Multiple SclerosisEXOSEPNCT06702137

EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

A study testing EXOPULSE MOLLII SUIT (active) in people with Multiple Sclerosis, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). It can alter the patients' balance, mobility, as well as their quality of life. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: EXOPULSE MOLLII SUIT (active)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteFrance
Study dates: 1 Jun 2022to 14 May 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
Age between 18 and 75 years.
Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) < 7).
Being free of relapses in the last three months.
Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
Having spasticity with a score of at least 1+ on the MAS.
Having a BBS score ≤46 associated in the literature with a risk of fall

Who cannot join

Being included in another research protocol during the study period.
Inability to undergo medical monitoring for the study purposes due to geographical or social reasons.
Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit.
Being pregnant.
Having a change in their pharmacological therapy in the last three months.
Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).

Show all 10Show fewer

Having a body mass index above 35 Kg/m2.
In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period
Patients under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
Prisoners.

Trial locations and contacts

1 site in 1 country.

France1 site

Clinical Neurophysiology Department, Henri Mondor Hospital
Créteil, VAL DE MARNE, 94000

Other trials in France

About this study

Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP Study)

For these reasons, non invasive stimulation techniques, namely transcutaneous stimulation by means of EXOPULSE Mollii suit, might be of help in this context.

Read the detailed description

The investigators designed a randomized crossover, sham-controlled, double blind trial to demonstrate the improvement of motor functions and MS related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over four weeks (a session every other day for a total of 14 sessions) on MS related symptoms.

Conditions: Multiple Sclerosis
Being tested: EXOPULSE MOLLII SUIT (active), EXOPULSE MOLLII SUIT (sham)
Keywords: Spasticity, Motor Functions, Quality of life
Medical subject headings: Multiple Sclerosis, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EXOPULSE MOLLII SUIT (active)Device
This study aims to evaluate the effects of the EXOPULSE Mollii suit, a non-invasive assistive device that delivers transcutaneous electrostimulation. The suit includes a CE-labeled class IIa control unit and class I body garments. Equipped with 58 electrodes, the full-body suit stimulates various muscle groups to reduce spasticity by activating antagonistic muscles through reciprocal inhibition, rather than causing muscle contractions. Designed to relax spastic muscles, improve range of motion, prevent atrophy, enhance circulation, and provide pain relief, the device is easy to use, requiring only one hour of daily wear, with effects lasting over 24 hours.
Current treatments for spasticity, such as botulinum toxin and oral medications, have limitations like side effects and minimal mobility improvement. The EXOPULSE Mollii suit offers an innovative alternative, with early studies indicating positive impacts on mobility and motor function.
EXOPULSE MOLLII SUIT (sham)Device
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Study groups in NCT06702137
Study group	Role	What they receive
Experimental Condition	Active comparator	Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted. EXOPULSE Mollii Suit is used for the activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax. Receives: Device: EXOPULSE MOLLII SUIT (active)
Control Condition	Sham comparator	In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour). Receives: Device: EXOPULSE MOLLII SUIT (sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in balance using the BBS (Berg Balance Scale) )
Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in PwMS (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.
Measured: BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)

Secondary outcomes (11)

Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale) after 4 weeks of using Exopulse Molii Suit
BBS has good psychometric properties in PwMS (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with fall risk across the literature.
Measured: BBS evaluation will occur at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Assessment of the spasticity using the MAS (Modified Ashworth Scale)
Spasticity will be evaluated by examiners using the MAS (Modified Ashworth Scale)
Measured: Spasticity according to MAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Assessment of the spasticity using the VAS spasticity (Visual Analogue Scale)
Spasticity will be evaluated by patients using a VAS (Visual Analogue Scale)
Measured: VAS spasicity will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Mobility will be assessed using the TUG (Time Up and Go)
The TUG is a validated test that assesses walking in PwMS (Bennett et al., 2017). The score is expressed as the time (in seconds) required to perform sequential motor tasks (standing up from the chair, walking to the line on the floor at a normal pace, turning, walking back to the chair at a normal pace, and finally sitting down).
Measured: Mobility according to TUG will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
Subjective risk of fall will be assessed using the French version of the Falls Efficacy Scale-International scale (FES-I) ; a 14-item scale that assesses the perceived risk of falling.
Measured: FES-I will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)
Subjective changes in walking would be evaluated by the Multiple Sclerosis Walking Scale - 12 (MSWS-12), a 12-item scale that examines the impact of MS on walking capacity, is a validated patient-reported measure for exploring this outcome.
Measured: MSWS-12 will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Quality of life will be measured using the MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire)
This variable will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL), which has good psychometric properties and yields a total score and subscores for nine dimensions: activity of daily living, psychological well-being, symptoms, friends' relationships, family relationships, satisfaction with health care, sentimental and sexual life, coping and rejection.
Measured: MusiQOL will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Pain will be assessed using a VAS (Visual Analogue Scale)
VAS is a 10 mm straight horizontal line with one end meaning no pain and the other end meaning the worst pain imaginable
Measured: Pain according to VAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Fatigue will be assessed using a VAS (Visual Analogue Scale)
VAS is a 10 mm straight horizontal line with one end meaning no fatigue and the other end meaning extreme fatigue
Measured: Fatigue according to VAS be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Evaluation of overall improvement using the CGI (Clinical Global Impression)
It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)
Measured: CGI will be assessed at Day 1 (after the intervention, phase 1), at Day 15 (after the intervention, phase 1) and at Day 60 (at the end of phase 2)
Evaluation of patient's blinding to the type of stimulation in the crossover trial
This blind evaluation will be done in phase 1 using a dedicated questionnaire (only for each treatment condition, since all patients will receive the same active treatment in open phase 2).
Measured: Blinding wil be assessed at Day 1 (after the intervention) and at Day 15 (after the intervention) during Phase 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202214 May 2024

First posted22 Nov 2024
Study start1 Jun 2022
Primary completion2 Apr 2024
Study completion14 May 2024

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 Multiple SclerosisStudies 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: Crossover
Model description: It is a randomized, controlled, double-blind, and cross-over study. Phase 1 is a randomized, controlled, double-blind, and cross-over study. In this phase, each participant will be randomly assigned to receive one session of active stimulation and one session of sham stimulation using the EXOPULSE Mollii suit (phase 1). The crossover design is appropriate for assessing symptomatic treatment of this chronic and relatively stable disease. Furthermore, the sessions will be separated by a wash-out interval of two weeks. Thus, a 2-week washout period should be enough to prevent a potential carry-over effect. At the end of phase 1 (two weeks after the second session of active or sham), an open-label phase (phase 2) will be proposed for all patients and will consist of 4 weeks of active stimulation (every other day stimulations for a total of 14 sessions). In total, each participant will be included in the study for 8 weeks (4 weeks for phase 1 and 4 weeks for phase 2).
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06702137
Sponsor's protocol ID: 2022-A00231-42
Acronym: EXOSEP
Status last verified: Feb 2025
First submitted: 2 Nov 2024
Last updated: 18 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ayache SS, Mattar JG, Creange A, Abdellaoui M, Zedet M, Lefaucheur JP, Megherbi H, Khaled H, Abi Lahoud GN, Chalah MA. The effect of the EXOPULSE Mollii suit on motor functions in patients with multiple sclerosis - a randomized sham-controlled crossover trial. Mult Scler J Exp Transl Clin. 2025 Jun 19;11(2):20552173251348304. doi: 10.1177/20552173251348304. eCollection 2025 Apr-Jun.
PubMed 40547078

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP Study)
ClinicalTrials.gov ID: NCT06702137
Acronym / sponsor ID: EXOSEP / 2022-A00231-42
Conditions: Multiple Sclerosis
Keywords: Spasticity, Motor Functions, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Institut De La Colonne Vertebrale Et Des NeurosciencesUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 2 Apr 2024 (actual)
Study completion: 14 May 2024 (actual)
First posted: 22 Nov 2024 (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.

For these reasons, non invasive stimulation techniques, namely transcutaneous stimulation by means of EXOPULSE Mollii suit, might be of help in this context.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: It is a randomized, controlled, double-blind, and cross-over study. Phase 1 is a randomized, controlled, double-blind, and cross-over study. In this phase, each participant will be randomly assigned to receive one session of active stimulation and one session of sham stimulation using the EXOPULSE Mollii suit (phase 1). The crossover design is appropriate for assessing symptomatic treatment of this chronic and relatively stable disease. Furthermore, the sessions will be separated by a wash-out interval of two weeks. Thus, a 2-week washout period should be enough to prevent a potential carry-over effect. At the end of phase 1 (two weeks after the second session of active or sham), an open-label phase (phase 2) will be proposed for all patients and will consist of 4 weeks of active stimulation (every other day stimulations for a total of 14 sessions). In total, each participant will be included in the study for 8 weeks (4 weeks for phase 1 and 4 weeks for phase 2).

Arm	Type	Receives
Experimental Condition	Active comparator	Device: EXOPULSE MOLLII SUIT (active)Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted. EXOPULSE Mollii Suit is used for the activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax.
Control Condition	Sham comparator	Device: EXOPULSE MOLLII SUIT (sham)In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
Age between 18 and 75 years.
Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) < 7).
Being free of relapses in the last three months.
Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).

Key exclusion criteria (10 listed)

Being included in another research protocol during the study period.
Inability to undergo medical monitoring for the study purposes due to geographical or social reasons.
Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit.
Being pregnant.
Having a change in their pharmacological therapy in the last three 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
EXOPULSE MOLLII SUIT (active)This study aims to evaluate the effects of the EXOPULSE Mollii suit, a non-invasive assistive device that delivers transcutaneous electrostimulation. The suit includes a CE-labeled class IIa control unit and class I body garments. Equipped with 58 electrodes, the full-body suit stimulates various muscle groups to reduce spasticity by activating antagonistic muscles through reciprocal inhibition, rather than causing muscle contractions. Designed to relax spastic muscles, improve range of motion, prevent atrophy, enhance circulation, and provide pain relief, the device is easy to use, requiring only one hour of daily wear, with effects lasting over 24 hours. Current treatments for spasticity, such as botulinum toxin and oral medications, have limitations like side effects and minimal mobility improvement. The EXOPULSE Mollii suit offers an innovative alternative, with early studies indicating positive impacts on mobility and motor function.	Device	Experimental Condition
EXOPULSE MOLLII SUIT (sham)In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.	Device	Control Condition

Primary outcome

Improvement in balance using the BBS (Berg Balance Scale) )
Time frame: BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)
Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in PwMS (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.

11 secondary outcomes

Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale) after 4 weeks of using Exopulse Molii Suit
Time frame: BBS evaluation will occur at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Assessment of the spasticity using the MAS (Modified Ashworth Scale)
Time frame: Spasticity according to MAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Assessment of the spasticity using the VAS spasticity (Visual Analogue Scale)
Time frame: VAS spasicity will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Mobility will be assessed using the TUG (Time Up and Go)
Time frame: Mobility according to TUG will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
Time frame: FES-I will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)
Time frame: MSWS-12 will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Quality of life will be measured using the MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire)
Time frame: MusiQOL will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Pain will be assessed using a VAS (Visual Analogue Scale)
Time frame: Pain according to VAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Fatigue will be assessed using a VAS (Visual Analogue Scale)
Time frame: Fatigue according to VAS be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
Evaluation of overall improvement using the CGI (Clinical Global Impression)
Time frame: CGI will be assessed at Day 1 (after the intervention, phase 1), at Day 15 (after the intervention, phase 1) and at Day 60 (at the end of phase 2)
Evaluation of patient's blinding to the type of stimulation in the crossover trial
Time frame: Blinding wil be assessed at Day 1 (after the intervention) and at Day 15 (after the intervention) during Phase 1.

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 18 Jun 2025.
Derived from this study: PubMed 40547078Ayache SS, Mattar JG, Creange A, Abdellaoui M, Zedet M, Lefaucheur JP, Megherbi H, Khaled H, Abi Lahoud GN, Chalah MA. The effect of the EXOPULSE Mollii suit on motor functions in patients with multiple sclerosis - a randomized sham-controlled crossover trial. Mult Scler J Exp Transl Clin. 2025 Jun 19;11(2):20552173251348304. doi: 10.1177/20552173251348304. eCollection 2025 Apr-Jun.

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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.

Samar S AYACHE, MD, PhD principal investigator

Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EXOPULSE MOLLII SUIT (active) in people with Multiple Sclerosis, run by Institut De La Colonne Vertebrale Et Des Neurosciences 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 7 inclusion and 10 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 18 Jun 2025. 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?

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?

Improvement in balance using the BBS (Berg Balance Scale) ) (time frame: BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)). 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 NCT06702137, 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 18 Jun 2025.