Transcutaneous Spinal Cord Stimulation Combined With Robot-assisted Therapy in Incomplete Spinal Cord Injury Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Change in lower limbs muscle strength (LEMS)
Study Overview
Brief Summary
Lumbosacral spinal stimulation activates the neural network involved in the control of locomotion at the spinal level. However, its effects are limited to the production of robust rhythmic patterns of alternating movement, being currently in the absence of therapeutic value. On the other hand, the use of robotic technology for gait rehabilitation has experienced significant growth during the last years and its clinical efficacy is similar to others traditional interventions.
Detailed Description
Spinal cord injury (SCI) often results in complete or partial paralysis below the level of lesion, having a profound physical, psychological and socioeconomic impact on the affected person's life. Between the different approaches for the rehabilitation of SCI, we can find robot therapy. Robot-assisted gait training has emerged as a promising therapy for improving walking ability, balance and motor function in neurological patients. The underlying principle of this therapy is based on the execution of repetitive and task-specific training able to generate appropriate afferent inputs, activating the central pattern generators in the lumbosacral spinal cord. Another novel therapy is the use of transcutaneous spinal cord stimulation (tSCS), applied through self-adhesive electrodes in the skin. tSCS activates similar mechanisms than epidural stimulation and is able to stimulate the spinal locomotor circuits in SCI patients. It allows the activation of rhythmic, flexo-extension movements in the paralyzed lower limbs.
The aim of this study is to analyze the feasibility, safety and efectiveness of a program of 20 sessions of 30 Hz-tSCS applied over T11-12 intervertebral space combined with Lokomat training in patients with incomplete SCI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
For blinding of participants:
The protocol will be the same in the active tSCS and sham tSCS groups. The sham stimulation will consist of the same stimulation parameters used for active tSCS, except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 s and then slowly decreased to zero. The participants will receive the same instructions that given to the active tSCS session.
For blinding of outcomes assessor:
Two blinded assessors will perform the evaluations before, after and a follow-up at 4 weeks post-intervention.
The operator of the Lokomat will be also masked to the group allocation. To ensure this, the same stimulator and electrode location will be used for both groups and the screen of the device will be covered. Only the investigator who applies spinal stimulation will know which group belongs the patient.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •AIS C or D.
- •2-6 months after injury.
- •Neurological level of injury between C4-T
- •Ashworth less or equal
- •Penn less or equal
- •To understand and to sign the informed consent.
Exclusion Criteria
- •Metal implants over T11-T12
- •Electronic device implants.
- •Allergy to the electrode material
- •Pregnancy
- •Concomitant pathologies
- •Pathology or fracture of the lower limbs
- •Musculoskeletal injury in the lower limbs
- •Lower limbs dysmetria
Outcomes
Primary Outcomes
Change in lower limbs muscle strength (LEMS)
Time Frame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Lower limb muscle strength will be measured by Lower Extremity Motor Score (LEMS). The scores vary from 0-5 for each of five key muscles of the right and left lower limbs, with a maximum score of 50 for both lower extremities.
Change in isometric maximal voluntary contraction strength
Time Frame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Isometric Maximal Voluntary Contraction Strength of quadriceps and tibialis anterior will be measured by hand-held dynamometer Micro Fet 2TM (Hoggan Scientific, LLC, Utah, USA) and will be expressed in Kgs.
Secondary Outcomes
- Change in lower limbs spasticity(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Change in daily function(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Change in gait function(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Change in aerobic capacity and endurance(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Change in peak-to-peak amplitude and latency of motor evoked potentials(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Change in balance and fall risk(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Change in walking ability(Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.)
- Blinding assesment(At follow-up at 4 weeks.)