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Exoskeleton + Spinal Cord Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Gail F. Forrest, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a spinal cord injury at a neurological level of injury as determined by study staff between C6-T-10

Be wheelchair reliant 100% of the time

Must not have

Have a history of bone trauma or bone disease

Have a history of broken or fractured bones

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a nerve stimulation device combined with an exoskeleton affects the ability to walk after an injury.

Who is the study for?

This trial is for adults aged 21-58 who are wheelchair reliant due to a spinal cord injury (SCI) that occurred over 6 years ago. Participants must be between 62 and 74 inches tall, have some lower limb movement, and no history of bone fractures or diseases.

What is being tested?

The study is testing if using transcutaneous lumbosacral stimulation (TLS) while walking with an exoskeleton helps improve walking ability in people with SCI compared to just using the exoskeleton alone.

What are the potential side effects?

Potential side effects may include skin irritation from the device, muscle fatigue, discomfort during stimulation, and possible falls or injuries related to use of the exoskeleton.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is between my neck and mid-back.

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I use a wheelchair all the time.

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I am between 21 and 58 years old.

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I have been unable to walk for over 6 years due to a spinal cord injury.

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My leg strength score is 16 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bone disease or injury in the past.

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I have had broken bones in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage change 10 meter walk test (10MWT)

Percentage change 6-minute walk test (6MWT)

Secondary study objectives

Absolute change in the International Standards Examination

Percentage change in scores on Berg Balance scale (BERG)

Other study objectives

percent change in ariel mineral bone density.

percent change in bone strength and bone stiffness.

percent change in volume metric and bone mineral density.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: EAW without TLSExperimental Treatment1 Intervention

EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .

Group II: EAW + TLSExperimental Treatment2 Interventions

The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).

0 / 7Eligibility criteria met