StrokeNCT07881471
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
An observational study of Stroke and Ideomotor Apraxia, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
After a stroke, some people have difficulty planning and carrying out familiar movements. This difficulty is called ideomotor apraxia and cannot be explained by muscle weakness alone. It may influence how people improve during rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Ideomotor Apraxia, Hemiplegia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2026to 30 Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with clinically and radiologically confirmed ischemic or hemorrhagic stroke receiving inpatient rehabilitation at the Physical Medicine and Rehabilitation Clinic of Izmir City Hospital and scheduled for routine RehaWalk-supported gait rehabilitation. Eligible patients who provide written informed consent will be enrolled consecutively. Participants will be classified into cohorts with or without ideomotor apraxia according to baseline TULIA scores.
Who may be able to join
- Age 18 years or older.
- Clinically and radiologically confirmed ischemic or hemorrhagic stroke.
- Scheduled to receive robotic gait rehabilitation as part of routine clinical care.
- At least 1 month since stroke onset.
- Ability to walk at least 10 meters with or without an assistive device.
- Ability to stand independently or under supervision for at least 2 minutes.
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- Brunnstrom lower extremity recovery stage of 3 or higher.
- Modified Ashworth Scale score below 3 for the plantar flexor muscle group.
- Sufficient upper extremity motor function to permit TULIA assessment, defined as a Fugl-Meyer Assessment upper extremity motor score of at least 20.
- Sufficient cognitive ability to understand the study assessments, defined as a Mini-Mental State Examination score of at least 18.
- Ability to understand the informed consent form and provide written informed consent.
Who cannot join
- Failure to provide written informed consent or withdrawal of consent.
- Severe aphasia or advanced cognitive impairment preventing understanding or completion of the study assessments.
- Severe unilateral neglect.
- Cerebellar stroke.
- Parkinson's disease, multiple sclerosis, motor neuron disease, or another neurological disorder that may affect walking.
- Orthopedic disease or previous surgery substantially affecting lower extremity function, including advanced osteoarthritis, lower extremity amputation, unhealed fracture, or severe contracture.
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- Severe plantar flexor spasticity, defined as a Modified Ashworth Scale score of 3 or higher.
- Cardiovascular or systemic disease preventing safe participation in robotic gait rehabilitation, including unstable angina, uncontrolled arrhythmia, decompensated heart failure, uncontrolled hypertension, acute infection, or severe respiratory failure.
- Conditions preventing safe use of the gait rehabilitation system, including inability to use the safety belt or suspension system appropriately, severe lower extremity deformity, serious skin lesions or pressure ulcers, or height or body weight outside the manufacturer's specified limits.
- Severe visual or hearing impairment preventing reliable administration of the assessments.
- Any condition judged by the investigator to make participation unsafe or prevent compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ideomotor Apraxia on the Outcomes of Robotic Gait Rehabilitation in Patients With Stroke: A Prospective Observational Study
After a stroke, some people have difficulty planning and carrying out familiar movements. This difficulty is called ideomotor apraxia and cannot be explained by muscle weakness alone. It may influence how people improve during rehabilitation.
This study will examine whether ideomotor apraxia is associated with changes in walking, balance, and independence in adults receiving rehabilitation after stroke at Izmir City Hospital.
Read more
Participants will be assessed for apraxia before rehabilitation and followed during their usual rehabilitation program, which includes conventional rehabilitation and RehaWalk-supported gait training. Walking and other functional abilities will be evaluated before and after the rehabilitation program. Changes will be compared between participants with and without apraxia.
The study will observe routine care. Participants will not be assigned to different treatments, and no experimental treatment will be provided. The findings may help clinicians understand whether apraxia is useful for predicting rehabilitation outcomes after stroke.
Read the detailed description
This single-center, prospective observational cohort study will investigate the prognostic association between baseline ideomotor apraxia and functional changes following routine conventional rehabilitation and RehaWalk-supported gait rehabilitation in adults with stroke at Izmir City Hospital.
Ideomotor apraxia will be assessed before rehabilitation using the Test of Upper Limb Apraxia (TULIA; score range 0-240). Participants scoring below 194 will form the apraxia cohort and those scoring 194 or above the non-apraxia cohort. TULIA scores will also be analyzed as a continuous measure to examine the relationship between apraxia severity and functional gains.
Rehabilitation will be delivered according to routine clinical practice: conventional inpatient rehabilitation plus RehaWalk-supported gait training, 3 sessions per week for up to 5 weeks (15 sessions, 30 minutes each). Participants completing at least 12 sessions will be included in the analysis. The study will not assign treatment, introduce an additional rehabilitation method, or provide an experimental intervention.
Assessments will be performed at baseline and after the 15th session or at discharge, whichever comes first. TULIA will be administered by a physician investigator and recorded separately; outcome assessors will be blinded to apraxia group status.
Functional changes will be compared between cohorts. Multivariable linear regression will examine whether baseline apraxia is independently associated with change in gait speed after adjusting for age, time since stroke, lesion side, baseline motor function, baseline 10-Meter Walk Test and number of completed sessions.
- Conditions
- Stroke, Ideomotor Apraxia, Hemiplegia
- Keywords
- Stroke Rehabilitation, RehaWalk, Test of Upper Limb Apraxia, TULIA, Walking Speed, Balance, Functional Independence, Prognosis
- Medical subject headings
- Stroke, Apraxia, Ideomotor, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke With Ideomotor Apraxia | Adults with stroke whose baseline Test of Upper Limb Apraxia (TULIA) total score is below 194. Participants receive routine conventional rehabilitation and RehaWalk-supported gait rehabilitation. | |
| Stroke Without Ideomotor Apraxia | Adults with stroke whose baseline Test of Upper Limb Apraxia (TULIA) total score is 194 or above. Participants receive routine conventional rehabilitation and RehaWalk-supported gait rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Speed on the 10-Meter Walk Test
Walking speed will be assessed using the 10-Meter Walk Test and expressed in meters per second. Change will be calculated as the post-rehabilitation value minus the baseline value. Positive values indicate improved walking speed. Changes will be compared between participants with ideomotor apraxia (baseline TULIA score below 194) and those without ideomotor apraxia (baseline TULIA score of 194 or above).
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Secondary outcomes (11)
Change in Berg Balance Scale Score
Functional balance will be assessed using the 14-item Berg Balance Scale. Total scores range from 0 to 56, with higher scores indicating better balance. Change will be calculated as the post-rehabilitation score minus the baseline score. Positive changes indicate improvement and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in Timed Up and Go Test Time
Functional mobility will be assessed by measuring the time in seconds required to rise from a chair, walk 3 meters, turn, walk back, and sit down. Change will be calculated as the post-rehabilitation time minus the baseline time. Negative changes indicate improved functional mobility and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in Functional Ambulation Categories Score
Walking independence will be assessed using the Functional Ambulation Categories. Scores range from 0 to 5, with higher scores indicating greater walking independence. Change will be calculated as the post-rehabilitation score minus the baseline score. Positive changes indicate improvement and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in Functional Independence Measure Total Score
Functional independence will be assessed using the 18-item Functional Independence Measure. Total scores range from 18 to 126, with higher scores indicating greater independence. Change will be calculated as the post-rehabilitation score minus the baseline score. Positive changes indicate improvement and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in Fugl-Meyer Assessment Lower Extremity Motor Score
Lower extremity motor function will be assessed using the lower extremity motor domain of the Fugl-Meyer Assessment. Scores range from 0 to 34, with higher scores indicating better motor function. Change will be calculated as the post-rehabilitation score minus the baseline score. Positive changes indicate improvement and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in RehaWalk-Measured Gait Speed
Gait speed recorded by the RehaWalk system will be expressed in meters per second. Change will be calculated as the post-rehabilitation value minus the baseline value. Positive changes indicate increased gait speed. Changes will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in RehaWalk-Measured Cadence
Cadence recorded by the RehaWalk system will be expressed in steps per minute. Change will be calculated as the post-rehabilitation value minus the baseline value. Changes will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in RehaWalk-Measured Step Length
Step length recorded by the RehaWalk system will be expressed in centimeters. Change will be calculated as the post-rehabilitation value minus the baseline value. Changes will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in RehaWalk-Measured Step Symmetry Index
Step symmetry between the paretic and non-paretic sides will be assessed using the symmetry index recorded by the RehaWalk system and expressed as a percentage, with 0% indicating perfect symmetry. Change will be calculated as the post-rehabilitation value minus the baseline value. Negative changes indicate improved symmetry and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in RehaWalk-Measured Double Support Time
Double support time, representing the portion of the gait cycle during which both feet are in contact with the walking surface, will be recorded by the RehaWalk system and expressed as a percentage of the gait cycle. Change will be calculated as the post-rehabilitation value minus the baseline value. Negative changes indicate improvement and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Change in RehaWalk-Recorded Walking Distance Per Session
Walking distance completed during a single RehaWalk session will be expressed in meters. Change will be calculated as the distance in the final session minus the distance in the first session. Positive changes indicate improvement and will be compared between participants with and without ideomotor apraxia.
Measured: Baseline and after the 15th rehabilitation session or at discharge, whichever comes first (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ertan Yılmaz, MD, Principal investigator, Izmir City HospitalAylin Dikici, MD, Study director, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881471
- Sponsor's protocol ID
- 2026/27
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to confidentiality requirements of the institutional ethics committee. De-identified data may be made available by the study director upon reasonable request after publication of the results.