NCT02148887

Brief Summary

We aim to investigate the effect of motor skill training of the upper and lower limbs on the function and structure of the CNS as measured by neuroimaging parameters sensitive to changes in tissue volume and density and the properties of myelin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

May 23, 2014

Last Update Submit

July 9, 2018

Conditions

Investigating Spinal Atrophy in Patients With Spinal Injury

Outcome Measures

Primary Outcomes (2)

  • MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex.

    MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)

  • Raw performance data in the upper and lower limb training task, recorded at each training session.

    Training sessions 4x1hour per week for 4 weeks

Secondary Outcomes (2)

  • Overall activity levels as recorded by a worn accelerometer and clinical scoring tests repeated immediately following the first and final training scan sessions (Day 0 and 28) and the 84 day follow-up scan.

    Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84

  • 3D gait analysis will be performed on certain patients and control subjects at the first and final training scan sessions (Day 28) and the 84 day follow-up scan

    3D gait analysis at day 0, 28, 84

Study Arms (5)

SCI patients with upper limb impairment - Upper limb training

SCI patients with lower limb impairment - Lower limb training

Healthy controls - Upper limb training

Healthy controls - Lower limb training

Healthy controls - No intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with spinal injury

You may qualify if:

  • Patients:
  • Injury to the spinal cord which leads to any neurological deficits
  • able to provide Informed consent
  • Controls:
  • \- able to provide informed consent

You may not qualify if:

  • Pregnancy
  • MRI incompatible
  • Neurologic or physiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Location

Study Design

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

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

CH(1)