Spinal Cord InjuryNCT02098122
Upper Limb Activity in Human SCI Rehabilitation
An observational study of Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 182 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to 13 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal Cord Injured Subjects
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tetraplegia | Not described | |
| Paraplegia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of physical activity levels
Changes of activity levels will be assessed by calculating activity counts from the accelerometer data.
Measured: Cross-sectional and longitudinal (2weeks, 1month, 3months, 6months, 12months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2013
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life, IRP International Foundation for Research in Paraplegia
- Responsible party
- Sponsor
- Investigators
- Armin Curt, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098122
- Sponsor's protocol ID
- KEK-ZH-2013-0202/PB2016-00338
- Status last verified
- Jun 2019
- First submitted
- 13 Mar 2014
- Last updated
- 6 Jun 2019
- Results posted
- No
Publications
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.
PubMed 27630612Brogioli 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.
PubMed 27533063Brogioli 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.
PubMed 27025797Popp 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.
PubMed 26868046
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Activity in Human SCI Rehabilitation
- ClinicalTrials.gov ID
- NCT02098122
- Acronym / sponsor ID
- KEK-ZH-2013-0202/PB2016-00338
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Foundation Wings For Life, IRP International Foundation for Research in Paraplegia
- Study start
- Mar 2013 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetraplegia | – | – |
| Paraplegia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal Cord Injured Subjects
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Background: PubMed 27630612Brogioli 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.
- Background: PubMed 27533063Brogioli 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.
- Background: PubMed 27025797Brogioli 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.
- Background: PubMed 26868046Popp 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.
Related trials for Spinal Cord Injury
Recruiting
Efficacy of rTMS Treatment After Spinal Cord Injury
Spinal Cord Injuries, Myelopathy
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Active, not recruitingObservational study
Recovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Curt, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physical activity levels (time frame: Cross-sectional and longitudinal (2weeks, 1month, 3months, 6months, 12months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098122, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.