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NCT Number: NCT06404268

Facilitating Neuroplastic Changes of Acute Stroke Survivors

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UMROI, Baltimore, Maryland, United States

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About this study

Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
  • Hemiplegia or hemiparesis
  • 0≤Manual Muscle Testing (MMT)<=2
  • Age 30-85
  • Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

Exclusion criteria

  • Medically not stable
  • Associated acute medical illness that interferes with ability to training and exercise
  • No impairment or very mild ankle impairment of ankle
  • Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
  • Cognitive impairment or aphasia with inability to follow instructions
  • Severe pain in legs
  • Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
  • Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

Treatment and study plan

Motor relearning training

Device

Ankle motor control relearning training under real-time feedback

Passive stretching

Device

Passive stretching under intelligent robotic control

Gamed-based active movement training

Device

Active movement training through movement games with robotic assistance

Passive movement

Device

Passive movement in the joint middle range of motion

Active movement training

Device

Active movement training without robotic assistance

Ankle torque and motion measurement

Device

Ankle torque and motion measurement with no real-time feedback

Primary outcomes

  1. Fugl-Meyer Lower Extremity (FMLE)

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]

    The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.

Secondary outcomes

  1. Active range of motion (AROM)

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends

    AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.

  2. Passive Range of Motion (PROM) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends

    Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.

  3. Strength of the ankle flexor-extensor muscle will be measured in Newtons

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends

    Strength of the ankle flexor-extensor muscle will be measured in Newtons

  4. Modified Ashworth Scale (MAS)

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends

    The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.

  5. Berg Balance Scale

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends

    The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

  6. 10-meter Walk Test

    Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends

    The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function.

Study contacts

Contact information is provided by the study sponsor or research team.

Peiwen Fu, BS

CONTACT

[email protected]

410 706-8625

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Official study title

Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 8, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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