NCT07887776

Brief Summary

This study aims to investigate the impact of cognitive impairment on upper extremity physical performance, cognitive skills, and functional independence in individuals with chronic stroke. A total of 66 chronic stroke survivors will be enrolled and categorized into two groups based on their Montreal Cognitive Assessment (MoCA) scores: the Cognitive Impairment Group (n=33) and the Control Group (n=33). Upper extremity performance, cognitive functions, and functional independence will be comprehensively evaluated using standardized clinical outcome measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

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

Study Start

First participant enrolled

January 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1.5 years

First QC Date

October 15, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

Cronic strokecognitive impairmentupper extremitymotor performancefunctional independence

Outcome Measures

Primary Outcomes (4)

  • Wolf Motor Function Test (WMFT) Performance Time

    valuates upper extremity motor ability and functional performance through timed and functional tasks. WMFT performance time is measured in seconds, where longer durations indicate lower performance.

    Baseline (Single assessment session)

  • Fugl-Meyer Upper Extremity Assessment (FM-UE) Score

    Measures motor recovery, reflex activity, and movement coordination in the upper extremity. Scores range from 0 to 66, with higher scores indicating better motor function.

    Baseline (Single assessment session)

  • Box and Block Test (BBT) Score

    Assesses unilateral manual dexterity. It measures the number of blocks transported from one compartment to another within 60 seconds (evaluated separately for affected and unaffected upper extremities).

    Baseline (Single assessment session)

  • Functional Independence Measure (FIM) Motor and Cognitive Sub-scores

    Evaluates the level of independence in activities of daily living. It consists of motor and cognitive sub-scales, where higher scores reflect greater functional independence.

    Baseline (Single assessment session)

Secondary Outcomes (2)

  • Stroop Test Completion Times

    Baseline (Single assessment session)

  • Forward and Backward Digit Span Test Scores

    Baseline (Single assessment session)

Study Arms (2)

Cognitive Impairment Group

Scoring 20 or lower on the Montreal Cognitive Assessment (MoCA)

Control Group

Scoring 21 or higher on the Montreal Cognitive Assessment (MoCA)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises adult patients of both genders, aged between 18 and 80 years, who have experienced a single ischemic or hemorrhagic stroke at least six months prior to enrollment (chronic stroke phase). Participants are recruited from outpatient physical therapy and rehabilitation clinics. Based on their cognitive screening using the Montreal Cognitive Assessment (MoCA), the study population is categorized into two comparative cohorts: a Cognitive Impairment Group and a Control Group. Eligible participants must be able to communicate effectively, be literate, and have no pre-existing cognitive disorders, severe medical comorbidities, or concurrent neurological/orthopedic conditions that could independently affect physical or cognitive performance.

You may qualify if:

  • History of ischemic or hemorrhagic stroke diagnosed at least 6 months prior to the study,
  • First-ever stroke
  • Absence of communication or language disorders that would prevent understanding and cooperation
  • Ability to read and write
  • Not currently receiving psychotropic medication treatment
  • Willingness to participate and provision of signed informed consent

You may not qualify if:

  • Having a chronic and severe medical condition (e.g., epilepsy, cerebral palsy)
  • Presence of any other concurrent orthopedic or neurological disease affecting physical or cognitive performance
  • History of recent surgery
  • History of any pre-existing condition affecting cognitive status (e.g., dementia, neurodegenerative diseases)
  • Complete loss of vision or hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doç. Dr. Mustafa Kalemli Tavsanli State Hospital

Kütahya, Tavşanlı, 43300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assit. Prof.

Study Record Dates

First Submitted

October 15, 2026

First Posted

October 21, 2026

Study Start

January 1, 2025

Primary Completion

June 30, 2026

Study Completion

July 1, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Locations