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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mollii Group | Experimental | Receaving treatment with the stimulation program. |
|
| Control Group | Placebo Comparator | Receaving treatment without the stimulation program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the Mollii garment with active stimulation | Other | Patients in the Intervention group attend therapy three days a week for four weeks, with each treatment lasting 60 minutes. In this group patients are fitted with the Mollii garment according to the same protocol, but in their case, active stimulation of the prescribed neuromodulation program is initiated. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is. | 4 weeks |
| Barthel Index (BI) | Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale (SIS) | Physical and psychological functions after stroke scaling 0-100 points, higher score means better post-stroke functions. | 4 weeks |
| Multiple Sclerosis Impact Scale (MSIS-29) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Kopácsi | Contact | +36308340545 | kbarbi0108@gmail.com | |
| József Dr. habil. Tollár | Contact | +36306994497 | tollarjozsef86@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| József Dr. habil Tollár | Somogy County Kaposi Mór Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Somogy County Kaposi Mór Teaching Hospital | Recruiting | Kaposvár | Somogy County | 7400 | Hungary |
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| Mollii neuromodulation garment, but the stimulation program is not activated (placebo) | Other | CG patients are fully equipped with the Mollii neuromodulation garment, but the stimulation program is not activated. The patient thus completes the therapy without the device's perceptible electrical stimulation, preserving the blinding effect of the placebo-controlled setup. The total treatment time, setup process, and therapeutic environment are the same as for the intervention group. |
|
Physical and psychological effects in MS, scaling 0-100 points, where higher scores mean greater disease impact.
| 4 weeks |
| Berg Balance Scale (BBS) | Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance. | 4 weeks |
| Tinetti | Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk. | 4 weeks |
| Timed Up and Go (TUG) | Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling. | 4 weeks |
| 6 minute walk test (6MWT) | Functional exercise capacity | 4 weeks |
| 10 meter walk test (10mWT) | Walking speed | 4 weeks |
| Posturographic examination | Postural instability | 4 weeks |
| 3D motion analysis | Movement dynamics, gait | 4 weeks |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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