Exoskeleton and Spinal Cord Stimulation for SCI

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT03096197
Status
Recruiting
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Conditions

  • Ambulation Difficulty
  • Muscle Spasticity
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 30, 2017
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: EAW + TLS
    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).
  • Experimental: EAW without TLS
    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 .

Primary Outcome Measure

Percentage change 6-minute walk test (6MWT) [ 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Gail F Forrest, Ph.D
[email protected]
973 324 3518

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Kessler Foundation· West Orange, NJ

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