Spinal Cord InjuriesNCT05200091
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
A study testing Combined explosive strength and specific balance training group in people with Spinal Cord Injuries, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial summary
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Combined explosive strength and specific balance training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2018to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have an incomplete lesion of spinal cord
- Level of spinal cord lesion between C5 and T12
- At least, 6 months post-injury
- Be considered as AIS C or D
- Be able to stand without support for 15 seconds
- Be able to provide informed consent in English or in French
Who cannot join
- To have cognitive deficits
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
- FOR CONTROL PARTICIPANTS
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Neuromobility lab
Montreal, Quebec
Dorothy Barthélemy, PhD, PT, 514-343-7712, dorothy.barthelemy@umontreal.ca
About this study
Official title: Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.
Read the detailed description
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- 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. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:
- Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
- Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.
After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).
- Conditions
- Spinal Cord Injuries
- Being tested
- Combined explosive strength and specific balance training group
- Keywords
- Combined explosive strength and balance training, Balance control, Corticospinal tract, Intracortical mechanisms, Vestibular system
- 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.
Combined explosive strength and specific balance training groupOther
Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations.
Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements.
Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:
- Forward tilt of base of support;
- Backward tilt of base of support;
- Translation forward;
- Translation backward;
- Without moving their feet, participants will have to move their avatar to reach different targets placed around them on the screen, at different distance from the center.
| Study group | Role | What they receive |
|---|---|---|
| Combined explosive strength and specific balance training group | Experimental | This group will be formed with participants with incomplete spinal cord injury. This group will perform 4 weeks of combined explosive strength and specific balance training. Receives: Other: Combined explosive strength and specific balance training group |
| Spinal cord injury control group | No intervention | This group will be formed with participants with incomplete spinal cord injury. They will perform all the evaluation before and after a 4-week period of rest (no training). |
| Healthy control group | No intervention | Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscles EMG responses following balance perturbation
Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
Measured: Pre-intervention, immediately after and one-month after intervention
Change in center of pressure displacement following balance perturbation using a force platform
Excursion of centre of pressure will be analyzed following forward and backward perturbation.
Measured: Pre-intervention, immediately after and one-month after intervention
Change in ankle muscle strength using force transducer
Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
Measured: Pre-intervention, immediately after and one-month after intervention
Secondary outcomes (5)
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
Measured: Pre-intervention, immediately after and one-month after intervention
Change in the influence of peripheral afferents on cortical output using short-afference inhibition
A stimulation (using TMS) at motor cortex level will be triggered just after a peripheral electrical stimulation of tibial nerve to evaluate the peripheral afferents on cortical output.
Measured: Pre-intervention, immediately after and one-month after intervention
Change in the modulation of the H reflex by the corticospinal tract
A stimulation (using TMS) at motor cortex level will be triggered just before a tibial nerve stimulation to evaluate the modulation of the H reflex by the corticospinal tract.
Measured: Pre-intervention, immediately after and one-month after intervention
Change in EMG responses following vestibular stimulations during quiet standing
Galvanic vestibular stimulation will be triggered during quiet standing. EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
Measured: Pre-intervention, immediately after and one-month after intervention
Change in the excursion of the center of pressure following vestibular stimulations
Galvanic vestibular stimulation will be triggered during quiet standing. The displacement of the center of pressure will be analyzed using a force platform.
Measured: Pre-intervention, immediately after and one-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start9 Jul 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200091
- Sponsor's protocol ID
- CRIR 1325-0118
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2021
- Last updated
- 20 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
- ClinicalTrials.gov ID
- NCT05200091
- Acronym / sponsor ID
- CRIR 1325-0118
- Conditions
- Spinal Cord Injuries
- Keywords
- Combined explosive strength and balance training, Balance control, Corticospinal tract, Intracortical mechanisms, Vestibular system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 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 a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.
Detailed description
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- 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. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:
- Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
- Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.
After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined explosive strength and specific balance training group | Experimental | Other: Combined explosive strength and specific balance training groupThis group will be formed with participants with incomplete spinal cord injury. This group will perform 4 weeks of combined explosive strength and specific balance training. |
| Spinal cord injury control group | No intervention | –This group will be formed with participants with incomplete spinal cord injury. They will perform all the evaluation before and after a 4-week period of rest (no training). |
| Healthy control group | No intervention | –Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have an incomplete lesion of spinal cord
- Level of spinal cord lesion between C5 and T12
- At least, 6 months post-injury
- Be considered as AIS C or D
- Be able to stand without support for 15 seconds
Key exclusion criteria (8 listed)
- To have cognitive deficits
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
- FOR CONTROL PARTICIPANTS
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 |
|---|---|---|
| Combined explosive strength and specific balance training groupTraining will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations. Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements. Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions: * Forward tilt of base of support; * Backward tilt of base of support; * Translation forward; * Translation backward; * Without moving their feet, participants will have to move their avatar to reach different targets placed around them on the screen, at different distance from the center. | Other | Combined explosive strength and specific balance training group |
Primary outcome
Change in muscles EMG responses following balance perturbation
Time frame: Pre-intervention, immediately after and one-month after intervention
Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
Change in center of pressure displacement following balance perturbation using a force platform
Time frame: Pre-intervention, immediately after and one-month after intervention
Excursion of centre of pressure will be analyzed following forward and backward perturbation.
Change in ankle muscle strength using force transducer
Time frame: Pre-intervention, immediately after and one-month after intervention
Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
5 secondary outcomes
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Time frame: Pre-intervention, immediately after and one-month after intervention
Change in the influence of peripheral afferents on cortical output using short-afference inhibition
Time frame: Pre-intervention, immediately after and one-month after intervention
Change in the modulation of the H reflex by the corticospinal tract
Time frame: Pre-intervention, immediately after and one-month after intervention
Change in EMG responses following vestibular stimulations during quiet standing
Time frame: Pre-intervention, immediately after and one-month after intervention
Change in the excursion of the center of pressure following vestibular stimulations
Time frame: Pre-intervention, immediately after and one-month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined explosive strength and specific balance training group in people with Spinal Cord Injuries, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site 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 6 inclusion and 8 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 20 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 1 site 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 muscles EMG responses following balance perturbation (time frame: Pre-intervention, immediately after and one-month after intervention). The study lists 3 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 20 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.