Functional Intermuscular Reduction of Spasticity

Study Overview
=================
Brief Summary
-----------------
Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation.

Detailed Description
-----------------
This study will be the first to combine a novel two-pronged approach to the management of spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease spasticity in an innovative way through dry needling. Second, investigators will follow this spasticity reduction technique using external electrical stimulation applied to the calf, while the participant walks on a harnessed treadmill (for safety). The investigators believe modulating tone in the calf with dry needling will allow for improved strength with electrical stimulation, while simultaneously improving the efficiency of the muscles during walking. The investigators hypothesize that decreasing spasticity will result in enhanced gait efficiency, and lower fatigue, all while allowing the participant to meet their personal mobility goals.10 The investigators are proposing an innovative study design. Assessing changes in muscle spasticity using electromyography and the Modified Ashworth scale before and after each portion of our two-pronged intervention will enable them to understand the immediate effects of dry needling, as well as the combined effects of function electrical stimulation with with treadmill training. Following the intervention assessments with pre-post functional tests will allow us to determine long term changes. This proposal offers a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with the advantage of being minimally invasive and inexpensive. Results of this pilot study will inform the potential use in MS, and will allow for a larger study examining optimal intervention parameters for future use.

Official Title
-----------------
Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: dry needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MS based on MRI Ability walk 25 feet Spasticity of one lower extremity Exclusion Criteria: Blood clot within the last 6 months Bleeding disorder Active cancer Botox in the lower extremities within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MS with spasticity of one lower extremity<br>A person diagnosed with Multiple Sclerosis and spasticty of one lower extremity. The person must be able to walk 25 feet and cannot have had Botox in the lower extremity on the last 6 months. | Other: dry needling<br>* dry needling followed by functional electrical stimulation and treadmill training<br>* Other names: functional electrical stimulation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test | distance walked over 6 minutes assessed at the start of the study and after 6 weeks. | up to 7 weeks | 
| 25-foot walk | time to walk 25 feet assessed at the start of the study and after 6 weeks. | up to 7 weeks | 
| Berg Balance Scale | Balance test conducted at the start of the study and after 6 weeks. | up to 7 weeks | 
| Modified Fatigue Impact Scale | patient-reported questionnaire collected at the start of the study and after 6 weeks. | up to 7 weeks | 
| Toe taps on force plate | number of toe taps in 10 seconds counted at the start of the study and after 6 weeks. | up to 7 weeks | 
| EMG data of both lower extremities | Electromyography (EMG) will be conducted at the start of the study and after 6 weeks. EMG is an electrodiagnostic technique for evaluating and recording the electrical activity produced by skeletal muscles. This is completed using electrodes that are placed on the skin, which detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. These action potentials are measured and recorded on a computer. | up to 7 weeks |