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| Name | Class |
|---|---|
| NeuFit - Neurological Fitness and Education | INDUSTRY |
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In an individual with MS the central nervous system (CNS) is over-protective and causes the threshold for stretch reflex and muscle tightness to be set lower than normal. This inhibits normal movement and causes abnormalities in posture, stiffness and at times joint contractures. In this pilot study we hope to assess the ability for the direct current of Neubie, which creates mechanoreceptor inputs and lengthening at the sarcomere level of muscle and joints in the spine and lower extremity, to alter the proprioceptive peripheral nervous system (PNS) at muscle spindle and GTO level with a change in CNS over-guarding during the treatment and after the treatment. If the investigators are able to create normalized stretch and muscle tension at the PNS level, it may be possible to create temporary or sustained CNS level changes. This would allow the amount of stretch and tension at the PNS level to be normalized and possibly reduce spasticity. If this theory is accurate, the investigators may be able to increase access to normalized movement, strength and functional ability in individuals with neuro-compromise.
Approximately 66%6 to 84% of individuals with multiple sclerosis experience various levels of debilitating spasticity limiting freedom of movement at ankles, knees and hips causing deficits in ambulation, weakness from disuse of muscles not accessible due to spasticity. Per the North American Research Committee on Multiple Sclerosis, a survey was conducted on spasticity prevalence and results show 84% have some degree of spasticity from mild to incapacitating. Spasticity pathophysiology is complex and not completely understood with higher levels of incapacitating spasticity reported in this survey by those who were male, disabled and unemployed, indicating that psychosocial and subjective variables are significant. The pathophysiology currently best understood demonstrates an imbalance between inhibitory dorsal reticulospinal tract (RST) fibers and excitatory bulbopontine tegmentum. RST neurons receive direct somatic, vestibular, tectal, cerebellar and motor excitatory input and are scattered in the ventral and lateral spinal cord columns intermingled with propriospinal fibers. The peripheral Golgi tendon organ of muscle tendon and muscle spindle intrafusal fibers ubiquitous throughout the musculoskeletal system have direct monosynaptic connection to these central nervous system propriospinal fibers and heavily influence the degree of spasticity and overactive stretch reflexes.
Those who deal with all levels of spasticity use compensatory movement strategies causing altered arthrokinematics and have loss of strength, balance and efficient muscle use with postural changes. Spasticity management has been studied and treated from a pharmaceutical standpoint with some improvements but often side effects including fatigue, muscle weakness and cognition limit dosing in oral Baclofen, Dantrolene Sodium, Tizanidine and Benzodiazepines. Marijuana especially in form of cannabinoids shows mixed evidence for spasticity improvement and is a growing area of interest. There is a growing CBD interest in the MS population due to known reduction of CNS neurodegeneration in animal MS studies and no significant negative side effects with possible mild to moderate improvement in spasticity levels. Therapy interventions offered include frequent stretching especially of muscles that cross two joints including lumbricals, hamstrings, gastrocnemius and iliopsoas; light stroking over lower limbs demonstrated a 30% decrease in H-reflex amplitude lasting even 30 minutes after treatment; muscle cooling was shown to reduce muscle stretch activity and clonus; Armutlu et al. Reported significant reduction in plantar flexor spasticity in 10 patients with MS using high-frequency (100Hz) TENS for 20min daily for 4 weeks. Reduction noted on Modified Ashworth Scale (MAS), electrophysiologic measurements and the AI; and serial casting performed over a 9-day period with cast changes every 3 days demonstrated reduced spasticity levels.
The NeuFit company offers a Neubie EMS product with a direct current using high fidelity audio equipment to decrease intensity of the treatment noxious stimulus and protect skin integrity from burns or intolerable pain. This system uses an exponential wave pattern to mimic the natural pattern neurologically to lengthen fibers of the sarcomere and engage force velocity of muscle with minimized protective co-contraction of nearby muscle groups9. The golgi tendon and muscle spindles code for joint position and muscle/tendon stretch with 66% of fibers being intrafusal. Impacting these structures has direct impact on reticulospinal tract (RST) fibers and proprioceptive central fibers modulation of levels of spasticity. However, finding effective means to impact these areas is difficult. The Neubie direct current is designed to improve positioning of these stretch receptors. As discussed within the paper hypothesis, the theory is that this may improve spasticity levels as well as agonist strength enough to create long term, significant functional improvement.
Dr. Terry Wahls who has MS and has studied and marketed a protocol for MS treatment, promotes this product and has a home unit she uses daily to control her own MS symptoms and gain strength. Currently there is no research study conducted on the effects of the Neubie direct current treatment combined with exercise and ramifications of spasticity in multiple sclerosis. There have been only a few studies conducted with quantitative spasticity measures mostly with FES and NMES targeting tibialis anterior and quadriceps to lessen plantar flexor spasticity in spinal cord injury (SCI) and hemiplegia. In the SCI study Mirbagheri et al. observed decreases in intrinsic and reflex dynamic stiffness in all 4 subjects studied over a 16-month period. Robinson et al. stimulated quadriceps muscle pulse duration 500, 20 Hz and amplitude of 100 with spasticity quantitatively reduced immediately after stimulation but return of baseline spasticity level when measured 24 hours later. Levin and Hui-Chan assessed sensory level stimulation of the common peroneal nerve for a total of 15, 60 min sessions for 3 weeks in people with hemiplegia using pulse duration 125 continuously at 99Hz and observed inhibition of H-reflex at soleus, increase in dorsiflexion voluntary force and reductions in stretch reflex at triceps surae. The NeuFit method of treatment allows the recipient to voluntarily concentrically or eccentrically activate muscles while receiving the direct current passive eccentric input. In order to assess the feasibility of this papers' hypothesis the investigators will perform a pilot study of 4-6 individuals with MS in the greater Denver metro area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neubie Treatment | Experimental | Participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neubie | Device | The Neubie is a direct current neuromuscular electrical stimulation device. This system uses an exponential wave pattern to mimic the natural pattern neurologically to lengthen fibers of the sarcomere and engage force velocity of muscle with minimized protective co-contraction of nearby muscle groups. The golgi tendon and muscle spindles code for joint position and muscle/tendon stretch with 66% of fibers being intrafusal. Impacting these structures has direct impact on reticulospinal tract fibers and proprioceptive central fibers modulation of levels of spasticity. The Neubie direct current is designed to improve positioning of these stretch receptors. |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Score | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment. | Baseline, Pre-intervention |
| Expanded Disability Status Score | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment. | 6 weeks |
| 12 Item MS Walking Scale | The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. | Baseline, Pre-intervention |
| 12 Item MS Walking Scale | The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Ellerbusch, DPT | CommonSpirit Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centura Health at Home | Littleton | Colorado | 80027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28603459 | Background | Backus D, Burdett B, Hawkins L, Manella C, McCully KK, Sweatman M. Outcomes After Functional Electrical Stimulation Cycle Training in Individuals with Multiple Sclerosis Who Are Nonambulatory. Int J MS Care. 2017 May-Jun;19(3):113-121. doi: 10.7224/1537-2073.2015-036. | |
| 29794531 | Background | Etoom M, Khraiwesh Y, Lena F, Hawamdeh M, Hawamdeh Z, Centonze D, Foti C. Effectiveness of Physiotherapy Interventions on Spasticity in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2018 Nov;97(11):793-807. doi: 10.1097/PHM.0000000000000970. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neubie Treatment | Outcome measures will be collected at the beginning and end of study.
Neubie: The Neubie is a direct current neuromuscular electrical stimulation device. This system uses an exponential wave pattern to mimic the natural pattern neurologically to lengthen fibers of the sarcomere and engage force velocity of muscle with minimized protective co-contraction of nearby muscle groups. The golgi tendon and muscle spindles code for joint position and muscle/tendon stretch with 66% of fibers being intrafusal. Impacting these structures has direct impact on reticulospinal tract fibers and proprioceptive central fibers modulation of levels of spasticity. The Neubie direct current is designed to improve positioning of these stretch receptors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neubie Treatment | All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Expanded Disability Status Score | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment. | Posted | Median | Standard Deviation | score on a scale | Baseline, Pre-intervention |
|
1 day
Adverse event collection match the clinicaltrials.gov definitions and procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NeuBie Treatment | The 7 subjects with Multiple Sclerosis participating in this clinical trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | ClinicalTrial Vocab | Non-systematic Assessment | The patient presented with fatigue and symptoms suggestive of urinary tract infection which limited her capacity to tolerate the study required ambulatory testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney Ellerbusch | Centura Health | 3039058272 | courtneyellerbusch@centura.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2022 | Aug 9, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2022 | Aug 9, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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This will be a pilot study using a series of 4-6 case studies for 4-6 participants. All studies will be completed entirely from the subject's home with CSHRI IRB oversight.
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|
| 6 weeks |
| Manual Muscle Test | A standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials. | Baseline, Pre-intervention |
| Manual Muscle Test | A standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials. | 3 week measurement |
| Manual Muscle Test | A standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials. | 6 weeks |
| Timed 25 Foot Walk Test (T25FW) | The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25 foot walk. | Baseline, Pre-intervention |
| Multiple Sclerosis Impact Scale (MSIS-29) | The Multiple sclerosis impact scale 29 (MSIS-29) is a 29-item assessment combining questions about the physical and psychological impact of the participant's condition on daily living. All items have Likert style response options that go from 1 (not at all) to 5 (extremely), where a total score of 145 indicates greater impact of disease on daily function (worse health), and the lower the score (The closer it is to 29), the smaller the impact of multiple sclerosis on the participant's daily function. | baseline, pre-intervention |
| Timed 25 Foot Walk Test (T25FW) | The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25-foot walk measured in seconds. Higher second measures are slower and considered "worse" while lower second measures are faster and considered "better". | 3 week |
| Timed 25 Foot Walk Test (T25FW) | The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25-foot walk measured in seconds. Higher second measures are slower and considered "worse" while lower second measures are faster and considered "better". | 6 week |
| Multiple Sclerosis Impact Scale (MSIS-29) | The Multiple sclerosis impact scale 29 (MSIS-29) is a 29-item assessment combining questions about the physical and psychological impact of the participant's condition on daily living. All items have Likert style response options that go from 1 (not at all) to 5 (extremely), where a total score of 145 indicates greater impact of disease on daily function (worse health), and the lower the score (The closer it is to 29), the smaller the impact of multiple sclerosis on the participant's daily function. | 6 week |
| Modified Ashworth Test | The Modified Ashworth Test is measured on a 5-point scale used to assess spasticity by grading the resistance encountered during passive muscle stretching. The assessor rates the perceived amount of resistance or tone encountered during the range of motion. 0=no tone detected 1+ = tone able to move through for less than half the range 2=tone able to move through for more than half the range 3=significant resistance to movement for entire range but able to break tone 4=completely rigid and unable to move limb | Baseline, pre-intervention |
| Modified Ashworth Test | The Modified Ashworth Test is measured on a 5-point scale used to assess spasticity by grading the resistance encountered during passive muscle stretching. The assessor rates the perceived amount of resistance or tone encountered during the range of motion. 0=no tone detected 1+ = tone able to move through for less than half the range 2=tone able to move through for more than half the range 3=significant resistance to movement for entire range but able to break tone 4=completely rigid and unable to move limb | 6 week |
| 21138391 | Background | Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080. |
| 19565162 | Background | Szecsi J, Schlick C, Schiller M, Pollmann W, Koenig N, Straube A. Functional electrical stimulation-assisted cycling of patients with multiple sclerosis: biomechanical and functional outcome--a pilot study. J Rehabil Med. 2009 Jul;41(8):674-80. doi: 10.2340/16501977-0397. |
| 26829077 | Background | Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437. |
| 28901119 | Background | Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R. Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Aug;54(4):576-590. doi: 10.23736/S1973-9087.17.04796-7. Epub 2017 Sep 13. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Expanded Disability Status Score | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Primary | 12 Item MS Walking Scale | The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. | Posted | Mean | Standard Deviation | percentage of a score on a scale | Baseline, Pre-intervention |
|
|
|
| Primary | 12 Item MS Walking Scale | The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. | Posted | Mean | Standard Deviation | percentage of a score on a scale | 6 weeks |
|
|
|
| Primary | Manual Muscle Test | A standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Pre-intervention |
|
|
|
| Primary | Manual Muscle Test | A standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials. | Posted | Mean | Standard Deviation | units on a scale | 3 week measurement |
|
|
|
| Primary | Manual Muscle Test | A standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Primary | Timed 25 Foot Walk Test (T25FW) | The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25 foot walk. | Posted | Mean | Standard Deviation | units on a scale (seconds) | Baseline, Pre-intervention |
|
|
|
| Primary | Multiple Sclerosis Impact Scale (MSIS-29) | The Multiple sclerosis impact scale 29 (MSIS-29) is a 29-item assessment combining questions about the physical and psychological impact of the participant's condition on daily living. All items have Likert style response options that go from 1 (not at all) to 5 (extremely), where a total score of 145 indicates greater impact of disease on daily function (worse health), and the lower the score (The closer it is to 29), the smaller the impact of multiple sclerosis on the participant's daily function. | Posted | Mean | Standard Deviation | percentage of a score on a scale | baseline, pre-intervention |
|
|
|
| Primary | Timed 25 Foot Walk Test (T25FW) | The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25-foot walk measured in seconds. Higher second measures are slower and considered "worse" while lower second measures are faster and considered "better". | Posted | Mean | Standard Deviation | seconds | 3 week |
|
|
|
| Primary | Timed 25 Foot Walk Test (T25FW) | The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25-foot walk measured in seconds. Higher second measures are slower and considered "worse" while lower second measures are faster and considered "better". | Posted | Mean | Standard Deviation | seconds | 6 week |
|
|
|
| Primary | Multiple Sclerosis Impact Scale (MSIS-29) | The Multiple sclerosis impact scale 29 (MSIS-29) is a 29-item assessment combining questions about the physical and psychological impact of the participant's condition on daily living. All items have Likert style response options that go from 1 (not at all) to 5 (extremely), where a total score of 145 indicates greater impact of disease on daily function (worse health), and the lower the score (The closer it is to 29), the smaller the impact of multiple sclerosis on the participant's daily function. | Posted | Mean | Standard Deviation | percentage of a score on a scale | 6 week |
|
|
|
| Primary | Modified Ashworth Test | The Modified Ashworth Test is measured on a 5-point scale used to assess spasticity by grading the resistance encountered during passive muscle stretching. The assessor rates the perceived amount of resistance or tone encountered during the range of motion. 0=no tone detected 1+ = tone able to move through for less than half the range 2=tone able to move through for more than half the range 3=significant resistance to movement for entire range but able to break tone 4=completely rigid and unable to move limb | Posted | Mean | Standard Deviation | units on a scale | Baseline, pre-intervention |
|
|
|
| Primary | Modified Ashworth Test | The Modified Ashworth Test is measured on a 5-point scale used to assess spasticity by grading the resistance encountered during passive muscle stretching. The assessor rates the perceived amount of resistance or tone encountered during the range of motion. 0=no tone detected 1+ = tone able to move through for less than half the range 2=tone able to move through for more than half the range 3=significant resistance to movement for entire range but able to break tone 4=completely rigid and unable to move limb | Posted | Mean | Standard Deviation | units on a scale | 6 week |
|
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|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| quadratus lumborum right |
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| quadratus lumborum left |
|
| rectus femoris right |
|
| rectus femoris left |
|
| vastus lateralis and medialis right |
|
| vastus lateralis and medialis left |
|
| gluteus medius right |
|
| gluteus medius left |
|
| adductor group right |
|
| adductor group left |
|
| tibialis anterior right |
|
| tibialis anterior left |
|
| fibularii right |
|
| fibularii left |
|
| lumbar extension |
|
| gluteus maximus right |
|
| gluteus maximus left |
|
| Title | Measurements |
|---|---|
|
| quadratus lumborum right |
|
| quadratus lumborum left |
|
| rectus femoris right |
|
| rectus femoris left |
|
| vastus lateralis and vastus medialis left |
|
| vastus lateralis and vastus medialis right |
|
| gluteus medius right |
|
| gluteus medius left |
|
| adductor group right |
|
| adductor group left |
|
| tibialis anterior right |
|
| tibialis anterior left |
|
| fibularis right |
|
| fibularis left |
|
| lumbar extension |
|
| gluteus maximus right |
|
| gluteus maxiums left |
|
| Title | Measurements |
|---|---|
|
| rectus femoris left |
|
| gluteus maxiumus left |
|
| biceps femoris right |
|
| gluteus maximus right |
|
| psoas left |
|
| biceps femoris left |
|
| tibialis anterior right |
|
| quadratus lumborum left |
|
| gluteus medius left |
|
| gluteus medius right |
|
| quadratus lumborum right |
|
| tibialis anterior left |
|
| vastus lateralis/medialis right |
|
| hip adductor group right |
|
| lumbar extension bilateral |
|
| vastus lateralis/medialis left |
|
| hip adductor group left |
|
| Title | Measurements |
|---|---|
|
| ankle plantarflexion right |
|
| knee extension right |
|
| ankle plantarflexion left |
|
| hip extension left |
|
| hip flexion left |
|
| knee flexion left |
|
| hip extension right |
|
| hip flexion right |
|
| knee flexion right |
|
| Title | Measurements |
|---|---|
|
| ankle plantarflexion right |
|
| knee extension right |
|
| ankle plantarflexion left |
|
| hip extension left |
|
| hip flexion left |
|
| knee flexion left |
|
| hip extension right |
|
| hip flexion right |
|
| knee flexion right |
|