Health TrialsbyHealthPanel

Exoskeleton and Spinal Cord Stimulation for SCI

ConditionsSpinal Cord InjuryAmbulation DifficultyMuscle Spasticity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKessler Foundation

About this trial

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

be a non-walker with an SCI greater than 6 years post injury;

have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam;

be between the ages of 18-65 years old;

have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10;

Disqualifiers

have a history of broken or fractured bones.

have a history of bone trauma or bone disease.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Exoskeleton-Assisted Walking

    Device

    Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.

  • Transcutaneous Lumbosacral Stimulation (TLS)

    Device

    EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: EAW + TLSExperimental treatment 2 interventions
Group B: EAW without TLSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change 6-minute walk test (6MWT)

Participants undergoing EAW+TLS intervention will walk significantly further than those receiving EAW alone.

Time frame
Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.
2

Percentage change 10 meter walk test (10MWT)

Participants undergoing EAW+TLS intervention will walk significantly faster than those receiving EAW alone training.

Time frame
Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.

Secondary outcomes

1

Percentage change in scores on Berg Balance scale (BERG)

Participants undergoing EAW+TLS intervention will exhibit significantly greater improvements in standing balance than those receiving EAW alone training.

Time frame
Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.
2

Absolute change in the International Standards Examination

Participants undergoing EAW+TLS intervention will exhibit significantly greater improvements in lower extremity motor scores (LEMS) than those receiving EAW alone training.

Time frame
Baseline and post intervention

Other outcomes

1

percent change in ariel mineral bone density.

Significant ariel bone mineral density

Time frame
Baseline and immediately post intervention.
2

percent change in volume metric and bone mineral density.

Significant ariel of volume metric and bone mineral density.

Time frame
Baseline and immediately post intervention.
3

percent change in bone strength and bone stiffness.

Significant ariel of bone strength and bone stiffness.

Time frame
Baseline and immediately post intervention.

Sponsors and contacts

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

Kessler Foundation

Lead sponsor

Kessler Institute for Rehabilitation

Collaborator

Source ClinicalTrials.gov
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