (1) Telerehabilitation-based motor imagery training, (2) Control group. Telerehabilitation-based motor imagery training group will individually receive telerehabilitation-based motor imagery training under the guidance of a physiotherapist for 8 weeks.

The first 2 weeks of the treatment period, will reserved for implicit motor imagery / lateralization training. It will be performed by the "noi group application" application that can be downloaded to the participants' mobile devices (smartphone or tablet). Lateralization training will be aimed at the initially evaluated areas of the participants (neck, back, shoulder, knee, hand/wrist, foot/ankle) that have a pain level of at least 30 mm according to the Visual Pain Scale (VAS). In the application, the participants will be asked to discriminant right and left with simple photographs of the painful areas determined at the beginning, and more complex photographs will be used as the training progresses. Participants will be asked to use the app 3 times a day. In each application session, the right / left discrimination of the region in the photograph will be requested within 5 seconds and 30 photographs will be shown for each painful region. Each session will last 2-3 minutes on average, depending on the number of painful areas of the participants. Controls will be made over the results sent to the e-mail address of the physiotherapist through the application. For 3rd to 8th weeks of the treatment period telehabilitation-based motor imagery training will be given to the participants individually, in synchronization, using the Google Meet videoconference platform, under the guidance of a physiotherapist. Participants will participate the treatment with their smart phones, tablets or computers that have an active internet connection and are suitable for meeting via videoconference. The duration of the sessions will last 20-30 minutes.

The control group will not receive treatment other than their routine treatment, and the patients will be informed that the control group participants will be treated if the participants wish at the end of the study. The assessments will be applied at baseline, 8, and 12 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telerehabilitation-based motor imagery training

The first 2 weeks of the treatment period, will reserved for implicit motor imagery / lateralization training. It will be performed by the "noi group application" application that can be downloaded to the participants' mobile devices. Participants will be asked to use the app 3 times a day. In each application session, the right / left discrimination of the region in the photograph will be requested within 5 seconds and 30 photographs will be shown for each painful region. Each session will last 2-3 minutes on average. For 3rd to 8th weeks of the treatment period telehabilitation-based motor imagery training will be given to the participants individually, in synchronization, using the Google Meet videoconference platform, under the guidance of a physiotherapist. The duration of the sessions will last 20-30 minutes.

Group Type EXPERIMENTAL

Telerehabilitation-based motor imagery training

Intervention Type BEHAVIORAL

Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies".

Control

No specific intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telerehabilitation-based motor imagery training

Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies".

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Having been diagnosed with MS according to McDonald diagnostic criteria
* Not having an attack in the last 3 months.
* To have sufficient smartphone/tablet or computer knowledge to participate in the study or to have a relative who can help in this regard.
* Having an active internet connection at home.
* Having a smart phone/tablet or computer suitable for videoconferencing.
* Having a smartphone or tablet.
* Having a pain level of at least 30 mm on the 100 mm visual analog scale (VAS) for at least 3 months in at least one of the hand/wrist, foot/ankle, knee, shoulder, neck and back regions.
* No change in medications used for pain in the last 2 months.
* Not receiving additional treatment other than routine treatments.
* To be able to read and understand Turkish.

Exclusion Criteria

* Pregnancy
* Having a musculoskeletal, cardiovascular, pulmonary, metabolic, or other disease severe enough to preclude participation in the study.
* Presence of conditions other than MS that can cause pain, such as cancer, diabetes, overt osteoarthritis, or rheumatoid arthritis based on laboratory or imaging findings
* Having a psychiatric illness.
* Presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed
* Having severe vision and hearing problems.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Katip Celebi University

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Turhan Kahraman

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, Inciralti, Turkey (Türkiye)

Site Status

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/29-24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Modulation of Painful Perception
NCT02528578 COMPLETED NA