Spinal Cord InjuriesNCT01105260
Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals
An observational study of Spinal Cord Injuries, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial summary
Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 20 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 2010to Jun 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with acute spinal cord injury (SCI) from trauma, medical or surgical pathology at levels between C7 and L1
Who may be able to join
- Acute spinal cord injury (SCI) from trauma , medical or surgical pathology at levels between C7 and L1.
- Categories A or B as defined by the American Spinal Injury Association (ASIA) Impairment Scale
- Male or female
- 18 to 60 years old.
- No ability to walk independently with or without an assistive device
- 3 to 6 months post-SCI in early phase of rehabilitation in a physical medicine and rehabilitation unit.
- Subject affiliated to a social security regime and registered at the healthcare department
- Written informed consent obtained from each subject
Who cannot join
- Symptomatic syringomyelia that may complicate the evaluation procedures
- Disabled pathology before the SCI
- Cardiopulmonary disease, degenerative disorders, upper limb disorders, bones inury or other significant medical complications that would prohibit or alter compliance with a wheelchair training protocol.
- Psychological incapacity to follow a training protocol during 8 weeks.
- Surgery or intrathecal injection planned.
- Reject to give written informed consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Besançon
Besançon
Centre de Rééducation de la Tour de Gassie
Bruges
Groupe Hospitalier Raymond Poincaré - APHP
Garches
Service MPR des Kermes - Hôpital René Sabran
Giens
Centre mutualiste neurologique Propara
Montpellier
CHU Nantes
Nantes
Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Ploemeur
Centre de Réadaptation fonctionnelle - UGECAM
Strasbourg
About this study
Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).
- Conditions
- Spinal Cord Injuries
- Keywords
- early reconditioning program, spinal cord injury, early rehabilitation, wheelchair
- 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 |
|---|---|---|
| control | group with classical rehabilitation program | |
| training | group with an 8 weeks interval training program on wheelchair independence |
What is being measured
The primary outcome is the main question the study is designed to answer.
wheelchair independence and mobility
adapted 6-minutes walk test (maximal distance ran in 6 minutes with patient's personal wheelchair) crossing a 5% slope functional independence measure (FIM) quality of life
Measured: inclusion and 6 month
Secondary outcomes (2)
Cardiovascular parameters
Maximal exercise test (maximal oxygen uptake, maximal tolerated power (MTP), ventilatory threshold (VS), maximal heart rate, blood pressure, blood lactate) Three exercise tests to exhaustion (work rate fixed at 90, 100 and 110 % MTP, to determine the critical power (power which can be sustained without fatigue)
Measured: inclusion and 6 month
Biomechanic parameters during manuel wheelchair propulsion
Push phases push frequency total cycle time
Measured: inclusion and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2014
- Study completionJun 2015
Why it stopped: Difficulty to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Calmels, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105260
- Sponsor's protocol ID
- 0901040
- Other IDs
- 2009-A00866-51
- Status last verified
- Jul 2015
- First submitted
- 23 Mar 2010
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals
- ClinicalTrials.gov ID
- NCT01105260
- Acronym / sponsor ID
- 0901040
- Conditions
- Spinal Cord Injuries
- Keywords
- early reconditioning program, spinal cord injury, early rehabilitation, wheelchair
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty to include patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Apr 2010 (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.
Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –group with classical rehabilitation program |
| training | – | –group with an 8 weeks interval training program on wheelchair independence |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with acute spinal cord injury (SCI) from trauma, medical or surgical pathology at levels between C7 and L1
Key inclusion criteria (8 listed)
- Acute spinal cord injury (SCI) from trauma , medical or surgical pathology at levels between C7 and L1.
- Categories A or B as defined by the American Spinal Injury Association (ASIA) Impairment Scale
- Male or female
- 18 to 60 years old.
- No ability to walk independently with or without an assistive device
Key exclusion criteria (6 listed)
- Symptomatic syringomyelia that may complicate the evaluation procedures
- Disabled pathology before the SCI
- Cardiopulmonary disease, degenerative disorders, upper limb disorders, bones inury or other significant medical complications that would prohibit or alter compliance with a wheelchair training protocol.
- Psychological incapacity to follow a training protocol during 8 weeks.
- Surgery or intrathecal injection planned.
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
wheelchair independence and mobility
Time frame: inclusion and 6 month
adapted 6-minutes walk test (maximal distance ran in 6 minutes with patient's personal wheelchair) crossing a 5% slope functional independence measure (FIM) quality of life
2 secondary outcomes
Cardiovascular parameters
Time frame: inclusion and 6 month
Biomechanic parameters during manuel wheelchair propulsion
Time frame: inclusion and 6 month
Results and safety
The study was stopped early (reason given: Difficulty to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Paul Calmels, MD principal investigator
CHU de Saint-Etienne
8 sites 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 Injuries, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 was stopped early (reason given: Difficulty to include patients). Results are not available in the source record.
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?
wheelchair independence and mobility (time frame: inclusion and 6 month). 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 28 Jul 2015.