NCT06326749

Brief Summary

In the study, movement observation training, Modified Graded Motor Imaging Training, which includes upper extremity functional exercises, and Graded Motor Imaging Training, where the standard protocol is applied, will be used in stroke patients to improve their upper extremity motor functions and daily lives. It is aimed to present it on an evidence-based basis by investigating its effects on Daily Living Activity, quality of life, upper extremity-specific right/left lateralization performance, mental stopwatch performance and motor imagery skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 10, 2024

Last Update Submit

March 13, 2026

Conditions

Keywords

graded motor imageryaction observation trainingStrokehemiplegiaupper limb functionactivities of daily livinglife quality

Outcome Measures

Primary Outcomes (4)

  • Fugl-Meyer Upper Extremity Motor Rating Scale

    The scale is a widely used, reliable and valid test to evaluate paretic upper extremity motor impairment in stroke patients. From this scale, where each parameter is scored between 0-2 points, a maximum score of 66 can be obtained, and high scores indicate good motor functions.

    before treatment, 2 months, 4 months

  • Wolf Motor Function Test (WMFT)

    WMFT is used to evaluate motor skill in patients with upper extremity motor dysfunction. The 15 functional activities evaluated are scored between 0-5 points and the functional skill score is calculated by taking the average of the total score. Higher scores indicate better functional ability. In the performance time section, how long each activity took is recorded. A maximum of 120 seconds is allowed to complete an activity. If the activity cannot be completed within this time, the performance time is recorded as 120 seconds.

    before treatment, 2 months, 4 months

  • Modified Barthel Index

    MBI, which is used to measure the independence of individuals in daily living activities, emerged by modifying the Barthel Index. MBI includes 10 items related to activities of daily living. Total score is between 0-100. As the score increases, individuals' independence in daily living activities increases.

    before treatment, 2 months, 4 months

  • Stroke-Specific Quality of Life Scale

    It consists of a total of 49 items for 12 subcategories (mobility, fitness, upper extremity functionality, work/productivity, mood, self-care, social roles, family roles, language, vision, thinking and personality) that evaluate the quality of life of individuals with stroke. The higher the total score, the better the stroke individual's quality of life.

    before treatment, 2 months, 4 months

Secondary Outcomes (3)

  • Lateralization Assessment

    before treatment, 2 months, 4 months

  • Mental Chronometry Time

    before treatment, 2 months, 4 months

  • Kinesthetic and Visual Imagery Questionnaire (KGIA)

    before treatment, 2 months, 4 months

Study Arms (3)

Modified Graded Motor Imagery and Conventional Treatment Group:

EXPERIMENTAL

The modified DMI program consists of 4 stages: lateralization, open motor imagery including action observation training, mirror therapy and upper extremity functional exercise. The program will be implemented for 8 weeks, 3 days a week, under the supervision of a physiotherapist. Lateralization training will be applied in the first 2 weeks. Motor imagery training will be implemented in the 3rd and 4th weeks. For the second stage, the application will be combined with action observation training. As the 3rd stage, mirror therapy will be performed in the 5th and 6th weeks. The participant will be asked to perform some exercises while watching the reflection of the intact extremity in the mirror. In the final stage, they will be asked to physically perform upper extremity functional exercises. The total treatment time will be 40-50 minutes, with patients receiving 20-30 minutes of modified grade motor imagery and 20 minutes of conventional treatment.

Other: Modified Graded Motor Imagery and Conventional Treatment Group

Graded Motor Imagery and Conventional Treatment Group:

EXPERIMENTAL

The DMI program consists of 3 stages: lateralization, open motor imagery and mirror therapy. The program will be implemented for 8 weeks, 3 days a week, under the supervision of a physiotherapist. First, lateralization training will be applied. In the second stage, motor imagery training will be applied. This phase will be carried out in a quiet environment by asking the participants to fully focus on the visualization of the movements. Two methods will be used for the imagined movements. In particular, visuals of the shoulder and hand used in the lateralization phase will be used to visualize movements related to the normal movement of the upper extremity. Participants will also be asked to imagine different activities in daily life. In the final stage, mirror therapy will be applied. The participant will be asked to perform some exercises while watching the reflection of the intact extremity in the mirror.

Other: Graded Motor Imagery and Conventional Treatment Group

Conventional Treatment Group:

EXPERIMENTAL

Within the scope of the conventional treatment Bobath Method, facilitating movement and functional activities in the upper and lower extremities, activating trunk muscles, facilitating basic functional activities such as turning in bed, coming to sit and standing, improving weight bearing while sitting and standing, postural control, balance and walking. A targeted exercise program will be created. In line with this goal, upper and lower extremity exercises; don't turn around, don't come to sit, don't stand up; Exercises to activate core muscles; such as bridging, functional reaching; weight bearing and balance training; It is planned to implement walking training. Treatment time will be 40-50 minutes.

Other: Conventional Treatment Group

Interventions

A modified form of graded motor imagery training and conventional rehabilitation will be applied.

Modified Graded Motor Imagery and Conventional Treatment Group:

Graded motor imagery training and conventional rehabilitation will be applied.

Graded Motor Imagery and Conventional Treatment Group:

conventional rehabilitation will be applied.

Conventional Treatment Group:

Eligibility Criteria

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

You may qualify if:

  • Hemiplegia was observed after CVO, According to the Edinburgh Handedness Questionnaire, those who actively use their right extremity, Those with right hemisphere involvement, Those aged 18 and over, Having been diagnosed with stroke at least 1 month ago and at most 6 months ago, Middle cerebral artery involvement, Having a Standardized Mini Mental Test score of 24 or above, having a Stage 2b or above according to Eggers staging, Able to actively control hands, wrists and fingers and perform the release reflex Those who want to participate in the study voluntarily and Individuals with informed consent will be included in the study.

You may not qualify if:

  • Those with major neurological, orthopedic or rheumatological disorders that affect upper extremity function other than stroke (Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.).
  • Those with upper extremity amputation, Uncontrolled arrhythmia, uncontrolled hypertension, unstable cardiac status Active malignancy and receiving chemo/radiotherapy related to it Uncooperative due to aphasia or cognitive impairment Individuals with vision and hearing problems Having a communication problem that may prevent implementation of the evaluations and/or treatment program Individuals who do not allow mental evaluation, cannot fill out the scales, and are illiterate will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (3)

  • Braun N, Kranczioch C, Liepert J, Dettmers C, Zich C, Busching I, Debener S. Motor Imagery Impairment in Postacute Stroke Patients. Neural Plast. 2017;2017:4653256. doi: 10.1155/2017/4653256. Epub 2017 Mar 28.

    PMID: 28458926BACKGROUND
  • Candiri B, Talu B, Guner E, Ozen M. The effect of graded motor imagery training on pain, functional performance, motor imagery skills, and kinesiophobia after total knee arthroplasty: randomized controlled trial. Korean J Pain. 2023 Jul 1;36(3):369-381. doi: 10.3344/kjp.23020. Epub 2023 Jun 22.

    PMID: 37344366BACKGROUND
  • Yu JA, Park J. The effect of first-person perspective action observation training on upper extremity function and activity of daily living of chronic stroke patients. Brain Behav. 2022 May;12(5):e2565. doi: 10.1002/brb3.2565. Epub 2022 Apr 10.

    PMID: 35398981BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 22, 2024

Study Start

June 15, 2024

Primary Completion

June 15, 2025

Study Completion

July 30, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations