Spinal Cord InjuriesNCT05196204
Trunk Task-oriented Training Combined With Functional Electrical Stimulation in Spinal Cord Injured Individuals
A study testing Trunk-oriented task training combined with functional electrical stimulation and Trunk-oriented task training alone in people with Spinal Cord Injuries, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 2 sites in Canada.
Trial summary
The objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (FES/T-TOT) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following FES/T-TOT in individuals… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Trunk-oriented task training combined with functional electrical stimulation and Trunk-oriented task training alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 11 May 2021to Oct 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Level of spinal cord lesion between C6/C7 and T10
- At least, 6 months post-injury
- Be considered as AIS A, B, C or D
- Be able to sit without support for 15 seconds
- Be able to provide informed consent in English or in French
Who cannot join
- To have cognitive deficits
- To wear a corset
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
- FOR CONTROL PARTICIPANTS
Show all 9Show fewer
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Neuro-Concept Inc
Montreal, Quebec
Charlotte Pion, PhD, Kin, 438-490-8512, charlotte.pion@umontreal.ca
- Enrolling by invitation
Neuromobility lab
Montreal, Quebec
About this study
Official title: Trunk Task-oriented Training Combined With Functional Electrical Stimulation to Improve Functional Independence, Postural Control and Neuroplasticity in Spinal Cord Injured Individuals
The objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (FES/T-TOT) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following FES/T-TOT in individuals with spinal cord injury.
Read the detailed description
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 3 weeks prior to training
- Assessment 1 week prior to training
- Training over 12 weeks
- Assessment 1 week after training
- Assessment 1 month after training (follow-up)
Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. The assessment will consist of:
- Session 1 (at Neuro-Concept clinic) will include presentation of the study and the obtention of written consent, clinical (modified Reaching test and muscle strength), quality of life and functional independence assessments.
- Session 2 (at IURDPM in Dr. Barthélemy's laboratory) will include postural control, corticospinal and cortical assessments.
After the initial assessment, the participants with spinal cord injury will realize 36 sessions of trunk task-oriented training alone or combined with function electrical stimulation (3 times a week for 12 weeks).
- Conditions
- Spinal Cord Injuries
- Being tested
- Trunk-oriented task training combined with functional electrical stimulation, Trunk-oriented task training alone
- Keywords
- Trunk task-oriented training, Corticospinal tract, Functional electrical stimulation, Functional independence, Trunk motor control
- 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.
Trunk-oriented task training combined with functional electrical stimulationOther
Training will consist to perform one hour of trunk task-oriented training combined with functional electrical stimulation (FES/T-TOT) specific for muscle strength and motor control. All training will be done seated without support with knees and hips flexed to 90 degrees. FES will be combined with functional and non-functional tasks to work functionality and muscle strengthening. Each training session will consist on the fulfilment of two functional tasks (as reaching) and two non-functional tasks (as push-up movement) from a battery of postural control exercises.
Trunk-oriented task training aloneOther
The SCI participants who will perform T-TOT training alone will have to perform the same exercises as explained in the previous section (two functional tasks and two non-functional tasks) but they will not receive any functional electrical stimulation.
Training will consist to perform one hour of trunk task-oriented training (T-TOT) specific for muscle strength and motor control. All training will be done seated without support with knees and hips flexed to 90 degrees. Each training session will consist on the fulfilment of two functional tasks (as reaching) and two non-functional tasks (as push-up movement) from a battery of postural control exercises.
| Study group | Role | What they receive |
|---|---|---|
| Trunk-oriented task combined with functional electrical stimulation training group | Experimental | This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training combined with functional electrical stimulation. Receives: Other: Trunk-oriented task training combined with functional electrical stimulation |
| Trunk-oriented task training group | Active comparator | This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training. Receives: Other: Trunk-oriented task training alone |
| Control group | No intervention | Healthy participants will be recruited based on the age and sex of the participants with spinal cord injury to realize clinical, biomechanical and cortical evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Function in Sitting Test
This test evaluates the sitting balance via 14 everyday functional activities rated from 0 to 4 according to the reactions of the participants.
Measured: Before and after the 12-week trainings and 1-month follow-up
Change in modified Functional Reach Test
This test evaluates the ability for each participant to realize a lateral and anterior trunk flexion in order to observe the maximum distance reached.
Measured: Before and after the 12-week trainings and every 4-weeks during the training period
Secondary outcomes (4)
Change in EMG activation pattern of electromyographic activity of muscles in the trunk
during reaching and pointing tasks
Measured: Before and after the 12-week trainings and 1-month follow-up
Change in the center of pressure excursion
during reaching and pointing tasks
Measured: Before and after the 12-week trainings and 1-month follow-up
Modification of the excitability of the reticulospinal pathway using the acoustic startle response
A tone will be triggered just before the reaching movement. The EMG responses of trunk muscles will be analyzed.
Measured: Before and after the 12-week trainings and 1-month follow-up
Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation
Vestibular responses induced by GVS will be identified in the trunk muscles
Measured: Before and after the 12-week trainings and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start11 May 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, Neuro-Concept Inc.
- Responsible party
- Principal investigator, Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196204
- Sponsor's protocol ID
- CRIR-1497-1020
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Task-oriented Training Combined With Functional Electrical Stimulation to Improve Functional Independence, Postural Control and Neuroplasticity in Spinal Cord Injured Individuals
- ClinicalTrials.gov ID
- NCT05196204
- Acronym / sponsor ID
- CRIR-1497-1020
- Conditions
- Spinal Cord Injuries
- Keywords
- Trunk task-oriented training, Corticospinal tract, Functional electrical stimulation, Functional independence, Trunk motor control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Collaborators
- Mitacs, Neuro-Concept Inc.
- Study start
- 11 May 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- 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 objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (FES/T-TOT) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following FES/T-TOT in individuals with spinal cord injury.
Detailed description
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 3 weeks prior to training
- Assessment 1 week prior to training
- Training over 12 weeks
- Assessment 1 week after training
- Assessment 1 month after training (follow-up)
Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. The assessment will consist of:
- Session 1 (at Neuro-Concept clinic) will include presentation of the study and the obtention of written consent, clinical (modified Reaching test and muscle strength), quality of life and functional independence assessments.
- Session 2 (at IURDPM in Dr. Barthélemy's laboratory) will include postural control, corticospinal and cortical assessments.
After the initial assessment, the participants with spinal cord injury will realize 36 sessions of trunk task-oriented training alone or combined with function electrical stimulation (3 times a week for 12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trunk-oriented task combined with functional electrical stimulation training group | Experimental | Other: Trunk-oriented task training combined with functional electrical stimulationThis group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training combined with functional electrical stimulation. |
| Trunk-oriented task training group | Active comparator | Other: Trunk-oriented task training aloneThis group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training. |
| Control group | No intervention | –Healthy participants will be recruited based on the age and sex of the participants with spinal cord injury to realize clinical, biomechanical and cortical evaluations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Level of spinal cord lesion between C6/C7 and T10
- At least, 6 months post-injury
- Be considered as AIS A, B, C or D
- Be able to sit without support for 15 seconds
- Be able to provide informed consent in English or in French
Key exclusion criteria (9 listed)
- To have cognitive deficits
- To wear a corset
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
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 |
|---|---|---|
| Trunk-oriented task training combined with functional electrical stimulationTraining will consist to perform one hour of trunk task-oriented training combined with functional electrical stimulation (FES/T-TOT) specific for muscle strength and motor control. All training will be done seated without support with knees and hips flexed to 90 degrees. FES will be combined with functional and non-functional tasks to work functionality and muscle strengthening. Each training session will consist on the fulfilment of two functional tasks (as reaching) and two non-functional tasks (as push-up movement) from a battery of postural control exercises. | Other | Trunk-oriented task combined with functional electrical stimulation training group |
| Trunk-oriented task training aloneThe SCI participants who will perform T-TOT training alone will have to perform the same exercises as explained in the previous section (two functional tasks and two non-functional tasks) but they will not receive any functional electrical stimulation. Training will consist to perform one hour of trunk task-oriented training (T-TOT) specific for muscle strength and motor control. All training will be done seated without support with knees and hips flexed to 90 degrees. Each training session will consist on the fulfilment of two functional tasks (as reaching) and two non-functional tasks (as push-up movement) from a battery of postural control exercises. | Other | Trunk-oriented task training group |
Primary outcome
Change in Function in Sitting Test
Time frame: Before and after the 12-week trainings and 1-month follow-up
This test evaluates the sitting balance via 14 everyday functional activities rated from 0 to 4 according to the reactions of the participants.
Change in modified Functional Reach Test
Time frame: Before and after the 12-week trainings and every 4-weeks during the training period
This test evaluates the ability for each participant to realize a lateral and anterior trunk flexion in order to observe the maximum distance reached.
4 secondary outcomes
Change in EMG activation pattern of electromyographic activity of muscles in the trunk
Time frame: Before and after the 12-week trainings and 1-month follow-up
Change in the center of pressure excursion
Time frame: Before and after the 12-week trainings and 1-month follow-up
Modification of the excitability of the reticulospinal pathway using the acoustic startle response
Time frame: Before and after the 12-week trainings and 1-month follow-up
Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation
Time frame: Before and after the 12-week trainings and 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk-oriented task training combined with functional electrical stimulation and Trunk-oriented task training alone in people with Spinal Cord Injuries, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 2 sites in Canada.
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 9 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothy Barthélemy, PhD, PT (514-343-7712, dorothy.barthelemy@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Function in Sitting Test (time frame: Before and after the 12-week trainings and 1-month follow-up). The study lists 2 primary outcomes in all. 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 19 Jan 2022.