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

Medipol University

Status: Not yet enrolling

Conditions: Virtual Reality Therapy; Stroke; Robotic Rehabilitation

Treatments: Other: Robot-Assisted Foot-Ankle Training; Other: Conventional Foot-Ankle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07091045

E-10840098-202.3.02-2627

Details and patient eligibility

About

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.

Full description

Power analysis using G-Power version 3.1 yielded 90% power, a d=1.135 effect size, and a total sample size of n=30, with each group consisting of 15 observations. Participants will be randomly assigned to either the Robotic-Assisted Foot-Ankle Training Protocol (REG) or the Conventional Foot-Ankle Training Protocol (CEG). One group will receive training with the robotic foot-ankle platform, while the other group will receive conventional training (manual training with a physiotherapist). Exercise programs will last 6 weeks, 3 days a week, for 40-45 minutes. Progression will be provided using the AAN control paradigm on the robot, and by the physiotherapist in the conventional training.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 40 and 65 years,

• 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

• Cognitive impairment (Mini-Mental State Examination score ≤ 24),
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Robot-Assisted Foot-Ankle Training Protocol (REG):

Experimental group

Description:

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

Treatment:

Other: Robot-Assisted Foot-Ankle Training

Conventional Foot-Ankle Training Protocol (KEG):

Active Comparator group

Description:

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

Treatment:

Other: Conventional Foot-Ankle Training