Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

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.

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Key information

Conditions

Gait Disorders, Neurologic Gait Disorder, Sensorimotor Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard locomotor therapy

Behavioral

Typical clinical therapy.

Primary outcomes

Change in kinematics

Time frame: Baseline and through study completion, an average of 4 months

Recording of movement tasks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

Foundation Wings For Life

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Nov 17, 2017
Registry last updated: Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed