- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07631182
Action Observation Therapy in Chronic Stroke Via Telerehabilitation
Investigation of the Effect of Action Observation Therapy Via Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is defined as a neurological condition caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction, intracerebral or subarachnoid hemorrhage. Stroke is among the leading causes of death and disability worldwide.
Functional impairment in the upper extremities is frequently observed in stroke patients, significantly limiting their grasping and releasing functions, and consequently their daily living activities (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke patients become dependent to varying degrees, negatively impacting their quality of life. Scientists are conducting various studies to find effective, low-cost, and easily applicable methods that can reduce the effects of stroke, which imposes a significant economic, physical, social, and psychological burden on patients and their families, and improve recovery.
Action Observation Therapy (AOT), which involves observing simple actions frequently used in ADL and then imitating those observed actions, is a rehabilitation approach applied in clinical settings in recent years to improve upper extremity function in the rehabilitation of stroke and various neurological diseases. The neural basis of AOT is the mirror neuron system, which is active not only when observing one's own movements but also when observing others' movements. Studies using Functional Magnetic Resonance Imaging have shown that mirror neuron activity increases when observing the movements of others. It is stated that observing an action and then trying to imitate it reduces interhemispheric inhibition, and as a result, it activates the primary motor cortex that causes the observed movement, facilitates the execution of the action, eliminates motor function disorders, and allows for the relearning of functions.
Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation increases the accessibility of physiotherapy interventions in situations where face-to-face rehabilitation is not possible or difficult to access. In stroke patients with a lengthy rehabilitation process, telerehabilitation offers significant advantages, including reduced difficulties in transferring the patient to the healthcare center, shorter travel time, reduced transportation costs, and lower energy costs.
A literature review revealed no studies comparing the effects of AOT delivered via telerehabilitation on upper extremity function, hand skills, daily living activities, and quality of life in patients with chronic stroke compared with conventional physiotherapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mustafa KAVAK, Phd
- Phone Number: +905065089564
- Email: mustafakavak@karabuk.edu.tr
Study Locations
-
-
Merkez
-
Karabük, Merkez, Turkey (Türkiye), 78100
- Recruiting
- Karabuk University
-
Contact:
- Mustafa KAVAK
- Phone Number: 05065089564
- Email: mustafakavak@karabuk.edu.tr
-
Karabük, Merkez, Turkey (Türkiye), 78100
- Recruiting
- Mustafa KAVAK
-
Sub-Investigator:
- Elif Ulukan, PT
-
Contact:
- Mustafa KAVAK, Phd
- Phone Number: +905065089564
- Email: mustafakavak@karabuk.edu.tr
-
Sub-Investigator:
- Cihan Caner Aksoy, Assoc. Professor
-
Sub-Investigator:
- Musa Güneş, Phd
-
Sub-Investigator:
- İlker İlhanlı, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years of age,
- Diagnosis of left hemiparetic stroke,
- Having passed between 6 months since the onset of stroke,
- Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
- Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
- Scoring 24 or more points from the Mini Mental Test
Exclusion Criteria:
- Unwillingness to participate in the study,
- Having spasticity that prevents grasping and releasing an object (levels 3 and 4 on the Modified Ashworth Scale),
- Having a contracture in any of the affected upper extremity joints,
- Having severe neglect disorder (scoring 21 or higher on the Catherine Bergego Scale),
- Having impaired cooperation, compliance, and behavior during the administration of tests used to obtain data,
- Having a mental impairment that prevents communication and following basic commands (scoring less than 24 on the Mini-Mental Test),
- Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance,
- Having severe visual and hearing problems (if any, these problems not corrected with assistive devices such as glasses, contact lenses, hearing aids, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Action observation Therapy
Participants will receive AOT via telerehabilitation in addition to conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
|
All participants will receive conventional physiotherapy, including stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic.
These traditional sessions will be administered by physiotherapists three times a week, each lasting 45 minutes.
|
|
No Intervention: control
Participants will receive only conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spasticity
Time Frame: Baseline
|
Spasticity will assessed using the Modified Ashworth Scale.
As the score increases, spasticity increases.
The minimum score for this scale is 1 and the maximum score is 5.
|
Baseline
|
|
Stage of hemiplegia
Time Frame: Baseline
|
"Brunnstrom Hemiplegia Recovery Staging" will be used to determine the hemiplegic stage of the patients.
This scale is scored between 1 and 6.
As the score increases, the patient improves.
|
Baseline
|
|
Cognitif Function
Time Frame: Baseline
|
Mini Mental Test will be used to evaluate cognitive functions.
In the evaluation, 24-30 points indicate that cognitive functions are normal, 18-23 points indicate mild cognitive impairment, and 17 points and below indicate that cognitive status is severely affected.
|
Baseline
|
|
Neglect
Time Frame: Baseline
|
The Catherine Bergego Scale will be used to assess the impact of unilateral neglect after stroke on activities of daily living.
1-10 indicates mild neglect, 11-20 indicates moderate neglect, and 21-30 indicates severe neglect.
|
Baseline
|
|
Motor function
Time Frame: Baseline, five week later (after intervention)
|
The "Fugl-Meyer Upper Extremity Motor Assessment Scale" will be used to evaluate upper extremity motor functions.
This scale ranges from 0 to 66 points.
As the score increases, motor function improves.
|
Baseline, five week later (after intervention)
|
|
Life Quality
Time Frame: Baseline, five week later (after intervention)
|
The Stroke Specific Quality of Life Scale will be used to assess the quality of life of individuals with stroke.
The higher the total score, the better the quality of life of the individual with stroke.
This scale is scored between 49-245.As the score increases, the quality of life increases.
|
Baseline, five week later (after intervention)
|
|
Dominant side
Time Frame: Baseline
|
The "Edinburgh Hand Preference Test" will be used to determine the dominant side used by the patient in daily life.
It will be used to determine which hand the patient uses more in daily life (Score range: -100 to +100; high positive scores indicate right-handedness, high negative scores indicate left-handedness).
|
Baseline
|
|
Upper extremity function
Time Frame: Baseline, five week later (after intervention)
|
Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test".
It is a widely used clinical test that evaluates upper extremity function (hand and arm) and motor performance.
The test consists of nine wooden sticks with a diameter of 9 millimeters (mm) and a standard wooden block with nine holes of 10 mm diameter.
The patient inserts the nine sticks one by one into the nine holes as quickly as possible, placing them randomly into the holes, and then removes them one by one in the same manner.
The timer is started when the first stick is inserted and stopped when the last stick is removed and released from the hand.
The time taken for the patient to insert and remove the sticks is recorded.
A shorter time indicates better upper extremity function.
|
Baseline, five week later (after intervention)
|
|
Functional Independence
Time Frame: Baseline, five week later (after intervention)
|
Evaluation of upper extremity functions will be done with the "Functional Independence Scale (FIS)".
The is used to assess the change and development in ADL (Applications for Daily Living) depending on the degree of disability experienced by individuals and rehabilitation programs.
Consisting of a total of 18 items, the FIS is divided into two main subcategories: motor domain (FIS-motor; 13 items) and cognitive domain (FIS-cognitive; 5 items).
All activities are rated on a 7-point scale ranging from 1 (requires full assistance during activities) to 7 (performs the activity completely independently).
The total FIS score ranges from 18 to 126 points.
A decrease in the score indicates an increase in the individual's dependence during ADL.
|
Baseline, five week later (after intervention)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mancuso M, Tondo SD, Costantini E, Damora A, Sale P, Abbruzzese L. Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. Brain Sci. 2021 Feb 26;11(3):290. doi: 10.3390/brainsci11030290.
- Shamili A, Hassani Mehraban A, Azad A, Raissi GR, Shati M. Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Trial. Neural Plast. 2022 Sep 16;2022:5284044. doi: 10.1155/2022/5284044. eCollection 2022.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Karabuk-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Stroke
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
Karabuk UniversityRecruitingChronic StrokeTurkey (Türkiye)
-
Marina Castel SánchezNot yet recruiting
-
Zikra AzharRecruitingChronic StrokePakistan
-
University of FaisalabadActive, not recruitingChronic Stroke Survivors | Post-stroke Balance ImpairmentPakistan
-
Sierra Varona SLNot yet recruiting
-
Montiha AzeemRecruitingChronic Ischemic StrokePakistan
-
Riphah International UniversityNot yet recruitingChronic Stroke PatientsPakistan
-
HealthPartners InstituteActive, not recruitingChronic Stroke PatientsUnited States
-
Nisha FazalRecruiting
Clinical Trials on Conventional physiotherapy
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaCompleted
-
Pamukkale UniversityCompletedChronic Low-back PainTurkey
-
Kirsehir Ahi Evran UniversitesiEnrolling by invitation
-
Kutahya Health Sciences UniversityRecruitingAnterior Cruciate Ligament InjuriesTurkey
-
Bezmialem Vakif UniversityCompleted
-
Riphah International UniversityRecruitingLateral EpicondylitisPakistan
-
University of LahoreRecruitingHypotonic Cerebral PalsyPakistan
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus
-
Lokman Hekim UniversityEnrolling by invitation