Spastic GaitNCT01807247
Short Effects of a Rehabilitation Session on Gait in Patients With CNS
An observational study of Spastic Gait and Fall Due to Failure of Support, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy, 1. muscle strengthening of the lower limbs and 2. effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Gait, Fall Due to Failure of Support, Fatigue
- What is being tested?
- Intensive lower limbs muscles strengthening
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Oct 2014
- 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: The population includes patients with various lesions of central nervous system such as post-stroke patients with hemiparesis, patients with spinal cord injury and patients with mutiple sclerosis.
Who may be able to join
- Male or female adults aged ≥ 18 years receiving a motor rehabilitation in the service
- Hemiplegia after stroke or paraplegia incomplete ASIA C or D or multiple sclerosis (EPSS <5).
- Walking with or without technical assistance
- Patients who received and signed information and informed consent
- Patient who received physiotherapy session for rehabilitation of the lower limbs
- Patients able to perform the entire study
Who cannot join
- Patient with safety measure
- Pregnant women, breastfeeding
- Patient who has received botulinum toxin injection of in the lower limbs between 3 weeks and 2 months prior to inclusion in the study
- Bilateral Brain damage, cerebellar syndrome, apraxia, severe aphasia
- Orthopedic complications preventing walking
- Patients who participated in a clinical study within 3 months prior to inclusion • No affiliation to a social security scheme (beneficiary or assignee)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System
The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,
- muscle strengthening of the lower limbs and
- effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.
- Conditions
- Spastic Gait, Fall Due to Failure of Support, Fatigue
- Being tested
- Intensive lower limbs muscles strengthening
- Keywords
- Strengthening muscle, Central nervous system diseases, Gait
- Medical subject headings
- Gait Disorders, Neurologic, Fatigue, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lower limbs muscles strengtheningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hemiparetic | Intensive lower limbs muscles strengthening Receives: Procedure: Intensive lower limbs muscles strengthening | |
| Spinal cord injury | Intensive lower limbs muscles strengthening Receives: Procedure: Intensive lower limbs muscles strengthening | |
| Multiple sclerosis | Intensive lower limbs muscles strengthening Receives: Procedure: Intensive lower limbs muscles strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional capacity after rehabilitation session using functional tests such as 6 minutes walking test and timed up and go
clinical exam, timed up and go, stair test, 6 minutes walking test
Measured: 30 min
Secondary outcomes (1)
Evaluation of gait pattern and muscle activation patterns during video and EMG analyzes.
EMG analysis of rectus femoris, hamstrings, tibialis anterior and soleus
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic GaitStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Nicolas ROCHE, MDPHD, Principal investigator, Hôpital RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807247
- Sponsor's protocol ID
- 2011-A01487-34
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System
- ClinicalTrials.gov ID
- NCT01807247
- Acronym / sponsor ID
- 2011-A01487-34
- Conditions
- Spastic Gait, Fall Due to Failure of Support, Fatigue
- Keywords
- Strengthening muscle, Central nervous system diseases, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Mar 2013 (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 aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,
- muscle strengthening of the lower limbs and
- effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemiparetic | – | Procedure: Intensive lower limbs muscles strengtheningIntensive lower limbs muscles strengthening |
| Spinal cord injury | – | Procedure: Intensive lower limbs muscles strengtheningIntensive lower limbs muscles strengthening |
| Multiple sclerosis | – | Procedure: Intensive lower limbs muscles strengtheningIntensive lower limbs muscles strengthening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes patients with various lesions of central nervous system such as post-stroke patients with hemiparesis, patients with spinal cord injury and patients with mutiple sclerosis.
Key inclusion criteria (6 listed)
- Male or female adults aged ≥ 18 years receiving a motor rehabilitation in the service
- Hemiplegia after stroke or paraplegia incomplete ASIA C or D or multiple sclerosis (EPSS <5).
- Walking with or without technical assistance
- Patients who received and signed information and informed consent
- Patient who received physiotherapy session for rehabilitation of the lower limbs
Key exclusion criteria (6 listed)
- Patient with safety measure
- Pregnant women, breastfeeding
- Patient who has received botulinum toxin injection of in the lower limbs between 3 weeks and 2 months prior to inclusion in the study
- Bilateral Brain damage, cerebellar syndrome, apraxia, severe aphasia
- Orthopedic complications preventing walking
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 |
|---|---|---|
| Intensive lower limbs muscles strengthening | Procedure or surgery | Hemiparetic, Multiple sclerosis, Spinal cord injury |
Primary outcome
Evaluation of functional capacity after rehabilitation session using functional tests such as 6 minutes walking test and timed up and go
Time frame: 30 min
clinical exam, timed up and go, stair test, 6 minutes walking test
1 secondary outcome
Evaluation of gait pattern and muscle activation patterns during video and EMG analyzes.
Time frame: 1 hour
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 4 Feb 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.
Nicolas ROCHE, MDPHD principal investigator
Hôpital RAYMOND POINCARE
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 Spastic Gait and Fall Due to Failure of Support, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 6 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: finished, as of the sponsor's last update on 4 Feb 2015. 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 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 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?
Evaluation of functional capacity after rehabilitation session using functional tests such as 6 minutes walking test and timed up and go (time frame: 30 min). 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 4 Feb 2015.