" Treating MS Patients With Lower Extremity Spasticity Using Dysport"

Browse trials for

• Muscle Spasticity 704
• Multiple Sclerosis 3,460
• Sclerosis 3,124

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Lead sponsor

Neurology Center of New England P.C. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Eligibility criteria

Interventions

• BiologicalAbobotulinumtoxin A

  Treating Patients with Multiple Sclerosis with lower extremity spasticity using Dysport (Abobotulinumtoxin A)

  Also known as: Dysport

Primary outcomes

1. Using Dysport to treat lower extremity spasticty in patients diagnosed with Multiple Sclerosis. Improved walking ability and quality of life in 28 patients based on quality of life assessments and patient reported outcomes.

   Using Dysport® (abobotulinumtoxin A) to treat patients diagnosed with Multiple Sclerosis with lower extremity spasticity .

   Time frame: 20 weeks

Secondary outcomes

1. Mean change from baseline in Modified Ashworth Scale (MAS)

   Mean change from baseline in Modified Ashworth Scale (MAS).. The Modified Ashworth Scale issued to grade spasticity. This scale measures the presence of velocity-dependent resistance on a 0 to 4 scale, with zero representing normal muscle tone, and four representing a limb that is fixed in flexion or extension

   Time frame: Baseline week 12, week 16, and week 20

Other outcomes

1. 12 item Multiple Sclerosis Walking scale (MSWS-12) Improvement

   Mean change from baseline in the 12 Item Multiple Sclerosis 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 during the past 2 weeks. 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

   Time frame: Baseline weeks 12, 16, and 20

2. Improvement of (MSIS-29) Multiple Sclerosis Impact Scale

   Mean change from baseline in the (MISIS-29) Multiple Sclerosis Impact Scale.The MSIS-29 is a 29 item measurement, which assesses the physical and psychological impact of MS on affected individuals; it is a self report questionnaire consisting of 20 and 9 items, respectively. Scores on the individual items are added and then transformed to a 0-100 scale, thereby generating two summary scores (for physical and psychological impact). Higher scores indicate worse health.

   Time frame: Baseline weeks 12,16 and 20

3. Improvement of Pain Scale

   Mean change from baseline in the 0-10 Pain Scale. involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. 0 Pain free 1. Very minor annoyance-occasional minor twinges 2. Minor annoyance-occasional 3. Annoying enough to be distracting 4. Can be ignored if you are really involved in your work, but still distracting, 5. Can't be ignored for more than 30 minutes. 6. Can't be ignored for any length of time, but you can still go to work and participate in social activities. 7. Make it difficult to concentrate, interferes with sleep, you can still function with effort 8. Physical activity severely limited. You can read and converse with effort. Nausea and dizziness may occur. 9. Unable to speak, crying out or moaning uncontrollable- pain makes you pass out 10. Unconscious. Pain makes you pass out.

   Time frame: Baseline weeks 12,16 and 20

4. Improvement of (MSSS-88) Multiple Sclerosis Spasticity Scale

   Mean Change from baseline in the (MSSS-88) Multiple sclerosis Spasticity scale measures patient experience and perception of the impact of spasticity in MS with day-to-day symptoms andduring functional activities over the previous two weeks. It has 88 questions to quantify spasticity for a total score and in eight clinically relevant and stand-alone subscales: muscle stiffness, pain and discomfort,muscle spasms, activities of daily living,walking, body movements, emotional health, and social functioning.This scale has 88 items that are rated on a 4-point scale of 1 (Not at all bothered) through 4 (Extremely bothered).

   Time frame: Baseline weeks 12,16 and 20

5. Improvement of the Penn Spasm frequency scale

   Mean change from baseline in the Penn Spasm frequency scale. The patient evaluates his/her "spasms", quantifying them according to 5 classifications (from 0 to 4).For ratings of 1 or greater, the severity of the spasms is also be evaluated, using a 3 level scale (mild, moderate or severe)

   Time frame: Baseline weeks 12,16 and 20

6. Improvement from baseline on the Timed 25 foot walk (T25FW)

   Mean change from baseline on the Timed 25 foot walk (T25FW) The Timed 25-Foot Walk test is a mobility and function test based on a timed 25-foot walk. An individual will be asked to walk 25 feet on a clearly marked course as quickly and safely as they can. The time is calculated with a stopwatch, recorded, and the individual is asked to repeat the task immediately, walking back the same distance to the their initial starting point.

   Time frame: Baseline weeks 12,16 and 20

7. Improvement of Timed up and Go

   Mean change from baseline on the Timed up and go. The purpose of the Timed Up and Go test is to identify individuals who are at risk of falling. It can screen for balance and gait problems. A person is observed as they stand from a sitting position without using their arms for support, then walk 10 feet, turn and return to a chair. Finally, they sit back in the chair without using their arms for support.

   Time frame: Baseline weeks 12,16 and 20

8. Improvement on the (EDSS) score

   Mean change from baseline on the Expanded Disability Status Scale (EDSS) score. is a 20 point ordinal scale ranging from 0 (normal neurological exam) to 10 (dead from MS). From 0-4.0, EDSS is determined by the combination of scores on 7 functional systems. From 4.0-6.0 EDSS is determined by the ability to walk a distance. EDSS 6.0 is the need for unilateral walking assistance. EDSS 6.5 is the need for bilateral walking assistance. Nonambulatory patients are scored EDSS ≥7.0, with higher number reflecting increasing difficulty with mobility and ability to perform self-care.

   Time frame: Baseline weeks 12,16 and 20

9. Walking improvement

   Change from baseline in speed, cadence, general symmetry, propulsion, stride length using the G-Walk device is a wireless system of inertial sensors composed of a triaxial accelerometer, a magnetic sensor, and a triaxial gyroscope that, when positioned on L5 vertebrae of the spine, it allows for a functional objective gait analysis to be performed. The system extrapolates the data and calculates all the spatial-temporal gait parameters required to perform an assessment or to define a training strategy

   Time frame: Baseline weeks 12,16 and week 20

Individual participant data

Plan to share: Undecided — Poster and Paper with at AAN and ECTRIMS intention for full manuscript