NCT06501014

Brief Summary

The goal of this clinical trial is to learn the effectiveness of action observation therapy in patients with stroke. The main questions it aims to answer are: Is action observation therapy an effective method in stroke patients? Researchers will compare the results of two action observation-based exercises (home program) with conventional exercise to see whether action observation therapy works in the rehabilitation of stroke patients. Participants: Participants in one group will do action observation-based exercise (home plus conventional exercise for 24 sessions, Patients in the control group will only undergo conventional exercise in addition to routine treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 16, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 10, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

July 8, 2024

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 2 minute walk test

    Patients will be asked to walk 30 meters long on a flat surface for 2 minutes. When the time is up, the distance the patient can walk will be recorded.

    The evaluation will be applied at the baseline and after study completion, an average of 2 months.

  • Fugl-Meyer Assessment

    The FMA motor assessments for the lower extremity (minimum score:0 and maximum score 34 points) will be applied. A higher score means the patient's motor movements are better.

    The evaluation will be applied at the baseline and after study completion, an average of 2 months.

  • Berg Balance Scale

    The Berg Balance Scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of funcion.

    The evaluation will be applied at the baseline and after study completion, an average of 2 months.

Study Arms (2)

Action Observation Therapy-Experimental Group

EXPERIMENTAL

Patients will be asked to watch the exercises before doing them. For each exercise, patients will first watch the relevant video and do the exercise after the video ends.

Other: Action Observation Therapy-Experimental Group

Conventional Exercises-Control Group

ACTIVE COMPARATOR

Patients will be subjected to conventional exercise only.

Other: Conventional Exercises-Control Group

Interventions

Patients will be asked to watch the exercises before doing them.For each exercise, patients will first watch the relevant video and do the exercise after the video ends.

Action Observation Therapy-Experimental Group

Patients will be subjected to conventional exercise only.

Conventional Exercises-Control Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke patients in the chronic phase (more than 6 months have passed since the stroke)
  • Patients over 40 years of age
  • Patients who can stand and walk independently (including those using walking aids)

You may not qualify if:

  • Additional disease (neurological, orthopedic, etc.) that may affect motor performance and balance.
  • Patients with communication problems
  • Patients with mental problems (mini-mental test score \<23)
  • Patients aged 85 and over

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Osman Karaca, PhD

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

July 16, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations