Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-09-02

Brief Summary

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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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Detailed Description

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Conditions

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Gait Disorders, Neurologic Gait Disorder, Sensorimotor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Subacute SCI

Standard locomotor therapy

Intervention Type BEHAVIORAL

Typical clinical therapy.

Chronic SCI

No interventions assigned to this group

Controls

No interventions assigned to this group

Interventions

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Standard locomotor therapy

Typical clinical therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes