Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients
NCT ID: NCT07091045
Last Updated: 2025-07-29
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-08-01
2026-12-01
Brief Summary
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In recent years, the use of robot-assisted rehabilitation in physiotherapy has increased significantly with the support of engineering studies. Robotic and technology-supported trainings enable rehabilitation to be carried out at high intensity and repetition, treatment to be adapted according to the needs of the patient, patient exercise performance to be objectively monitored continuously, customized treatment protocols to be implemented and patients to be motivated with virtual reality technology.
Platform-based end effector robots used for ankle rehabilitation in the lower extremity after stroke allow active and passive joint range of motion training to be performed. In addition to such motor trainings, adding sensory (vibrotactile) localization and cognitive trainings to the treatment improves sensory-motor-cognitive integration.
In this context, with the proposed robot-assisted structured foot-ankle sensorimotor training protocol:
1. Vibration and sensory localization training applied for correct stepping on the sole of the foot (plantar) and correct pressure distribution,
2. Passive range of motion training supported by virtual reality,
3. Position sense training,
4. Active range of motion training supported by virtual reality and the "Assist-as-needed-AAN" control paradigm,
5. Vibration and sensory localization training applied for correct stepping on the sole of the foot (plantar) and correct pressure distribution, a holistic foot-ankle rehabilitation consisting of 5 stages of sensory-motor-cognitive training will be performed.
The aim of the project is to investigate the effectiveness of our structured training protocol, which includes sensory, motor and cognitive integration for foot-ankle rehabilitation, which we created with a robot-assisted foot-ankle system, in stroke patients. Our project aims to improve the tone, range of motion, joint position sense, walking performance, static and dynamic balance control, tactile perception levels and quality of life of the ankle movement and muscles (dorsiflexor and plantar flexor muscles) that are impaired after stroke. It is also aimed to bring a robot-assisted structured foot-ankle training protocol to the literature.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Robot-Assisted Foot-Ankle Training Protocol (REG):
Stage 1: Vibration Training Applied for Proper Stepping on the Sole of the Foot and Proper Pressure Distribution: The first step of the training will be constant vibration, and the second step will be sensory localization training with vibration.
Stage 2: Passive Joint Range of Motion Training with Virtual Reality: The platform will move the ankle passively (passive stretching).
Stage 3: Joint Position Sense Training: The platform will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the platform initially brought.
Stage 4: Active Joint Range of Motion Training with Virtual Reality: Along with active dorsiflexion, when necessary, assistance will be provided with the Assistance as Needed (AAN) control paradigm, a feature of the robotic device.
Stage 5: It is the same as Stage 1
Robot-Assisted Foot-Ankle Training
Stage 1: Vibration Training Applied for Proper Stepping on the Sole of the Foot and Proper Pressure Distribution: The first step of the training will be constant vibration, and the second step will be sensory localization training with vibration.
Stage 2: Passive Joint Range of Motion Training with Virtual Reality: The platform will move the ankle passively (passive stretching).
Stage 3: Joint Position Sense Training: The platform will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the platform initially brought.
Stage 4: Active Joint Range of Motion Training with Virtual Reality: Along with active dorsiflexion, when necessary, assistance will be provided with the Assistance as Needed (AAN) control paradigm, a feature of the robotic device.
Stage 5: It is the same as Stage 1
Conventional Foot-Ankle Training Protocol (KEG):
Stage 1: Sensory Training to the Sole of the Foot: In the first step of the training, the physiotherapist will manually apply constant pressure with a blunt object, and in the second step, sensory localization training with a blunt object will be performed.
Stage 2: Passive Joint Range of Motion Training:
The ankle will be manually moved passively (passive stretching) by the physiotherapist.
Stage 3: Joint Position Sense Training: The physiotherapist will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the physiotherapist initially brought.
Stage 4: Active Joint Range of Motion Training:
This stage will be performed with manual assistance provided by the physiotherapist when necessary, along with active dorsiflexion.
Stage 5: It is the same as Stage 1
Conventional Foot-Ankle Training
Stage 1: Sensory Training to the Sole of the Foot: In the first step of the training, the physiotherapist will manually apply constant pressure with a blunt object, and in the second step, sensory localization training with a blunt object will be performed. Stage 2: Passive Joint Range of Motion Training: The ankle will be manually moved passively (passive stretching) by the physiotherapist. Stage 3: Joint Position Sense Training: The physiotherapist will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the physiotherapist initially brought. Stage 4: Active Joint Range of Motion Training: This stage will be performed with manual assistance provided by the physiotherapist when necessary, along with active dorsiflexion. Stage 5: It is the same as Stage 1
Interventions
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Robot-Assisted Foot-Ankle Training
Stage 1: Vibration Training Applied for Proper Stepping on the Sole of the Foot and Proper Pressure Distribution: The first step of the training will be constant vibration, and the second step will be sensory localization training with vibration.
Stage 2: Passive Joint Range of Motion Training with Virtual Reality: The platform will move the ankle passively (passive stretching).
Stage 3: Joint Position Sense Training: The platform will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the platform initially brought.
Stage 4: Active Joint Range of Motion Training with Virtual Reality: Along with active dorsiflexion, when necessary, assistance will be provided with the Assistance as Needed (AAN) control paradigm, a feature of the robotic device.
Stage 5: It is the same as Stage 1
Conventional Foot-Ankle Training
Stage 1: Sensory Training to the Sole of the Foot: In the first step of the training, the physiotherapist will manually apply constant pressure with a blunt object, and in the second step, sensory localization training with a blunt object will be performed. Stage 2: Passive Joint Range of Motion Training: The ankle will be manually moved passively (passive stretching) by the physiotherapist. Stage 3: Joint Position Sense Training: The physiotherapist will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the physiotherapist initially brought. Stage 4: Active Joint Range of Motion Training: This stage will be performed with manual assistance provided by the physiotherapist when necessary, along with active dorsiflexion. Stage 5: It is the same as Stage 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to understand and follow study instructions,
* Ability to demonstrate coherent speech and spatial-temporal orientation skills, signed informed consent form,
≤ 2 ankle plantar flexor spasticity according to the Modified Ashworth Scale (MAS),
* Completion of all conventional physical therapy,
* Having had a stroke at least 6 months ago (individuals with chronic stroke),
* Ability to walk at least 10 m with or without any assistive device.
Exclusion Criteria
* Having pathologies affecting walking or balance (orthopedic complications, lower extremity amputation, osteoporosis, etc.),
* Uncontrolled conditions (e.g. diabetes, hypertension, debilitating or immunosuppressive diseases),
* İmpairments affecting participants' ability to understand instructions,
* İnsufficient visual acuity to see a screen,
* Fixed or painful contractures of the paretic ankle.
45 Years
60 Years
ALL
No
Sponsors
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Medipol University
OTHER
Responsible Party
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Esra TEKECİ
Principal Investigator
Locations
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İstanbul Medipol Üniversitesi
Istanbul, Istanbul, Turkey (Türkiye)
İstanbul Medipol Üniversitesi
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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MEDİPOLU İSTANBUL MEDİPOL ÜNİVERSİTESİ
Role: primary
References
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Other Identifiers
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E-10840098-202.3.02-2627
Identifier Type: -
Identifier Source: org_study_id
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