Spinal Cord Injury/DamageNCT02031835
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
A study testing BWSTT (3 days a week for maximum of 20 minutes session) in people with Spinal Cord Injury/Damage, run by University of Ioannina at 1 site in Greece.
Trial summary
The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related… Read more about this study
- Who is it for?
- Ages 8 to 88 years
- Conditions the study is for
- Spinal Cord Injury/Damage
- What is being tested?
- BWSTT (3 days a week for maximum of 20 minutes session)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2012to Mar 2020
- 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 8 to 88 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SCI
- ASIA classification B, C or D
- clinical stable
Who cannot join
- unstable cardiac conditions
- epilepsy
- autonomic dysreflexia
- significant musculoskeletal problems in lower extremities other than SCI
- Parkinson's disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS).
- Conditions
- Spinal Cord Injury/Damage
- Being tested
- BWSTT (3 days a week for maximum of 20 minutes session)
- 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.
BWSTT (3 days a week for maximum of 20 minutes session)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| BWSTT (3 days a week for maximum of 20 minutes session) | Other | BWSTT (20 minutes of treadmill training (velocity (≥0.1km/h) and body weight support (≤40% of patients weight) according to patients capability and comfort Receives: Procedure: BWSTT (3 days a week for maximum of 20 minutes session) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WISCI II
Change of walking independence at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Secondary outcomes (7)
ASIA standard neurological classification for spinal cord injury patients working sheet
Change of neurological impairment status at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Modified Ashworth scale
Change of spasticity of leg muscles at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
WHOQOL-BREF
Change of patients' perspective of life quality at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
10-item Modified Barthel Index
Change of function at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
DXA scan
Change of BMD of hip and spine at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Full Body DXA scan
Change of body tissue consistency at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Hematological analysis
Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks
Measured: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury/DamageStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031835
- Sponsor's protocol ID
- UIoannina612014
- Status last verified
- Nov 2020
- First submitted
- 7 Jan 2014
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT02031835
- Acronym / sponsor ID
- UIoannina612014
- Conditions
- Spinal Cord Injury/Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 9 Jan 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.
The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BWSTT (3 days a week for maximum of 20 minutes session) | Other | Procedure: BWSTT (3 days a week for maximum of 20 minutes session)BWSTT (20 minutes of treadmill training (velocity (≥0.1km/h) and body weight support (≤40% of patients weight) according to patients capability and comfort |
Who may qualify
- Ages
- 8 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- SCI
- ASIA classification B, C or D
- clinical stable
Key exclusion criteria (5 listed)
- unstable cardiac conditions
- epilepsy
- autonomic dysreflexia
- significant musculoskeletal problems in lower extremities other than SCI
- Parkinson's disease
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 |
|---|---|---|
| BWSTT (3 days a week for maximum of 20 minutes session) | Procedure or surgery | BWSTT (3 days a week for maximum of 20 minutes session) |
Primary outcome
WISCI II
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Change of walking independence at six weeks
7 secondary outcomes
ASIA standard neurological classification for spinal cord injury patients working sheet
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Modified Ashworth scale
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
WHOQOL-BREF
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
10-item Modified Barthel Index
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
DXA scan
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Full Body DXA scan
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Hematological analysis
Time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six 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 3 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWSTT (3 days a week for maximum of 20 minutes session) in people with Spinal Cord Injury/Damage, run by University of Ioannina at 1 site in Greece.
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 3 inclusion and 5 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 3 Nov 2020. 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 Greece. 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?
WISCI II (time frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.