Human-Machine System for the H2 Lower Limb Exoskeleton

NCT ID: NCT02114450

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-20
• Study Completion Date: 2029-12-31

Brief Summary

This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.

Detailed Description

Stroke is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Gait impairment is a large contributor to long-term disability and ambulatory function in daily living. Many patients, however, lose the ability to walk independently, and furthermore, a large proportion does not regain their normal walking speeds following a stroke. In this context, newer robotic-aided therapeutic tools such as "wearable" lower-limb robotic exoskeletons have been developed, which allow for the user to be augmented by mechanically actuated lower limb joints that can either completely or partially assist movements of the lower limb segments depending on the patient needs.

The H2 exoskeleton (developed by Technaid S.L., Spain) is an example of one such system that has hip, knee and ankle joints actuated for both lower limbs. These devices are very new, and therefore, systematic investigations of therapeutic benefits of these devices are lacking in the field. Further, the nature of plasticity in the brain triggered by wearing and training such exoskeletons is unknown. In this exploratory research study, the investigators aim to compare robotic-assisted rehabilitation using the H2 exoskeleton with supervised motor practice particularly in terms of functional recovery. Additionally, this study will also examine brain plasticity associated with robotic-assisted training using non-invasive scalp electroencephalography (EEG) and changes in lower limb joint kinematics during robotic-assisted training. Taken together, the findings from this research will be used to understand human-robot interaction and to design smart powered orthotic devices that can be controlled directly by brain activity and assist those that have lost all or part of their walking abilities due to neurological disease or injury. Moreover, this study will systematically track neuroplasticity associated with functional recovery after stroke, which will help determine optimal windows for treatment that would maximize therapeutic benefit. Lastly, it will also help characterize markers of learning to use these new devices, which will be important in the clinical setting for modifying and adapting rehabilitation protocols to suit changing needs of the patient (user).

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Robot-assisted Rehabilitation

Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.

Group Type: EXPERIMENTAL

Robot-assisted training with the H2 lower limb powered exoskeleton

Intervention Type: BEHAVIORAL

The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.

Supervised motor practice

Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.

Group Type: ACTIVE_COMPARATOR

Supervised motor practice

Intervention Type: BEHAVIORAL

Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.

Interventions

Robot-assisted training with the H2 lower limb powered exoskeleton

The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.

Intervention Type: BEHAVIORAL

Supervised motor practice

Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
• Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score > 24 points, out of a total 30 indicating normal cognitive ability);
• Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
• Modified Ashworth Scale of Spasticity score <= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
• Have no skin integrity issues;
• Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);
• Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.

• Able to understand and sign the consent form
• Age 18-75 years

Exclusion Criteria

• Severe cognitive and/or visual deficit;
• Hemineglect (determined based on medical record or initial clinical assessment);
• Severe sensory deficit;
• Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
• Skin lesions that may hinder or prevent the application of exoskeleton;
• Uncontrolled angina;
• Severe chronic obstructive pulmonary disease;
• Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.

• History of neurological, neuromuscular or physical disability.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

TIRR Memorial Hermann

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Jose L.Contreras-Vidal, Ph.D.

Hugh Roy and Lillie Cranz Cullen University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose L Contreras-Vidal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Gerard E Francisco, MD

Role: PRINCIPAL_INVESTIGATOR

TIRR Memorial Hermann Hospital

Jose L Pons, PhD

Role: PRINCIPAL_INVESTIGATOR

Spanish Research Council

Locations

TIRR Memorial Hermann Hospital

Houston, Texas, United States

Site Status: NOT_YET_RECRUITING

University of Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jose L Contreras-Vidal, PhD

Role: CONTACT

jlcontreras-vidal@UH.EDU

713-743-4429

Facility Contacts

Gerard E Francisco, MD

Role: primary

gerard.e.francisco@uth.tmc.edu

713-797-5244

Shuo-Hsiu Chang, PT, PhD

Role: backup

Shuo-Hsiu.Chang@uth.tmc.edu

713-799-7016

Gerard E Francisco, MD

Role: backup

Shuo-Hsiu Chang, PT, PhD

Role: backup

Jose L Contreras-Vidal, PhD

Role: primary

jlcontreras-vidal@uh.edu

713-743-4429

Jose L Contreras-Vidal, PhD

Role: backup

References

Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.

Reference Type: BACKGROUND

PMID: 26076696 (View on PubMed)

Contreras-Vidal JL, Bortole M, Zhu F, Nathan K, Venkatakrishnan A, Francisco GE, Soto R, Pons JL. Neural Decoding of Robot-Assisted Gait During Rehabilitation After Stroke. Am J Phys Med Rehabil. 2018 Aug;97(8):541-550. doi: 10.1097/PHM.0000000000000914.

Reference Type: BACKGROUND

PMID: 29481376 (View on PubMed)

M. Bortole and J.L. Pons, "Development of a Exoskeleton for Lower Limb Rehabilitation," in Converging Clinical and Engineering Research on Neurorehabilitation Biosystems & Biorobotics vol. 1, no. 14, Berlin, Heidelberg: Springer Berlin Heidelberg, 2013, pp. 85-90

Reference Type: BACKGROUND

Related Links

http://www.facebook.com/UHBMIST

University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)

https://med.uth.edu/pmr/research/center-for-wearable-exoskeletons/

The UTHealth Center for Wearable Exoskeletons at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)

Other Identifiers

HSC-MS-14-0129

Identifier Type: OTHER

Identifier Source: secondary_id

14107

Identifier Type: -

Identifier Source: org_study_id