NCT03343132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

4.7 years

First QC Date

October 9, 2017

Last Update Submit

September 4, 2022

Conditions

Gait Disorders, NeurologicGait Disorder, Sensorimotor

Outcome Measures

Primary Outcomes (1)

  • Change in kinematics

    Recording of movement tasks

    Baseline and through study completion, an average of 4 months

Study Arms (3)

Subacute SCI

Behavioral: Standard locomotor therapy

Chronic SCI

Controls

Interventions

Standard locomotor therapyBEHAVIORAL

Typical clinical therapy.

Subacute SCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic; community sample

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Location

Related Publications (2)

  • Zipser-Mohammadzada F, Scheffers MF, Conway BA, Halliday DM, Zipser CM, Curt A, Schubert M. Intramuscular coherence enables robust assessment of modulated supra-spinal input in human gait: an inter-dependence study of visual task and walking speed. Exp Brain Res. 2023 Jun;241(6):1675-1689. doi: 10.1007/s00221-023-06635-4. Epub 2023 May 18.

    PMID: 37199775DERIVED

  • Mohammadzada F, Zipser CM, Easthope CA, Halliday DM, Conway BA, Curt A, Schubert M. Mind your step: Target walking task reveals gait disturbance in individuals with incomplete spinal cord injury. J Neuroeng Rehabil. 2022 Mar 25;19(1):36. doi: 10.1186/s12984-022-01013-7.

    PMID: 35337335DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2017

First Posted

November 17, 2017

Study Start

January 1, 2018

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

September 7, 2022

Record last verified: 2022-08

Locations

CH(1)