Recruiting

Observational Study

Sponsor:

University of Houston

Code:

NCT02114450

Conditions

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Robot-assisted training with the H2 lower limb powered exoskeleton

Supervised motor practice

Study Details

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.

Conditions

Stroke

Hemiparesis

Study ID

NCT02114450

Start date

Nov 20, 2015

Status verified date

Oct, 2024

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

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.

Inclusion criteria for healthy, able-bodied participants:

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

Exclusion criteria for healthy, able-bodied participants:

- History of neurological, neuromuscular or physical disability.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

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.

Primary outcome measure

  • Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]
  • Change from baseline in Functional Gait Assessment [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]
  • Change from baseline in Lower limb joint kinematics during walking [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]
  • Change in cortical dynamics measured by Electroencephalography (EEG) [ Time Frame: Each Experimental/Training Session (12 visits) over the 4 week training period ]

Central Contacts and Locations

Central contacts

Jose L Contreras-Vidal, PhD

713-743-4429jlcontreras-vidal@UH.EDU

Locations

University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Jose L Contreras-Vidal, PhD

713-743-4429jlcontreras-vidal@uh.edu

More Information

Sponsor

University of Houston

Last update posted

Oct 30, 2024

Last verified

Oct, 2024

Keywords

  • Stroke
  • Paresis
  • Gait rehabilitation
  • Human-Machine Interaction
  • Wearable Robotic Devices

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2024-10-30.