Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

Completed

• Conditions: Gait Disorders, Neurologic; Gait Disorder, Sensorimotor
• Interventions: Behavioral: Standard locomotor therapy

• Registration Number: NCT03343132
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Study Start: 2018-01-01
• Status Verified: 2022-08
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subacute SCI	Standard locomotor therapy	-

Primary Outcome Measures

Name	Time	Method
Change in kinematics	Baseline and through study completion, an average of 4 months	Recording of movement tasks

Trial Locations

Locations (1)

Universitätsklinik Balgrist; 🇨🇭 Zürich, Switzerland