Balance, PosturalManEqNCT05475652
The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly
A study testing Manual therapy in people with Balance, Postural and Gait, run by EZUS-LYON 1 at 1 site in France.
Trial summary
Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance, Postural, Gait, Elderly
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2020to 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older, of either sex
- Autonomous, able to walk ten meters alone without walking aid
- Able to understand instructions necessary for the correct performance of the measurements.
Who cannot join
- Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
- Patient who has an history of surgery - fracture - dislocation of the cervical spine
- Patient who has cognitive impairments (Mini Mental Statement <20)
- Patient who has life expectancy less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Manual Therapy Applied to the Cervical Spine (Versus Light Touch) in the Prevention of Balance Disorders in the Elderly: a Randomized Controlled Trial
Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.
Read the detailed description
The main hypothesis of the present study is therefore that manual therapy applied to the cervical spine may have a beneficial impact on the balance and motor performance of seniors. The study also aims to propose an assessment of the physical parameters of balance, in order to validate the contribution of the cervical spine in compensatory mechanisms.
To do so, an interventional study was designed, monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21.
- Conditions
- Balance, Postural, Gait, Elderly
- Being tested
- Manual therapy, Placebo intervention
- Keywords
- senior;, gait, neck, myofascial release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
The manual therapy intervention is performed twice on the experimental group, once on day 0 (D0) and the second time on day 7 (D7). This intervention consists of a manual therapy protocol (base on myofascial release) applied to the cervical spine. Protocol consists of succession of techniques: suboccipital decompression, disengagement of Cervical 0-1-2,vibratory stimulation at C4 level and myofascial release technique of the cervical aponeuroses. Outcomes are evaluated before and after intervention.The same schedule will be reproduced on D7. On D21, only one assessment will be done at the beginning of the session.
Placebo interventionOther
The Sham group receives placebo treatment twice (D0 and D7). This placebo treatment also called "light touch" treatment consists of applying light pressure with broad support from both hands on either side of the joint, in contact with the skin, without equal bone pressure or therapeutic intention, for a duration comparable to that of manual therapy. Outcomes are evaluation before and after placebo intervention. The same schedule will be reproduced at D7. On D21, only one assessment will be done at the beginning of the session and a manual therapy treatment on the cervical spine is provided to balance access to care in the two group
| Study group | Role | What they receive |
|---|---|---|
| Sham (ligth touch) | Sham comparator | Placebo intervention composed of light touch treatment on the cervical spine. Receives: Other: Placebo intervention |
| Manual therapy | Experimental | Manual therapy applied to the cervical spine. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
Measured: at Day 0 before and immediately after intervention in both groups
change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
Measured: at Day 7 before and immediately after intervention in both groups
SPPB (Short Physical Performance Battery test) score at day 21
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
Measured: at Day 21 in both groups before the intervention for sham group
change of walking speed at day 0 after 1 intervention
The subject will performed a 4m gait measurement
Measured: at Day 0 before and immediately after intervention in both groups
change of walking speed at day 7 after a second intervention intervention
The subject will performed a 4m gait measurement
Measured: at Day 7 before and immediately after intervention in both groups
walking speed at day 21
The subject will performed a 4m gait measurement
Measured: at Day 21 in both groups, before the intervention for sham group
Secondary outcomes (18)
change in Heart Rate Variability at day 0 after 1 intervention
Participants will be equipped with a heart rate monitor (Polar RS800) and a heart belt to collect HRV. The watch will be placed on the subjects' wrists and the belt on the chest (under the pectoral muscles for men and under the bra for women). The skin under the sensor will be slightly moistened to ensure good electrical contact and to avoid artifacts. The belt must be tight enough to ensure that the sensor is in perfect contact with the skin but must remain comfortable. Thus, a total recording time of 5 minutes, in the supine position and with spontaneous breathing, will be performed on each patient.
Measured: at Day 0 before and immediately after intervention in both groups
change in Heart Rate Variability at day 7 after the second intervention
Participants will be equipped with a heart rate monitor (Polar RS800) and a heart belt to collect HRV. The watch will be placed on the subjects' wrists and the belt on the chest (under the pectoral muscles for men and under the bra for women). The skin under the sensor will be slightly moistened to ensure good electrical contact and to avoid artifacts. The belt must be tight enough to ensure that the sensor is in perfect contact with the skin but must remain comfortable. Thus, a total recording time of 5 minutes, in the supine position and with spontaneous breathing, will be performed on each patient.
Measured: at Day 7 before and immediately after intervention in both groups
Heart Rate Variability at day 21
Participants will be equipped with a heart rate monitor (Polar RS800) and a heart belt to collect HRV. The watch will be placed on the subjects' wrists and the belt on the chest (under the pectoral muscles for men and under the bra for women). The skin under the sensor will be slightly moistened to ensure good electrical contact and to avoid artifacts. The belt must be tight enough to ensure that the sensor is in perfect contact with the skin but must remain comfortable. Thus, a total recording time of 5 minutes, in the supine position and with spontaneous breathing, will be performed on each patient.
Measured: at Day 21 before the intervention for sham group
change in cervical range of motion at day 0 after 1 intervention
the patients will be seated in a neutral position, with their backs against the back of the chair, and will perform the cervical range of motion tests. For this, the experimenter will use the anatomical points previously identified: ear tragus, chin symphysis, anterior angle of the acromion, sternal incisure. The subject will be asked to perform movements of flexion, extension, right rotation, left rotation, right tilt, and left tilt, returning to the neutral position each time. All movements will be performed 3 times. The measurement will retain the difference between the neutral position and the maximum position of the movement
Measured: at Day 0 before and immediately after intervention in both groups
change in cervical range of motion at day 7 after the second intervention
the patients will be seated in a neutral position, with their backs against the back of the chair, and will perform the cervical range of motion tests. For this, the experimenter will use the anatomical points previously identified: ear tragus, chin symphysis, anterior angle of the acromion, sternal incisure. The subject will be asked to perform movements of flexion, extension, right rotation, left rotation, right tilt, and left tilt, returning to the neutral position each time. All movements will be performed 3 times. The measurement will retain the difference between the neutral position and the maximum position of the movement
Measured: at Day 7 before and immediately after intervention in both groups
cervical range of motion at day 21
the patients will be seated in a neutral position, with their backs against the back of the chair, and will perform the cervical range of motion tests. For this, the experimenter will use the anatomical points previously identified: ear tragus, chin symphysis, anterior angle of the acromion, sternal incisure. The subject will be asked to perform movements of flexion, extension, right rotation, left rotation, right tilt, and left tilt, returning to the neutral position each time. All movements will be performed 3 times. The measurement will retain the difference between the neutral position and the maximum position of the movement
Measured: at Day 21 before the intervention for sham group
change in cervical muscle strength at day 0 after 1 intervention
the cervical strength tests will be performed seated too, using a manual dynamometer (Micro FET2, Hoggan, Salt Lake City, USA). To obtain the maximum isometric force of the neck muscles in the 6 movements, a "make test" will be performed: the experimenter will resist the subject's force without trying to exceed it. The subject will be asked to perform progressively and as hard as possible, from the neutral position, a flexion movement (resistance applied under the chin), an extension movement (resistance applied to the back of the occiput), a right and left rotation movement (resistance applied along the horizontal side of the right and left mandibles), and a right and left tilt movement (resistance applied above the right and left ears).
Measured: at Day 0 before and immediately after intervention in both groups
change in cervical muscle strength at day 7 after the second intervention
the cervical strength tests will be performed seated too, using a manual dynamometer (Micro FET2, Hoggan, Salt Lake City, USA). To obtain the maximum isometric force of the neck muscles in the 6 movements, a "make test" will be performed: the experimenter will resist the subject's force without trying to exceed it. The subject will be asked to perform progressively and as hard as possible, from the neutral position, a flexion movement (resistance applied under the chin), an extension movement (resistance applied to the back of the occiput), a right and left rotation movement (resistance applied along the horizontal side of the right and left mandibles), and a right and left tilt movement (resistance applied above the right and left ears).
Measured: at Day 7 before and immediately after intervention in both groups
cervical muscle strength at day 21
the cervical strength tests will be performed seated too, using a manual dynamometer (Micro FET2, Hoggan, Salt Lake City, USA). To obtain the maximum isometric force of the neck muscles in the 6 movements, a "make test" will be performed: the experimenter will resist the subject's force without trying to exceed it. The subject will be asked to perform progressively and as hard as possible, from the neutral position, a flexion movement (resistance applied under the chin), an extension movement (resistance applied to the back of the occiput), a right and left rotation movement (resistance applied along the horizontal side of the right and left mandibles), and a right and left tilt movement (resistance applied above the right and left ears).
Measured: at Day 21 before the intervention for sham group
change in quadriceps strength at day 0 after 1 intervention
to measure the maximal isometric extension force of the dominant quadriceps by applying the dynamometer to the lower tibia and requesting leg extension from a 90° flexion position
Measured: At Day 0 before and immediately after intervention in both groups
change in quadriceps strength at day 7 after the second intervention
to measure the maximal isometric extension force of the dominant quadriceps by applying the dynamometer to the lower tibia and requesting leg extension from a 90° flexion position
Measured: At Day 7 before and immediately after intervention in both groups
quadriceps strength at day 21
to measure the maximal isometric extension force of the dominant quadriceps by applying the dynamometer to the lower tibia and requesting leg extension from a 90° flexion position
Measured: At Day 21 before the intervention for sham group
change in static posturography at day 0 after 1 intervention
the static posturography test will be performed under standard conditions using the WIN-POSTURO platform (Medicapteur, Balma, France) allowing the measurement of displacements of the center of pressure in a static standing position at a frequency of 40 Hz for 25.6 seconds
. The measurement will be repeated 3 times. The data collected will be processed using WIN-POSTURO software (Medicapteur, Balma, France)
Measured: At Day 0 before and immediately after intervention in both groups
change in static posturography at day 7 after the second intervention
the static posturography test will be performed under standard conditions using the WIN-POSTURO platform (Medicapteur, Balma, France) allowing the measurement of displacements of the center of pressure in a static standing position at a frequency of 40 Hz for 25.6 seconds
. The measurement will be repeated 3 times. The data collected will be processed using WIN-POSTURO software (Medicapteur, Balma, France)
Measured: At Day 7 before and immediately after intervention in both groups
static posturography at day 21
the static posturography test will be performed under standard conditions using the WIN-POSTURO platform (Medicapteur, Balma, France) allowing the measurement of displacements of the center of pressure in a static standing position at a frequency of 40 Hz for 25.6 seconds
. The measurement will be repeated 3 times. The data collected will be processed using WIN-POSTURO software (Medicapteur, Balma, France)
Measured: At Day 21 before the intervention for sham group
change in plantar support at day 0 after 1 intervention
The subject will perform the 4 m gait measurement part (which will measure walking speed) equipped with W-INSHOE plantar sensors (Medicapteur, Balam, France) which will be analyzed using the software of the same name. The sensors are attached to the skin with hypoallergenic tape
Measured: At Day 0 before and immediately after intervention in both groups
change in plantar support at day 7 after the second intervention
The subject will perform the 4 m gait measurement part (which will measure walking speed) equipped with W-INSHOE plantar sensors (Medicapteur, Balam, France) which will be analyzed using the software of the same name. The sensors are attached to the skin with hypoallergenic tape
Measured: At Day 7 before and immediately after intervention in both groups
plantar support at day 21
The subject will perform the 4 m gait measurement part (which will measure walking speed) equipped with W-INSHOE plantar sensors (Medicapteur, Balam, France) which will be analyzed using the software of the same name. The sensors are attached to the skin with hypoallergenic tape
Measured: At Day 21 before the intervention for sham group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start4 Feb 2020
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Balance, PosturalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- EZUS-LYON 1
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurianne PINLOCHE, MD, Principal investigator, Laboratoire Interuniversitaire de Biologie de la Motricité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475652
- Sponsor's protocol ID
- 002B2019
- Acronym
- ManEq
- Status last verified
- Jul 2022
- First submitted
- 20 May 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.
PubMed 36045446
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Manual Therapy Applied to the Cervical Spine (Versus Light Touch) in the Prevention of Balance Disorders in the Elderly: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05475652
- Acronym / sponsor ID
- ManEq / 002B2019
- Conditions
- Balance, Postural, Gait, Elderly
- Keywords
- senior;, gait, neck, myofascial release
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- EZUS-LYON 1University, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jul 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.
Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.
Detailed description
The main hypothesis of the present study is therefore that manual therapy applied to the cervical spine may have a beneficial impact on the balance and motor performance of seniors. The study also aims to propose an assessment of the physical parameters of balance, in order to validate the contribution of the cervical spine in compensatory mechanisms.
To do so, an interventional study was designed, monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham (ligth touch) | Sham comparator | Other: Placebo interventionPlacebo intervention composed of light touch treatment on the cervical spine. |
| Manual therapy | Experimental | Other: Manual therapyManual therapy applied to the cervical spine. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years of age or older, of either sex
- Autonomous, able to walk ten meters alone without walking aid
- Able to understand instructions necessary for the correct performance of the measurements.
Key exclusion criteria (4 listed)
- Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
- Patient who has an history of surgery - fracture - dislocation of the cervical spine
- Patient who has cognitive impairments (Mini Mental Statement <20)
- Patient who has life expectancy less than 6 months.
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 |
|---|---|---|
| Manual therapyThe manual therapy intervention is performed twice on the experimental group, once on day 0 (D0) and the second time on day 7 (D7). This intervention consists of a manual therapy protocol (base on myofascial release) applied to the cervical spine. Protocol consists of succession of techniques: suboccipital decompression, disengagement of Cervical 0-1-2,vibratory stimulation at C4 level and myofascial release technique of the cervical aponeuroses. Outcomes are evaluated before and after intervention.The same schedule will be reproduced on D7. On D21, only one assessment will be done at the beginning of the session. | Other | Manual therapy |
| Placebo interventionThe Sham group receives placebo treatment twice (D0 and D7). This placebo treatment also called "light touch" treatment consists of applying light pressure with broad support from both hands on either side of the joint, in contact with the skin, without equal bone pressure or therapeutic intention, for a duration comparable to that of manual therapy. Outcomes are evaluation before and after placebo intervention. The same schedule will be reproduced at D7. On D21, only one assessment will be done at the beginning of the session and a manual therapy treatment on the cervical spine is provided to balance access to care in the two group | Other | Sham (ligth touch) |
Primary outcome
change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention
Time frame: at Day 0 before and immediately after intervention in both groups
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention
Time frame: at Day 7 before and immediately after intervention in both groups
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
SPPB (Short Physical Performance Battery test) score at day 21
Time frame: at Day 21 in both groups before the intervention for sham group
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
change of walking speed at day 0 after 1 intervention
Time frame: at Day 0 before and immediately after intervention in both groups
The subject will performed a 4m gait measurement
change of walking speed at day 7 after a second intervention intervention
Time frame: at Day 7 before and immediately after intervention in both groups
The subject will performed a 4m gait measurement
walking speed at day 21
Time frame: at Day 21 in both groups, before the intervention for sham group
The subject will performed a 4m gait measurement
18 secondary outcomes
change in Heart Rate Variability at day 0 after 1 intervention
Time frame: at Day 0 before and immediately after intervention in both groups
change in Heart Rate Variability at day 7 after the second intervention
Time frame: at Day 7 before and immediately after intervention in both groups
Heart Rate Variability at day 21
Time frame: at Day 21 before the intervention for sham group
change in cervical range of motion at day 0 after 1 intervention
Time frame: at Day 0 before and immediately after intervention in both groups
change in cervical range of motion at day 7 after the second intervention
Time frame: at Day 7 before and immediately after intervention in both groups
cervical range of motion at day 21
Time frame: at Day 21 before the intervention for sham group
change in cervical muscle strength at day 0 after 1 intervention
Time frame: at Day 0 before and immediately after intervention in both groups
change in cervical muscle strength at day 7 after the second intervention
Time frame: at Day 7 before and immediately after intervention in both groups
cervical muscle strength at day 21
Time frame: at Day 21 before the intervention for sham group
change in quadriceps strength at day 0 after 1 intervention
Time frame: At Day 0 before and immediately after intervention in both groups
change in quadriceps strength at day 7 after the second intervention
Time frame: At Day 7 before and immediately after intervention in both groups
quadriceps strength at day 21
Time frame: At Day 21 before the intervention for sham group
change in static posturography at day 0 after 1 intervention
Time frame: At Day 0 before and immediately after intervention in both groups
change in static posturography at day 7 after the second intervention
Time frame: At Day 7 before and immediately after intervention in both groups
static posturography at day 21
Time frame: At Day 21 before the intervention for sham group
change in plantar support at day 0 after 1 intervention
Time frame: At Day 0 before and immediately after intervention in both groups
change in plantar support at day 7 after the second intervention
Time frame: At Day 7 before and immediately after intervention in both groups
plantar support at day 21
Time frame: At Day 21 before the intervention for sham group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 36045446Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.
- Individual participant dataSharing planned: No
Related trials for Balance, Postural
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
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.
Laurianne PINLOCHE, MD principal investigator
Laboratoire Interuniversitaire de Biologie de la Motricité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Balance, Postural and Gait, run by EZUS-LYON 1 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 3 inclusion and 4 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 28 Jul 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 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. Some participants in this study may receive a placebo. 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?
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?
change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention (time frame: at Day 0 before and immediately after intervention in both groups). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475652, which also lists 1 linked publication.
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 2022.