NCT07546864

Brief Summary

This study aims to compare the effectiveness of three rehabilitation approaches in individuals with stroke: mirror therapy (MT), cognitive orientation to daily occupational performance (CO-OP), and conventional occupational therapy (COT), all combined with robotic balance training. A total of 45 individuals with subacute and chronic stroke will be randomly assigned to one of three groups. Each group will receive 4 weeks of intervention (5 sessions per week), followed by a 3-month follow-up period. Outcomes related to motor function, somatosensory function, activities of daily living, participation, and quality of life will be assessed at baseline, after intervention, and at follow-up. The study aims to determine which intervention approach is more effective in improving functional outcomes in individuals with stroke.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
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 Progress17%
Feb 2026Jun 2027

Study Start

First participant enrolled

February 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 17, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

mirror therapyRandomized Controlled TrialStrokeCognitive Orientation to Daily Occupational Performance Occupational Therapysomatosensoryparticipationactivity daily of lifeoccupational therapy

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Motor Assessment (FMA)

    The Fugl-Meyer Assessment will be used to evaluate motor function in individuals with stroke. Higher scores indicate better motor function.

    Baseline, post-intervention (4 weeks), and 3-month follow-up

Secondary Outcomes (6)

  • Revised Nottingham Sensory Assessment (rNSA)

    Baseline, post-intervention (4 weeks), and 3-month follow-up

  • Canadian Occupational Performance Measure (COPM)

    Baseline, post-intervention (4 weeks), and 3-month follow-up

  • Modified Barthel Index (MBI)

    Baseline, post-intervention (4 weeks), and 3-month follow-up

  • Stroke Impact Scale (SIS)

    Baseline, post-intervention (4 weeks), and 3-month follow-up

  • Stroke Self-Efficacy Questionnaire (SSEQ)

    Baseline, post-intervention (4 weeks), and 3-month follow-up

  • +1 more secondary outcomes

Study Arms (3)

Mirror Therapy Group

EXPERIMENTAL

Participants in this group will receive mirror therapy combined with robotic balance training. Mirror therapy will be applied using task-oriented activities involving upper and lower extremities based on individual needs. Intervention will be administered 5 days per week for 4 weeks. A transfer package will also be applied.

Behavioral: Mirror TherapyOther: Robotic Balance Training

CO-OP Group

EXPERIMENTAL

Participants in this group will receive cognitive orientation to daily occupational performance (CO-OP) combined with robotic balance training. Individualized goals will be determined and cognitive strategies will be used to improve task performance. Intervention will be administered 5 days per week for 4 weeks. A transfer package will also be applied.

Behavioral: Cognitive Orientation to Daily Occupational Performance (CO-OP)Other: Robotic Balance Training

Conventional Occupational Therapy Group

ACTIVE COMPARATOR

Participants in this group will receive conventional occupational therapy combined with robotic balance training. The intervention will include task-oriented activities such as reaching, grasping, coordination, and strengthening exercises. Intervention will be administered 5 days per week for 4 weeks. A transfer package will also be applied.

Behavioral: Conventional Occupational TherapyOther: Robotic Balance Training

Interventions

Mirror TherapyBEHAVIORAL

Mirror therapy involves the use of a mirror to create a visual illusion of movement of the affected limb by observing the reflection of the unaffected limb. Task-oriented activities are performed to improve motor function and sensory integration in individuals with stroke.

Mirror Therapy Group

CO-OP is a client-centered, performance-based approach that uses cognitive strategies to enable skill acquisition. Participants identify meaningful goals and use guided discovery and problem-solving strategies to improve task performance.

CO-OP Group

Conventional occupational therapy includes task-oriented interventions such as reaching, grasping, coordination training, strengthening exercises, and activities aimed at improving functional independence in daily living.

Conventional Occupational Therapy Group

Robotic balance training is used as a priming intervention before therapy sessions. It includes repetitive, task-specific movements involving weight shifting, postural control, and balance training to enhance motor responses.

CO-OP GroupConventional Occupational Therapy GroupMirror Therapy Group

Eligibility Criteria

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

You may qualify if:

  • \- Individuals diagnosed with ischemic or hemorrhagic stroke
  • Age 18 years and older
  • Subacute (3-6 months post-stroke) or chronic stage (6-12 months post-stroke)
  • Brunnstrom Motor Recovery Stage ≥3 for upper extremity, ≥4 for hand, and ≥4 for lower extremity
  • Mini-Mental State Examination (MMSE) score ≥24
  • No severe visual, orthopedic, or additional neurological impairments
  • Not participating in another study during the research period
  • Voluntary consent to participate in the study

You may not qualify if:

  • \- Poor motor coordination or major medical problems that would prevent participation
  • Presence of Wernicke's aphasia
  • Botulinum toxin injection within the last 3 months
  • Psychiatric conditions that may interfere with participation (e.g., depression, ongoing psychiatric treatment, low motivation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt State Hospital

Bayburt, Merkez, 69000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Gokcen Akyurek, Associate Professor

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

NURTEN BİLGİN, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Bu açık etiketli bir çalışmadır. Uygulanan müdahalelerin niteliği nedeniyle herhangi bir körleme yöntemi kullanılmamıştır.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups: mirror therapy (MT), cognitive orientation to daily occupational performance (CO-OP), or conventional occupational therapy (COT). All groups will receive robotic balance training prior to intervention sessions. Interventions will be applied for 4 weeks, followed by a 3-month follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 15, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations