NCT07565363

Brief Summary

Stroke is one of the leading causes of mortality and disability worldwide. A proportion of individuals who experience a stroke fail to achieve the desired level of motor recovery in the affected upper extremity following rehabilitation, resulting in significant limitations in activities of daily living. After stroke, rehabilitation programs are essential to reduce disability and enhance functional outcomes. This study aims to evaluate whether the addition of Motor Imagery (MI) to a standard rehabilitation program contributes to improvements in upper extremity motor function in individuals with stroke. MI is a mental practice technique in which individuals cognitively rehearse movements without physically performing them. Although the movement is not executed, the brain regions involved in the movement are activated. Eligible participants will be randomly assigned to three groups. All groups will receive a standard physical therapy and rehabilitation program. The first group will receive only standard physical therapy and rehabilitation. The second group will receive, in addition to conventional therapy, 15 minutes of MI training three days per week, while the third group will receive 15 minutes of MI training five days per week. The total treatment duration for all groups is planned as 30 sessions. Assessments will be conducted at baseline, at the end of the treatment period, and again at the 12th week. This study is based on the hypothesis that adding MI practice to a conventional upper extremity rehabilitation program after stroke will contribute to improvements in activities of daily living and functional recovery, and that these effects may be associated with the frequency of the intervention.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Motor Imagery (MI)Upper ExtremityStrokeRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score from baseline assessment

    The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index designed to assess motor function of the upper extremity. The scale evaluates movement, coordination, and reflex activity of the shoulder, elbow, forearm, wrist, and hand. Scores range from 0 to 66, with higher scores indicating better motor function

    Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)

Secondary Outcomes (2)

  • Change in the Modified Barthel Index (MBI) score from baseline assessment.

    Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)

  • Change in the Wolf Motor Function Test (WMFT) score from baseline assessment

    Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)

Study Arms (3)

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Participants will receive a structured, conventional rehabilitation program consisting of range of motion exercises, stretching, strengthening exercises, neuromuscular facilitation techniques, and neurophysiological approaches such as Brunnstrom and Bobath.

Behavioral: Conventional Rehabilitation

Motor Imagery + Conventional Rehabilitation Group 1

EXPERIMENTAL

Participants will receive, in addition to conventional rehabilitation, 15 minutes of motor imagery training three days per week.

Behavioral: Motor Imagery Training 1

Motor Imagery + Conventional Rehabilitation Group 2

EXPERIMENTAL

Participants will receive, in addition to conventional rehabilitation, 15 minutes of motor imagery training five days per week.

Behavioral: Motor Imagery Training 2

Interventions

A structured motor imagery program, applied in addition to conventional rehabilitation, consisting of visual and kinesthetic mental rehearsal of functional movements, delivered for 15 minutes per session, three days per week.

Motor Imagery + Conventional Rehabilitation Group 1

A structured motor imagery program, applied in addition to conventional rehabilitation, consisting of visual and kinesthetic mental rehearsal of functional movements, delivered for 15 minutes per session, five days per week.

Motor Imagery + Conventional Rehabilitation Group 2

A physiotherapy program comprising range of motion exercises, stretching, strengthening exercises, neuromuscular facilitation techniques, and neurophysiological approaches such as Brunnstrom and Bobath.

Also known as: control
Conventional Rehabilitation Group

Eligibility Criteria

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

You may qualify if:

  • Being aged 18 years or older
  • Having a diagnosis of ischemic or hemorrhagic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Being in the late subacute phase (more than 3 months post-stroke) or chronic phase (more than 6 months post-stroke) following stroke onset
  • Presence of unilateral extremity hemiparesis
  • Upper extremity stage between II and V for both proximal and distal segments according to the Modified Brunnstrom Classification
  • A score of 21 or higher on the Mini-Mental State Examination (MMSE)

You may not qualify if:

  • Severe spasticity in the affected upper extremity, defined as a Modified Ashworth Scale score \> 2
  • Presence of impaired consciousness, or severe hearing, visual impairment or global aphasia.
  • Musculoskeletal disorders affecting upper extremity motor function, such as fracture or arthritis in the affected upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Istanbul, 34785, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Elvan Gözügül

CONTACT

Pelin Yıldırım

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations