Functional Intermuscular Reduction of Spasticity

NCT ID: NCT04403594

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2021-04-18

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MS with spasticity of one lower extremity

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.

dry needling

Intervention Type: OTHER

dry needling followed by functional electrical stimulation and treadmill training

Interventions

dry needling

dry needling followed by functional electrical stimulation and treadmill training

Intervention Type: OTHER

Other Intervention Names

functional electrical stimulation

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of MS based on MRI

2. Ability walk 25 feet

3. Spasticity of one lower extremity

Exclusion Criteria

1. Blood clot within the last 6 months

2. Bleeding disorder

3. Active cancer

4. Botox in the lower extremities within 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oklahoma Medical Research Foundation

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirley James, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

19-21

Identifier Type: -

Identifier Source: org_study_id