Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury
Switzerland98 participantsStarted 2018-01-01
Plain-language summary
Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. The specific assessments will require the participant to acitvely modulate their gait pattern to fullfill specific task constraints. Their performance will be assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the adaptive capacity that the patient retains. Sensitivity and specificity of these markers will be determined. With more sensitive descriptors of gait function and quality, locomotor rehabilitation for SCI can be better designed and smaller effects can be accurately measured.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Healthy controls
* Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
* Age: 18 years and older
* Able to stand without physical assistance and handrails for more than 120s
* preserved segmental and cutaneo-muscular reflexes in the lower limbs
* Bodyweight over 20 kg and under 120 kg
* Mini-Mental state examination score 26 (test only performed if cognitive deficits are suspected)
Exclusion Criteria:
* Current orthopedic problems
* Neurological impairment other than SCI
* Premorbid major depression or psychosis
* Metal implants in the cervical skull
* History of significant autonomic dysreflexia with treatment
* Dermatological issues (e.g. decubitus) at the harness attachment site (back, abdomen, upper legs)
* Malignant diseases
* Heart insufficiency NYHA III-IV
* Potential pregnancy
* Unlikely to complete the intervention or return for follow-up
* Participation in another training study
* Contraindications for training using the GRAIL (according the manual)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in kinematics
Timeframe: Baseline and through study completion, an average of 4 months