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Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03343132
Enrollment
98
Registered
2017-11-17
Start date
2018-01-01
Completion date
2022-09-02
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Disorder, Sensorimotor, Gait Disorders, Neurologic

Brief 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.

Interventions

BEHAVIORALStandard locomotor therapy

Typical clinical therapy.

Sponsors

Foundation Wings For Life
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in kinematicsBaseline and through study completion, an average of 4 monthsRecording of movement tasks

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026