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| Name | Class |
|---|---|
| Otto Bock Healthcare Products GmbH | INDUSTRY |
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The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.
Optimization Aim: Identify a systematic, methodological approach to device fitting, inclinic and at-home protocols using the Mollii suit, and optimization of collecting outcome measures at assessment visits. For example, up to 15 participants will complete a portion or all of the procedures listed in the "Procedures Involved" section of this protocol to determine an optimal approach.
Aim 1: Assess the safety of the Mollii suit during an in-clinic or at-home 12-week period consisting of daily sessions of a 60-minute duration in individuals with pain and/or spasticity from neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.
Aim 2: Evaluate the use of full-body active electrostimulation as compared to full-body sham electrostimulation as an intervention in-clinic or at-home for individuals experiencing pain and/or spasticity due to neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running. |
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| Sham | Sham Comparator | Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active full-body stimulation | Device | Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Manual Muscle Test | A procedure to evaluate the strength of individual muscles relative to gravity and manual resistance. Scores can range from 0 (no contraction) to 5 (full contraction against max resistance) | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
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Inclusion Criteria:
Age 18 to 75 years old
Medical clearance from physician
Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia
For participants with a diagnosis of Multiple Sclerosis:
For participants with a diagnosis of Fibromyalgia:
a. having a definite diagnosis for at least three months
Able to follow instructions and inform study staff of pain and/or discomfort
Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arun Jayaraman, PhD | Contact | 312-238-6875 | ajayaraman@sralab.org | |
| Sara Prokup, DPT | Contact | 312-238-1355 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Recruiting | Chicago | Illinois | 60611 | United States |
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| Sham full-body stimulation | Other | Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups. |
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| Modified Ashworth Scale | The Modified Ashworth Scale is used to grade the amount of hypertonicity / spasticity in individuals. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. Scores can range from 0 (no spasticity) to 4 (affected part rigid.) | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| 10 Meter Walk Test | Participants are timed as they walk 10 meters at both their self-selected speed, and their fastest but safest speeds. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| 6 Minute Walk Test | A test to measure the distance that a participant can walk over a period of 6 minutes. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| Timed Up and Go | The Timed Up and Go measures the time it takes for a person to stand up from a chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| Twelve-Item Multiple Sclerosis Walking Scale | A self-report questionnaire that measures the impact of multiple sclerosis on a person's walking ability. Scores range from 12 - 60, with higher scores indicating a greater impact on walking ability. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| Falls Efficacy Scale | A questionnaire that measures a participant's fear of falling for items related to activities of daily living. Scores range from 10 - 100, with higher scores indicating an increased fear of falling. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| Multiple Sclerosis International Quality of Life Questionnaire | A multi-dimensional questionnaire about a patient's quality of life for those who have multiple sclerosis. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| Clinical Global Impressions Scale | A assessment of the clinician's view of a participant's global functioning prior to, and after initiating a study intervention. | Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005356 | Fibromyalgia |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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