Functional Intermuscular Reduction of Spasticity
MS-FIRST
1 other identifier
observational
16
1 country
1
Brief Summary
Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2021
CompletedSeptember 29, 2021
September 1, 2021
1.6 years
May 13, 2020
September 27, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
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.
Interventions
dry needling followed by functional electrical stimulation and treadmill training
Eligibility Criteria
People with a diagnosis of MS and spasticity
You may qualify if:
- Diagnosis of MS based on MRI
- Ability walk 25 feet
- Spasticity of one lower extremity
You may not qualify if:
- Blood clot within the last 6 months
- Bleeding disorder
- Active cancer
- Botox in the lower extremities within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- Oklahoma Medical Research Foundationcollaborator
Study Sites (1)
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shirley James, PhD
University of Oklahoma
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 27, 2020
Study Start
August 19, 2019
Primary Completion
April 1, 2021
Study Completion
April 18, 2021
Last Updated
September 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share