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Improve Dynamic Lateral Balance of Humans With SCI

ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShirley Ryan AbilityLab

About this trial

This study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. One group will receive pelvis perturbation training paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and one group will receive treadmill training only.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age between 18 and 65 years;

medically stable with medical clearance to participate;

level of the SCI lesion between C4-T10;

passive range of motion of the legs within functional limits of ambulation;

Disqualifiers

the presence of unhealed decubiti, existing infection, severe cardiovascular and pulmonary disease, concomitant central or peripheral neurological injury (e.g. traumatic head injury or peripheral nerve damage in lower limbs);

history of recurrent fractures and/or known orthopedic injury to the lower extremities;

Botox injection within 6 months of starting the study, and current receiving physical therapy treatment;

have metallic implantation in the spinal region underneath where electrodes may be placed.

Trial design

Design model

Parallel

Treatments tested in this trial

  • robotic training

    Device

    robotic training by applying pelvis force perturbation

  • spinal cord electrical stimulation

    Device

    Applying direct current electrical stimulation on spinal cord

  • treadmill

    Device

    conventional treadmill training only

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: robotic training & stimulationExperimental treatment 3 interventions
Group B: robotic training & shamActive comparator 2 interventions
Group C: treadmill onlyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in overground gait speed from baseline

gait speed

Time frame
post 6 weeks of training and 8 weeks after the end of training

Secondary outcomes

1

Changes in balance (BBS score) from baseline

Berg Balance Score

Time frame
post 6 weeks of training and 8 weeks after the end of training
2

Changes in dynamic gait index from baseline

Dynamic Gait Index

Time frame
post 6 weeks of training and 8 weeks after the end of training
3

Changes in 6 minutes walking distance from baseline

Walking distance in 6 minutes

Time frame
post 6 weeks of training and 8 weeks after the end of training

Other outcomes

Sponsors and contacts

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

Shirley Ryan AbilityLab

Lead sponsor

Source ClinicalTrials.gov
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