NCT06295601

Brief Summary

This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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

February 21, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

February 21, 2024

Last Update Submit

March 4, 2024

Conditions

Keywords

motor imagerytelerehabilitationaction observation therapy

Outcome Measures

Primary Outcomes (4)

  • Berg Balance Scale

    Berg Balance Scale consists of a total of 14 items. Evaluation for each stage is made between 0-4. Higher score indicates better functional balance performance

    Baseline

  • Berg Balance Scale

    Berg Balance Scale consists of a total of 14 items. Evaluation for each stage is made between 0-4. Higher score indicates better functional balance performance

    6 weeks after baseline

  • Muscle strength and functional mobility

    The participant will be asked to sit and stand up from a standard chair between 42-45 cm, with hands crossed on the chest, without support, 5 times. The time will be stopped when the participant completes the last sitting. It will be recorded in seconds.

    Baseline

  • Muscle strength and functional mobility

    The participant will be asked to sit and stand up from a standard chair between 42-45 cm, with hands crossed on the chest, without support, 5 times. The time will be stopped when the participant completes the last sitting. It will be recorded in seconds.

    6 weeks after baseline

Secondary Outcomes (4)

  • Fatigue Severity Scale

    Baseline

  • Fatigue Severity Scale

    6 weeks after baseline

  • Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire

    Baseline

  • Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire

    6 weeks after baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Individuals will receive standard rehabilitation and telerehabilitation-based motor imagery and action observation therapy.

Other: Traditional rehabilitationOther: Action observation therapy and motor imagery

Control group

EXPERIMENTAL

Individuals will receive standard rehabilitation.

Other: Traditional rehabilitation

Interventions

The program consists of a joint treatment in which lower extremity strengthening and balance exercises are carried out synchronously. The program will include a total of 5 minutes of warm-up, 5 minutes of cool-down and 30 minutes of exercises related to the program. The difficulty of the program will increase by changing the number of exercises and increasing the weight in strengthening exercises. Progress in balance and coordination exercises will vary by changing the ground, increasing the standing time, and keeping the eyes open and closed.

Control groupExperimental group

In the experimental group, in addition to traditional telerehabilitation, action observation and motor imagery of 4 exercises will be performed in each session. A video will be prepared for 4 exercises. Then, the participant will perform 2 minutes of action observation of each movement, followed by 1 minute of motor imagery. In addition to the traditional telerehabilitation program, a 12-minute combination of action observation and motor imagery will be performed in each session. Exercises will be changed every two weeks, gradually increasing the difficulty.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with mulltiple sclerosis according to the McDonald criteria
  • Expanded Disability Status Scale\<5.5,
  • Being between the ages of 18-65,
  • Mini mental test score\>24,
  • Have a phone that can adapt to participating in a video call

You may not qualify if:

  • Having another additional neurological disease that may cause balance and coordination disorders,
  • Receiving physical therapy in the last 6 months,
  • Having an attack in the last 3 months
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Burcu talu

    Inonu University

    STUDY DIRECTOR

Central Study Contacts

Dilan DEMIRTAS KARAOBA

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 6, 2024

Study Start

March 20, 2024

Primary Completion

February 15, 2025

Study Completion

August 15, 2025

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Study data can be shared with other researchers if desired.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After the study was published
Access Criteria
If requested from the authors, it can be shared with researchers at the authors' discretion.