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Completed

NCT Number: NCT04228224

Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

About this study

Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.

This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • unilateral lower extremity paresis
  • haemorrhagic or ischemic stroke
  • a minimum of six months after the acute infarction/onset of the disease
  • full passive range of motion in lower extremity or at least at neutral position
  • be able to stand freely
  • be able to walk with or without aid for at least 20 meters in less than 2 minutes

Exclusion criteria

  • peripheral nervous system pathology
  • epilepsy
  • weight over 100 kg
  • no cognitive ability to follow the study instructions
  • pregnancy
  • use of implanted devices
  • instable lower extremity joints or fixed contracture

Treatment and study plan

Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)

Device

The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.

Conventional gait rehabilitation

Behavioral

Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.

Primary outcomes

  1. Gait Deviation Index Baseline

    Time frame: Baseline

    Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

  2. Gait Deviation Index Post-Intervention

    Time frame: 12 weeks

    Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

Secondary outcomes

  1. Maximal muscle strength Baseline

    Time frame: Baseline

    Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral hip extension-flexion, and hip adduction-abduction (standing), knee extension-flexion (seated), respectively. Both the affected (AF) and non-affected (NA) leg. A hand-held dynamometer will be used for the assessment.

  2. Maximal muscle strength Post-Intervention

    Time frame: 12 weeks

    Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral hip extension-flexion, and hip adduction-abduction (standing), knee extension-flexion (seated), respectively. Both the affected (AF) and non-affected (NA) leg. A hand-held dynamometer will be used for the assessment.

  3. Distance in 6 Minute Walk Test (6MWT) Baseline

    Time frame: Baseline

    Measure of the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test consist in a evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.

  4. Distance in 6 Minute Walk Test (6MWT) Post-Intervention

    Time frame: 12 weeks

    Measure of the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test consist in a evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.

  5. Muscle tone measured using modified ashworth scale (MAS) Baseline

    Time frame: Baseline

    Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.

  6. Muscle tone measured using modified ashworth scale (MAS) Post-Intervention

    Time frame: 12 weeks

    Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.

  7. Passive range of motion Baseline

    Time frame: Baseline

    Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer

  8. Passive range of motion Post-Intervention

    Time frame: 12 weeks

    Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer

  9. 10 meter walk test Baseline

    Time frame: Baseline

    The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

  10. 10 meter walk test Post-Intervention

    Time frame: 12 weeks

    The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

  11. Timed Up and Go Baseline

    Time frame: Baseline

    Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.

  12. Timed Up and Go Post-Intervention

    Time frame: 12 weeks

    Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.

  13. Berg Balance Scale Baseline

    Time frame: Baseline

    Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.

  14. Berg Balance Scale Post-Intervention

    Time frame: 12 weeks

    Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.

  15. Functional Ambulation Classification (FAC) Baseline

    Time frame: Baseline

    FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.

  16. Functional Ambulation Classification (FAC) Post-Intervention

    Time frame: 12 weeks

    FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.

  17. Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology

    Time frame: 12 weeks

    Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction

  18. Medical Research Council test (MRC) Baseline

    Time frame: Baseline

    Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.

  19. Medical Research Council test (MRC) Post-Intervention

    Time frame: 12 weeks

    Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.

  20. Gait Speed Baseline

    Time frame: Baseline

    Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.

  21. Gait Speed Post-intervention

    Time frame: 12 weeks

    Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.

Sponsors and collaborators

Lead sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2020
Registry last updated
Jul 16, 2020

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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