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NCT Number: NCT06736171

Post Stroke Ambulation Recovery Using Robotic Exoskeletons

The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.

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Key information

Conditions

Hemiparesis After Stroke

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location status: Recruiting

Location contact

Karen J Nolan, PhD

PRINCIPAL_INVESTIGATOR

Kiran K Karunakaran, PhD

PRINCIPAL_INVESTIGATOR

Sharon Franco

CONTACT

[email protected]

973-324-3521

About this study

This study will systematically compare various commercially available REs and aid in identifying the appropriate devices for gait training prescription in individuals post-stroke based on their deficits. The objective of this study is to evaluate and compare the four groups (3 REs and standard of care treatment) using biomechanical, functional and community participation & quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stroke survivors 3 - 8 months from a recent stroke.
  • Age: 50 - 80 years
  • Unilateral hemiparesis
  • Medical clearance by the Medical Director
  • Be able to physically fit into the exoskeleton device: Height between 60" and 76" and weight below 220 lbs
  • Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation (e.g. can follow directions).
  • Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback.
  • Have a joint range of motion within normal functional limits for ambulation.
  • Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE.
  • No history of injury or pathology to the unaffected limb.
  • Have an appropriate walking speed as determined by the study staff.

Exclusion criteria

  • Any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
  • Skin issues that would prevent wearing the device.
  • Pre-existing condition that caused exercise intolerance (documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure).
  • Hospitalization for heart attack, heart surgery, or acute heart failure within 3 months of enrollment in the study.
  • Uncontrolled seizure disorder, spasticity, or joint contracture that would interfere with walking.
  • Neuromuscular, neurological, or orthopedic pathologies that interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs.

Treatment and study plan

Robotic Exoskeleton

Device

EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA

SOC

Other

Standard of Care

Primary outcomes

  1. 10MWT (Aim 1)

    Time frame: Change from Baseline 10MWT at 4 weeks

    10 meter walk test to evaluate walking speed after stroke and in response to the intervention.

  2. 6MWT (Aim 1)

    Time frame: Change from Baseline 6MWT at 4 weeks

    6 minute walking test to evaluate endurance after stroke and in response to the intervention

  3. TUG (Aim 1)

    Time frame: Change from Baseline TUG at 4 weeks

    Timed up and go (TUG) test to measure functional balance and walking ability after stroke and in response to the intervention.

  4. DGI (Aim 1)

    Time frame: Change from Baseline DGI at 4 weeks

    Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after stroke and in response to the intervention.

  5. Berg Balance Scale (Aim 1)

    Time frame: Change from Baseline Berg at 4 weeks

    Measure to assess static and dynamic balance and fall risk after stroke and in response to the intervention.

  6. Joint Range of Motion (kinematics) (Aim 2)

    Time frame: Change from Baseline at 4 weeks

    Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes.

  7. Temporospatial Loading (Aim 2)

    Time frame: Change from Baseline at 4 weeks

    Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and insoles.

  8. Balance (Aim 2)

    Time frame: Change from Baseline at 4 weeks

    Static and dynamic balance in standing and seated positions after stroke and in response to the intervention (using Hunova (Movendo Inc, Genova, Italy) plaform).

  9. Survey for Community Participation (Aim 3)

    Time frame: Change from Baseline at 4 weeks

    The Community Participation Indicators (CPI) is a self-reported 48 item objective measure survey.

  10. Survey for Quality of Life (Aim 3)

    Time frame: Change from Baseline at 4 weeks

    The SS-QOL survey assesses health-related quality of life (QOL) specific to stroke survivors with 49 items across 12 domains.

Study contacts

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

Kathleen Goworek

CONTACT

[email protected]

973-324-3560

Sharon Franco

CONTACT

[email protected]

973-324-3521

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke

Acronym: RERC

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Dec 16, 2024
Registry last updated
Sep 2, 2025

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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