Spinal Cord InjuryNCT02703883
Body Weight Support in Spinal Cord Injury
A study testing BWST in people with Spinal Cord Injury, run by University of Chile at 1 site in Chile.
Trial summary
The purpose of this study was to evaluate the effectiveness of body weight-supported treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord injury (SCI) in chronic stage Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- BWST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChile
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI with more than twelve months of evolution.
- ASIA C and D
Who cannot join
- Patients with tracheostomy
- Patients with severe respiratory, cognitive and cardiovascular comorbidities
- Patients with peripheral nerve injury in lower limbs
- Patients with traumatic head injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors
The purpose of this study was to evaluate the effectiveness of body weight-supported treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord injury (SCI) in chronic stage
Read the detailed description
The individuals who participated in this study were subjects with SCI with more than twelve months of evolution. All were classified as incomplete injury class C or D according to the American Spinal Injury Association (ASIA). Each received training on a BWST for six weeks. Two measures of stance balance were performed during the training protocol. The first measure was made before entering the training protocol; the final measure was implemented once the gait training on BWST protocol was completed. For instrumented stance balance testing, small wireless inertial motion sensors (OPAL sensors, APDM Inc., Portland, OR) were placed on the subjects' waist. Subjects performed instrumented stance with their eyes opened (iSway). Outcome measures were recorded and automatically generated using Mobility Lab software (APDM Inc., Portland, OR). Measures included the root mean square of sway and jerk (normalized to the range of acceleration amplitude).
- Conditions
- Spinal Cord Injury
- Being tested
- BWST
- 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.
BWSTDevice
BWST (six weeks, 3 times/week)
| Study group | Role | What they receive |
|---|---|---|
| Body Weight Support | Experimental | Treatment protocol consisted of 18 training sessions on the BWST, three times a week, every session included three sets of six minutes of locomotion with rest intervals of 2 min of rest. Receives: Device: BWST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass)
The jerk is measure with a instrumented stance testing. For this test, we use small wireless inertial sensors (OPAL sensor, APDM, Inc. Portland, OR). This outcome is recorded automatically generated using Mobility Lab Software (APDM Inc., Portland, OR).
Measured: 6 weeks
Secondary outcomes (1)
Walking Index for Spinal Cord Injury (WISCI) scale
The WISCI is a walking scale, that measures the independence of walking based on the use of devices.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJul 2012
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Torres, University of Chile
- Investigators
- Felipe Covarrubias, Principal investigator, Clinica Los Coihues
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703883
- Sponsor's protocol ID
- CLC-1
- Status last verified
- Mar 2016
- First submitted
- 29 Feb 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Covarrubias-Escudero F, Rivera-Lillo G, Torres-Castro R, Varas-Diaz G. Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. J Spinal Cord Med. 2019 Jan;42(1):57-64. doi: 10.1080/10790268.2017.1389676. Epub 2017 Oct 23.
PubMed 29058553
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors
- ClinicalTrials.gov ID
- NCT02703883
- Acronym / sponsor ID
- CLC-1
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Mar 2016 (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.
The purpose of this study was to evaluate the effectiveness of body weight-supported treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord injury (SCI) in chronic stage
Detailed description
The individuals who participated in this study were subjects with SCI with more than twelve months of evolution. All were classified as incomplete injury class C or D according to the American Spinal Injury Association (ASIA). Each received training on a BWST for six weeks. Two measures of stance balance were performed during the training protocol. The first measure was made before entering the training protocol; the final measure was implemented once the gait training on BWST protocol was completed. For instrumented stance balance testing, small wireless inertial motion sensors (OPAL sensors, APDM Inc., Portland, OR) were placed on the subjects' waist. Subjects performed instrumented stance with their eyes opened (iSway). Outcome measures were recorded and automatically generated using Mobility Lab software (APDM Inc., Portland, OR). Measures included the root mean square of sway and jerk (normalized to the range of acceleration amplitude).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Weight Support | Experimental | Device: BWSTTreatment protocol consisted of 18 training sessions on the BWST, three times a week, every session included three sets of six minutes of locomotion with rest intervals of 2 min of rest. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- SCI with more than twelve months of evolution.
- ASIA C and D
Key exclusion criteria (4 listed)
- Patients with tracheostomy
- Patients with severe respiratory, cognitive and cardiovascular comorbidities
- Patients with peripheral nerve injury in lower limbs
- Patients with traumatic head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BWSTBWST (six weeks, 3 times/week) | Device | Body Weight Support |
Primary outcome
Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass)
Time frame: 6 weeks
The jerk is measure with a instrumented stance testing. For this test, we use small wireless inertial sensors (OPAL sensor, APDM, Inc. Portland, OR). This outcome is recorded automatically generated using Mobility Lab Software (APDM Inc., Portland, OR).
1 secondary outcome
Walking Index for Spinal Cord Injury (WISCI) scale
Time frame: 6 weeks
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 9 Mar 2016.
- Derived from this study: PubMed 29058553Covarrubias-Escudero F, Rivera-Lillo G, Torres-Castro R, Varas-Diaz G. Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. J Spinal Cord Med. 2019 Jan;42(1):57-64. doi: 10.1080/10790268.2017.1389676. Epub 2017 Oct 23.
- Individual participant dataSharing planned: No
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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.
Felipe Covarrubias principal investigator
Clinica Los Coihues
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWST in people with Spinal Cord Injury, run by University of Chile at 1 site in Chile.
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 2 inclusion and 4 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 9 Mar 2016. 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 Chile. 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?
Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass) (time frame: 6 weeks). 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 NCT02703883, which also lists 1 linked publication.
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 9 Mar 2016.