Health TrialsbyHealthPanel

Post Stroke Ambulation Recovery Using Robotic Exoskeletons

ConditionHemiparesis After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorKessler Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stroke survivors 3 - 8 months from a recent stroke.

Age: 50 - 80 years

Unilateral hemiparesis

Medical clearance by the Medical Director

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic Exoskeleton

    Device

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

  • SOC

    Other intervention

    Standard of Care

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Stroke REExperimental treatment 1 intervention
Group B: Stroke SOCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

10MWT (Aim 1)

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

Time frame
Change from Baseline 10MWT at 4 weeks
2

6MWT (Aim 1)

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

Time frame
Change from Baseline 6MWT at 4 weeks
3

TUG (Aim 1)

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

Time frame
Change from Baseline TUG at 4 weeks
4

DGI (Aim 1)

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.

Time frame
Change from Baseline DGI at 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kessler Foundation

Lead sponsor

Source ClinicalTrials.gov
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