NCT02098122

Brief Summary

Functional recovery following SCI in adults is limited. Improvements in the quality of life of affected persons are associated with the recovery of functions that allow independent living, for example use of the arms and hands. Rehabilitative training has been shown to aid upper limb recovery. However, there are likely vast differences in the amount of time individuals spend actively training (during rehabilitation sessions in the clinic) and what they do in their non-training time (during daily life). The activity, or lack of, during the non-training period could interfere (positively or negatively), with the specific training in the rehabilitation session. However, there is little information available about this. Inertial measurement units are increasingly being used in human movement and rehabilitation research. The use of such technology is a promising approach to rapidly and discreetly collect objective movement information. The investigators plan to introduce a novel, long-term, activity sensor into clinical SCI rehabilitation. The investigators use this sensor to precisely measure movement of the upper limb over extended periods of time. Upper limb activity recordings from these sensors allow us to detail the amount and duration of activity during specific periods of upper limb rehabilitation and recovery. The investigators aim is to measure upper limb activity. The investigators aim to track changes in the activity of the upper limb during recovery and rehabilitation in patients with cervical SCI as well as collect reference values of upper limb activity in chronic sufferers. The recordings from this activity sensor will provide a more detailed understanding of how everyday upper limb activity contributes to functional recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

6 years

First QC Date

March 13, 2014

Last Update Submit

June 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of physical activity levels

    Changes of activity levels will be assessed by calculating activity counts from the accelerometer data.

    Cross-sectional and longitudinal (2weeks, 1month, 3months, 6months, 12months)

Study Arms (2)

Tetraplegia

Paraplegia

Eligibility Criteria

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

Spinal Cord Injured Subjects

You may qualify if:

  • Tetraplegic and paraplegic subjects.
  • Males and females aged 18 or older.
  • Acute (defined here as \<90 days after admission of SCI) for the longitudinal follow-up study, as well as chronic (defined here as \>90 days after admission of SCI) for the cross-sectional study, all levels of injury, complete and incomplete, traumatic and non-traumatic injuries.
  • Good enough cognitive ability to be able to follow simple verbal instructions.
  • Signed informed consent before study onset.

You may not qualify if:

  • A neurological disease other than SCI, which is expected to affect the upper limb function, i.e. plexus paresis.
  • An orthopaedic or rheumatologic disease, e.g. osteoarthritis, which is expected to affect the upper limb function.
  • Pre-morbid on-going major depression or psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8008, Switzerland

Location

Related Publications (4)

  • Brogioli M, Schneider S, Popp WL, Albisser U, Brust AK, Velstra IM, Gassert R, Curt A, Starkey ML. Monitoring Upper Limb Recovery after Cervical Spinal Cord Injury: Insights beyond Assessment Scores. Front Neurol. 2016 Aug 31;7:142. doi: 10.3389/fneur.2016.00142. eCollection 2016.

    PMID: 27630612BACKGROUND
  • Brogioli M, Popp WL, Schneider S, Albisser U, Brust AK, Frotzler A, Gassert R, Curt A, Starkey ML. Multi-Day Recordings of Wearable Sensors Are Valid and Sensitive Measures of Function and Independence in Human Spinal Cord Injury. J Neurotrauma. 2017 Mar 15;34(6):1141-1148. doi: 10.1089/neu.2016.4583. Epub 2016 Oct 12.

    PMID: 27533063BACKGROUND
  • Brogioli M, Popp WL, Albisser U, Brust AK, Frotzler A, Gassert R, Curt A, Starkey ML. Novel Sensor Technology To Assess Independence and Limb-Use Laterality in Cervical Spinal Cord Injury. J Neurotrauma. 2016 Nov 1;33(21):1950-1957. doi: 10.1089/neu.2015.4362. Epub 2016 May 16.

    PMID: 27025797BACKGROUND
  • Popp WL, Brogioli M, Leuenberger K, Albisser U, Frotzler A, Curt A, Gassert R, Starkey ML. A novel algorithm for detecting active propulsion in wheelchair users following spinal cord injury. Med Eng Phys. 2016 Mar;38(3):267-74. doi: 10.1016/j.medengphy.2015.12.011. Epub 2016 Feb 8.

    PMID: 26868046BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Armin Curt, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 27, 2014

Study Start

March 1, 2013

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations