NCT05326711

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

November 16, 2021

Last Update Submit

July 9, 2023

Conditions

Keywords

multiple sclerosismotor imagerypaintelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale (VAS) Score

    VAS will be used to numerically determine the general pain intensities felt by participants in the last 2 days and the pain intensities of the areas they feel painful on six regions: neck, shoulder, back, hand/wrist, knee, foot/ankle. Participants will be told that 0mm above the 100mm line had "no pain"; It will be stated that 100 mm represents "the most unbearable pain". The degree of pain will be recorded numerically between 0 and 100.

    The assessments will be applied at baseline, 8, and 12 weeks.

Secondary Outcomes (15)

  • Expanded Disability Status Scale

    The assessment will be applied at baseline.

  • Change in Patient-Determined Disease Steps Scale Score

    The assessments will be applied at baseline and 8 weeks.

  • Change in Numeric Rating Scale Score

    The assessments will be applied at baseline, 8, and 12 weeks

  • Change in PainDETECT Questionnaire Score

    The assessments will be applied at baseline, 8, and 12 weeks

  • Change in Nordic Musculoskeletal Questionnaire Score

    The assessments will be applied at baseline, 8, and 12 weeks

  • +10 more secondary outcomes

Study Arms (2)

Telerehabilitation-based motor imagery training

EXPERIMENTAL

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.

Behavioral: Telerehabilitation-based motor imagery training

Control

NO INTERVENTION

No specific intervention

Interventions

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

Telerehabilitation-based motor imagery training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, Inciralti, 35340, Turkey (Türkiye)

Location

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, 35430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisPain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

November 16, 2021

First Posted

April 13, 2022

Study Start

April 11, 2022

Primary Completion

November 21, 2022

Study Completion

November 21, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations