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

NCT07091045 | Not Yet Recruiting DMC

• 1 other identifier: E-10840098-202.3.02-2627
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.Vibration and sensory localization training applied for correct stepping on the sole of the foot (plantar) and correct pressure distribution,
2. 2.Passive range of motion training supported by virtual reality,
3. 3.Position sense training,
4. 4.Active range of motion training supported by virtual reality and the "Assist-as-needed-AAN" control paradigm,
5. 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.

Conditions

Stroke; Robotic Rehabilitation; Virtual Reality Therapy

Outcome Measures

Primary Outcomes (12)

• Modified Ashworth Scale (Tonus Assessment)

  The Modified Ashworth Scale (MAS) has six options: 0, 1, 1+, 2, 3, and 4. As the score increases, tone increases and the patient's condition worsens. Modified Ashworth Scale (MAS) Scores: 0: No increase in muscle tone. 1: Slight increase in muscle tone; felt as a sudden catch and release with minimal resistance at the end of the range of motion. 1+: Slight increase in muscle tone; felt as a sudden catch followed by minimal resistance in less than half (\<50%) of the remaining range of motion. 2: More pronounced increase in muscle tone; felt throughout most of the range of motion, but the joint can be moved easily. 3: Significant increase in muscle tone; passive movement is difficult. 4: Affected part(s) are rigid in flexion or extension.

  From enrollment to the end of treatment at 18 weeks

• Static balance assessment (Single Leg Stance Test)

  In the one-leg stance test, the patient is asked to stand on one leg without assistance, eyes open. The stopwatch is started the moment the patient's foot leaves contact with the ground. The stopwatch is stopped the moment the patient's foot touches the ground, and the time is recorded. The test will be repeated three times and the average calculated. Increasing single-leg standing time indicates progressive improvement.

  From enrollment to the end of treatment at 18 weeks

• Dynamic Balance Assessment (Timed up and Go Test)

  The TUG test, frequently used in stroke survivors, measures a participant's dynamic balance and walking ability by recording the time it takes to complete a series of tasks, including rising from a chair, walking 3 meters forward, turning 180°, and sitting back down. The test will be repeated three times and averaged. Individuals exceeding the upper age limit are at increased risk of falling. A walking speed greater than the upper limit of the range specified for their age group is associated with impaired performance.

  From enrollment to the end of treatment at 18 weeks

• Assessment of Joint Range of Motion (Electrogoniometer)

  Ankle ROM will be evaluated with an electrogoniometer. Ankle dorsi and plantar flexion ROM will be measured in the supine position. Eversion-inversion ROM will be measured in the prone position. An increase in ankle ROM will be considered positive in terms of progression.

  From enrollment to the end of treatment at 18 weeks

• Assessment of Joint Position Sense (electrogoniometer)

  Joint position sense is assessed using an electrogoniometer, first by passive positioning with eyes open, then by active repositioning with eyes open (passive and active repositioning, respectively). The physiotherapist will slowly and randomly move the ankle to three different dorsiflexion angles (e.g., 9°, 12°, 17°) determined based on the patient's ROM. The therapist will hold the ankle in each position for 5 seconds and ask the patient to memorize the ankle position. After the ankle is passively moved to the starting position, the patient will be asked to bring the ankle to the target point. Three different angles will be tested for each assessment, and the distance differences between the passively moved angles and the patient's moved points will be recorded. The test will be repeated three times and the average will be calculated. Increased ROM at these angles will be considered positive for progression.

  From enrollment to the end of treatment at 18 weeks

• Assessment of Walking Capacity (10 meter walking test)

  During the test, the patient walks at a normal walking speed between two markers 10 meters apart, and the total time elapsed is recorded in m/s. A decrease in walking time over the specified distance is considered positive for progression.

  From enrollment to the end of treatment at 18 weeks

• Assessment of Motor Performance (Fugl-Meyer Lower Extremity Assessment)

  It will be evaluated with the Fugl-Meyer Lower Extremity Assessment (FMA-LE). The FMA-LE examines hip, knee, and ankle movements, and hierarchical recovery is recorded from reflexive movements to synergistic and non-synergistic movements based on the Brunnstrom stage of recovery. The FMA-LE is a reliable parameter in patients with early, subacute, and chronic stroke. Classifications for severity of impairment have been proposed based on FMA Total Motor Scores (out of 100 points): \< 50 = Severe 50-84 = Marked 85-94 = Moderate 95-99 = Mild

  From enrollment to the end of treatment at 18 weeks

• Assessment of Tactile Perception Levels (Semmes Weinstein Monofilament Test)

  The Semmes Weinstein Monofilament Test will be used. The test battery assesses sensory functions from light touch to pressure sensation by touching the subject with monofilaments ranging in thickness from 1.65 to 6.65. Classification for the SWM test: 1.65-2.83 (green): normal sensation 3.22-3.61 (blue): diminished light touch sensation 3.84-4.31 (purple): diminished protective sensation 4.56-6.65 (red): loss of protective sensation 6.65 (no response): deep pressure perception.

  From enrollment to the end of treatment at 18 weeks

• Assessment of Quality of Life (Stroke Specific Quality of Life Scale-SSQOL)

  The Stroke-Specific Quality of Life (SS-QOL) scale is a patient-centered outcome measure intended to assess health-related quality of life (HRQOL) specific to stroke patients. Patients must answer each question on the SS-QOL with reference to the past week. It is a self-report measure containing 49 items across 12 domains: Mobility (6 items), Energy (3 items), Upper extremity function (5 items), Work/productivity (3 items), Mood (5 items), Self-care (5 items), Social roles (5 items), Family roles (3 items), Vision (3 items), Language (5 items), Thinking (3 items), and Personality (3 items). Completing the scale takes approximately 10-15 minutes. Items are rated on a 5-point Likert scale. There are three different response sets. Higher scores indicate better functioning. The SS-QOL provides both domain scores and an overall SS-QOL summary score. Domain scores are unweighted averages of the corresponding items, while the summary score is an unweighted average of all twelve domain score

  From enrollment to the end of treatment at 18 weeks

• Assessment of Satisfaction Level Related to the Robot (Quest Scale-Lıkert Scale-4's)

  Assessment of satisfaction with the robot: This will be assessed using a Quest-Likert scale. A 4-point Likert scale will be used for assessment. It is a survey methodology using four response options. Stroke patients express their level of satisfaction by selecting one of four options: 1 Strongly Disagree, 2 Disagree, 3 Agree, and 4 Strongly Agree. A higher score will be interpreted as increased satisfaction and positive patient progress.

  From enrollment to the end of treatment at 18 weeks

• Dynamic Balance Assessment (MiniBESTest)

  The Mini-BESTest, which has validity and reliability in assessing postural control and balance in individuals after stroke, consists of 14 items, each scored between 0 and 2, with a maximum score of 28. "0" indicates the lowest functional level and "2" indicates the highest functional level.

  From enrollment to the end of treatment at 18 weeks

• Assessment of Walking Capacity (2 minute walking test)

  The individual is encouraged to walk as fast as they can safely walk for 2 minutes without any assistance, and the test is administered between two cones set 15 meters apart. Data will be evaluated based on normative data for men and women, according to age groups. Increasing the distance walked over 2 minutes will be considered progressively more positive.

  From enrollment to the end of treatment at 18 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Other: Robot-Assisted Foot-Ankle Training

Conventional Foot-Ankle Training Protocol (KEG):

ACTIVE COMPARATOR

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: Conventional Foot-Ankle Training

Interventions

Robot-Assisted Foot-Ankle Training OTHER

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

Also known as: Robotic foot-ankle therapy in stroke

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

Conventional Foot-Ankle Training OTHER

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 Protocol (KEG):

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (2)

İstanbul Medipol Üniversitesi

Istanbul, Istanbul, 34815, Turkey (Türkiye)

Location

İstanbul Medipol Üniversitesi

Istanbul, Turkey (Türkiye)

Location

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  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Esra TEKECİ, physiotherapist

CONTACT

+905365870917; esratekeci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (2)