NCT07631182

Brief Summary

Stroke, a leading cause of disability worldwide, particularly affects upper extremity function, rendering individuals dependent on others for daily living activities and reducing their quality of life. To mitigate these effects, Action Observation Therapy (AOT), which has gained prominence in recent years, activates the mirror neuron system, triggering learning processes in the motor cortex and supporting functional recovery through the imitation of observed movements. Furthermore, telerehabilitation offers a significant advantage in facilitating access to rehabilitation services for these patients requiring long-term treatment, eliminating barriers such as transportation and cost. The absence of studies in the literature comparing the effectiveness of combining these two methods on hand skills and quality of life in individuals with chronic stroke with conventional physiotherapy makes investigating the clinical value of this approach academically unique and necessary.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

16 days

First QC Date

June 1, 2026

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • Spasticity

    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

    "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

  • Motor function

    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)

  • Dominant side

    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

    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

    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)

  • Cognitif Function

    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

    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

  • Life Quality

    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)

Study Arms (2)

Action observation Therapy

EXPERIMENTAL

Participants will receive AOT via telerehabilitation in addition to conventional physiotherapy. They will receive 3 sessions per week for 5 weeks.

Other: Conventional physiotherapy

control

NO INTERVENTION

Participants will receive only conventional physiotherapy. They will receive 3 sessions per week for 5 weeks.

Interventions

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.

Action observation Therapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karabuk University

Karabük, Merkez, 78100, Turkey (Türkiye)

RECRUITING

Mustafa KAVAK

Karabük, Merkez, 78100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

Related Links

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
There will be different researchers: the evaluator, the administrator, and the statistical analyst. Neither the evaluator nor the statistical analyst will know which group the participants belong to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations