Sensorimotor DisorderIMPULSESNCT05367791
Improving Postural Control Through Innovative Stimulation of the Proprioceptive System
A study testing POSTUR, Localised Vibration and Somatosensory Electrical Stimulation in people with Sensorimotor Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Every movement humans make in everyday life is based on a continuous integration of sensory information. A good interaction between sensory processes and motor control, called sensorimotor integration, is necessary for the efficiency of movements. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensorimotor Disorder
- What is being tested?
- POSTUR, Localised Vibration and Somatosensory Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2022to 22 Jul 2024
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Older Adults:
- Affiliated or beneficiaries of a social security plan
- Who have freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved
- Children with Cerebral Palsy:
- Children between the ages of 7 and 18 years, diagnosed with Spastic Cerebral Palsy, presenting with a clinical picture of infantile cerebral hemiplegia or diplegia.
- Children able to understand and follow the simple instructions of the examination
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- Children walking GMFCS (Gross Motor Functional Classification system) I to II.
- Children with at least one parent and the child having given and signed the consent agreement
- Children who are members or beneficiaries of a social security system
Who cannot join
- Older adults:
- Pathology or surgery resulting in a locomotor disorder, within 6 months prior to the study,
- Chronic neurological, motor or psychological pathologies
- Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, anti-epileptics, psychotropic drugs, muscle relaxants) during the study.
- Contraindication to transcranial magnetic stimulation:
- Cardiac or respiratory insufficiency.
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- Wearing a cardiac pace maker.
- Wearing a heart valve and severe cardiovascular diseases.
- Presence of prosthetic material or ferromagnetic foreign bodies in the head.
- Presence of cochlear implants or ocular prosthetic material.
- History of neurosurgical procedures.
- Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumor, multiple sclerosis, history of stroke or head injury).
- Participation at the same time in another interventional trial or having participated in a such a study within 30 days prior to this study.
- Obesity (body mass index ≥ 30.0 kg/m²)
- Children with cerebral palsy:
- Children with concomitant muscle disease (e.g., myopathy...).
- Children who have received a baclofen injection in the 6 months preceding the evaluation.
- Children who have undergone neuro-orthopedic surgery on the lower limbs within the last 6 months
- Children who have received a botulinum toxin injection within the last 6 months
- Children participating in therapeutic programs other than their usual physical therapy sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Every movement humans make in everyday life is based on a continuous integration of sensory information. A good interaction between sensory processes and motor control, called sensorimotor integration, is necessary for the efficiency of movements. Sensorimotor integration in the context of posture and walking is based on proprioception. Proprioception is the conscious and unconscious perception of the spatial and mechanical state of the musculoskeletal system. Proprioceptive information transmitted through the neuromuscular spindles in particular is suggested to play a role in motor rehabilitation.
Read the detailed description
This is particularly important when considering populations with impaired proprioception resulting in impaired posture and gait control. This is particularly the case for older adults and children with cerebral palsy (CP). Nevertheless, drastic differences exist between the two populations in the nature of these alterations: stable (children with CP) vs. progressive (older adults); brain lesion/upper motor neuron (children with CP) vs. processing deficits and peripheral sensory degradation (older adults); growing (children with CP) vs. fully developed individuals (older adults). However, both populations can improve their postural control with postural exercise programmes. In humans, the proprioceptive system can also be stimulated non-invasively by mechanical vibrations applied to tendons or muscles (localised vibration; LV), or by electrical stimulation of peripheral nerves (somatosensory electrical stimulation; SES). As a result, chronically applied SES can improve sensorimotor function in healthy adults and some clinical cohorts. Similarly, a 6-week weight-bearing and weight-shifting training programme combined with LV has been reported to provide improved benefits in postural control, again in stroke patients.The greater improvement in motor function when LV or SES is added to active muscles may reflect an adjuvant effect: the sensory signal from LV or SES stimulation is integrated with the sensory signals from the task being performed, thus acting as an associative conditioning of the proprioceptive system, and leading to improved sensorimotor integration. The present project aims to study the effectiveness of a short-term intervention combining postural exercises with LV, SES, or the combination of both.
In particular, this study will focus on the effects of these interventions on proprioception, postural control and walking in children with CP and older adults.Confirmation of hypotheses will open up new avenues for rehabilitation therapies and preventive interventions, and may be extended to other purposes and clinical populations.
- Conditions
- Sensorimotor Disorder
- Being tested
- POSTUR, Localised Vibration, Somatosensory Electrical Stimulation
- Keywords
- Postural exercise, Localized vibration, Somatosensory electrical stimulation, Altered posture, Walking control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSTUROther
Training sessions without any stimulation
Localised VibrationOther
Training sessions with localized vibration
Somatosensory Electrical StimulationOther
Training sessions with somatosensory electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| POSTUR | Other | Postural training only. Receives: Other: POSTUR |
| POSTUR + LV (localized vibration) | Other | Postural training combined with localized vibration Receives: Other: POSTUR; Other: Localised Vibration |
| POSTUR+SES (somatosensory electrical stimulation) | Other | Postural training combined with somatosensory electrical stimulation Receives: Other: POSTUR; Other: Somatosensory Electrical Stimulation |
| POSTUR+LV-SES | Other | Postural training combined with somatosensory electrical stimulation and localized vibration Receives: Other: POSTUR; Other: Localised Vibration; Other: Somatosensory Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of body balance with the Berg Balance Scale (BBS)
Variation of postural control
Measured: Change from Week 8 to Week 16
Secondary outcomes (10)
Evaluation of body balance with the Berg Balance Scale (BBS)
Variation of postural control
Measured: Change from Week 1 to Week 22
Evaluation of the displacement of the center of pressure with force platform in centimeter
Variation of postural control
Measured: Change from Week 1 to Week 22
Displacement of the centrer of pressure with application of localized vibration in centimeter
Proprioceptive contribution to postural control
Measured: Change from Week 1 to Week 22
Measure of the angular position error in degrees
Variation of the position direction
Measured: Change from Week 1 to Week 22
Coefficient of variation muscle force control in percent
Muscle force control measurement
Measured: Change from Week 1 to Week 22
Measure 6-minute walk test (6MWT) in meters
Walking ability evaluation
Measured: Change from Week 1 to Week 22
Measure Timed Up & Go Test (TUG) in seconds
Walking ability evaluation
Measured: Change from Week 1 to Week 22
Measure 10 meter walk test (10MWT) in seconds
Walking ability evaluation
Measured: Change from Week 1 to Week 22
Quantifying corticospinal excitability with motor evoked potentials in milliVolt
Underlying neural adaptations evaluation in older adults only
Measured: Change from Week 1 to Week 22
Quantifying spinal excitability with H-reflex in milliVolt
Underlying neural adaptations evaluation in older adults only
Measured: Change from Week 1 to Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start29 Jun 2022
- Primary completion7 Feb 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorimotor DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard Feasson, PHD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367791
- Sponsor's protocol ID
- 21CH160
- Other IDs
- 2021-A02416-35
- Acronym
- IMPULSES
- Status last verified
- Jul 2024
- First submitted
- 2 May 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Postural Control Through Innovative Stimulation of the Proprioceptive System
- ClinicalTrials.gov ID
- NCT05367791
- Acronym / sponsor ID
- IMPULSES / 21CH160
- Conditions
- Sensorimotor Disorder
- Keywords
- Postural exercise, Localized vibration, Somatosensory electrical stimulation, Altered posture, Walking control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 10 May 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.
Every movement humans make in everyday life is based on a continuous integration of sensory information. A good interaction between sensory processes and motor control, called sensorimotor integration, is necessary for the efficiency of movements. Sensorimotor integration in the context of posture and walking is based on proprioception. Proprioception is the conscious and unconscious perception of the spatial and mechanical state of the musculoskeletal system. Proprioceptive information transmitted through the neuromuscular spindles in particular is suggested to play a role in motor rehabilitation.
Detailed description
This is particularly important when considering populations with impaired proprioception resulting in impaired posture and gait control. This is particularly the case for older adults and children with cerebral palsy (CP). Nevertheless, drastic differences exist between the two populations in the nature of these alterations: stable (children with CP) vs. progressive (older adults); brain lesion/upper motor neuron (children with CP) vs. processing deficits and peripheral sensory degradation (older adults); growing (children with CP) vs. fully developed individuals (older adults). However, both populations can improve their postural control with postural exercise programmes. In humans, the proprioceptive system can also be stimulated non-invasively by mechanical vibrations applied to tendons or muscles (localised vibration; LV), or by electrical stimulation of peripheral nerves (somatosensory electrical stimulation; SES). As a result, chronically applied SES can improve sensorimotor function in healthy adults and some clinical cohorts. Similarly, a 6-week weight-bearing and weight-shifting training programme combined with LV has been reported to provide improved benefits in postural control, again in stroke patients.The greater improvement in motor function when LV or SES is added to active muscles may reflect an adjuvant effect: the sensory signal from LV or SES stimulation is integrated with the sensory signals from the task being performed, thus acting as an associative conditioning of the proprioceptive system, and leading to improved sensorimotor integration. The present project aims to study the effectiveness of a short-term intervention combining postural exercises with LV, SES, or the combination of both.
In particular, this study will focus on the effects of these interventions on proprioception, postural control and walking in children with CP and older adults.Confirmation of hypotheses will open up new avenues for rehabilitation therapies and preventive interventions, and may be extended to other purposes and clinical populations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POSTUR | Other | Other: POSTURPostural training only. |
| POSTUR + LV (localized vibration) | Other | Other: POSTUR, Other: Localised VibrationPostural training combined with localized vibration |
| POSTUR+SES (somatosensory electrical stimulation) | Other | Other: POSTUR, Other: Somatosensory Electrical StimulationPostural training combined with somatosensory electrical stimulation |
| POSTUR+LV-SES | Other | Other: POSTUR, Other: Localised Vibration, Other: Somatosensory Electrical StimulationPostural training combined with somatosensory electrical stimulation and localized vibration |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Affiliated or beneficiaries of a social security plan
- Who have freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved
- Children between the ages of 7 and 18 years, diagnosed with Spastic Cerebral Palsy, presenting with a clinical picture of infantile cerebral hemiplegia or diplegia.
- Children able to understand and follow the simple instructions of the examination
- Children walking GMFCS (Gross Motor Functional Classification system) I to II.
Key exclusion criteria (20 listed)
- Pathology or surgery resulting in a locomotor disorder, within 6 months prior to the study,
- Chronic neurological, motor or psychological pathologies
- Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, anti-epileptics, psychotropic drugs, muscle relaxants) during the study.
- Contraindication to transcranial magnetic stimulation:
- Participation at the same time in another interventional trial or having participated in a such a study within 30 days prior to this study.
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 |
|---|---|---|
| POSTURTraining sessions without any stimulation | Other | POSTUR, POSTUR + LV (localized vibration), POSTUR+LV-SES, POSTUR+SES (somatosensory electrical stimulation) |
| Localised VibrationTraining sessions with localized vibration | Other | POSTUR + LV (localized vibration), POSTUR+LV-SES |
| Somatosensory Electrical StimulationTraining sessions with somatosensory electrical stimulation | Other | POSTUR+LV-SES, POSTUR+SES (somatosensory electrical stimulation) |
Primary outcome
Evaluation of body balance with the Berg Balance Scale (BBS)
Time frame: Change from Week 8 to Week 16
Variation of postural control
10 secondary outcomes
Evaluation of body balance with the Berg Balance Scale (BBS)
Time frame: Change from Week 1 to Week 22
Evaluation of the displacement of the center of pressure with force platform in centimeter
Time frame: Change from Week 1 to Week 22
Displacement of the centrer of pressure with application of localized vibration in centimeter
Time frame: Change from Week 1 to Week 22
Measure of the angular position error in degrees
Time frame: Change from Week 1 to Week 22
Coefficient of variation muscle force control in percent
Time frame: Change from Week 1 to Week 22
Measure 6-minute walk test (6MWT) in meters
Time frame: Change from Week 1 to Week 22
Measure Timed Up & Go Test (TUG) in seconds
Time frame: Change from Week 1 to Week 22
Measure 10 meter walk test (10MWT) in seconds
Time frame: Change from Week 1 to Week 22
Quantifying corticospinal excitability with motor evoked potentials in milliVolt
Time frame: Change from Week 1 to Week 22
Quantifying spinal excitability with H-reflex in milliVolt
Time frame: Change from Week 1 to Week 22
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 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Leonard Feasson, PHD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POSTUR, Localised Vibration and Somatosensory Electrical Stimulation in people with Sensorimotor Disorder, run by Centre Hospitalier Universitaire de Saint Etienne 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 9 inclusion and 20 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 29 Jul 2024. 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 body balance with the Berg Balance Scale (BBS) (time frame: Change from Week 8 to Week 16). 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 29 Jul 2024.