Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

Gait Disorders, Neurologic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343132
• Other study ID #: 2017-01780
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: September 2, 2022

Study information

• Verified date: August 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Nervous System Diseases
• Spinal Cord Injuries

Intervention

Behavioral:
• Standard locomotor therapy
Typical clinical therapy.

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Foundation Wings For Life

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in kinematics	Recording of movement tasks	Baseline and through study completion, an average of 4 months