Upper Limb Activity in Human SCI Rehabilitation

June 5, 2019 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Spinal Cord Injured Subjects

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Paraplegia
Tetraplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of physical activity levels
Time Frame: Cross-sectional and longitudinal (2weeks, 1month, 3months, 6months, 12months)
Changes of activity levels will be assessed by calculating activity counts from the accelerometer data.
Cross-sectional and longitudinal (2weeks, 1month, 3months, 6months, 12months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Foundation Wings For Life
IRP International Foundation for Research in Paraplegia

Investigators

  • Principal Investigator: Armin Curt, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

March 13, 2019

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-2013-0202/PB2016-00338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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