NCT07091045

Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients

Not yet recruiting NA Last updated 29 July 2025

What this trial tests

NA trial testing Robot-Assisted Foot-Ankle Training in Stroke in 30 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
1 August 2026

1 December 2026

Quick facts

Lead sponsor	Medipol University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 August 2025
Primary completion	1 August 2026
Estimated completion	1 December 2026
Sites	2 locations across Turkey (Türkiye)

Drugs / interventions tested

• Robot-Assisted Foot-Ankle Training
• Conventional Foot-Ankle Training

Conditions studied

• Stroke — all drugs for Stroke →
• Robotic Rehabilitation — all drugs for Robotic Rehabilitation →
• Virtual Reality Therapy — all drugs for Virtual Reality Therapy →

Sponsor

Medipol University

Who can join

Adults 45 to 60, any sex, with Stroke or Robotic Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke, one of the central nervous system (CNS) disorders, is a global public health problem due to its high mortality rate and level of physical and mental disability. It is the leading cause of death after heart disease and cancer and one of the most important causes of disability worldwide. After a stroke, motor and sensory disorders, activity and participation limitations and various complications related to these are observed in the lower extremities. As a result of these losses, balance, mobility and gait abnormalities lead to a decrease in quality of life and fall problems.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.