Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— STC  

Official title:

Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166930
• Other study ID #: B2507-R
• Secondary ID: I01RX002507
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.

Description:

Now online since COVID-19

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: January 31, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of definite MS by 2010 updated McDonald Criteria
• Age 18 or older
• Able to walk 25 feet with any assistive devices (Patient Determined Disease Steps 0-6)
• Fluent in written and spoken English, as materials are not validated in languages other than English.
• Presence of self-reported lower extremity spasticity that is interfering with daily activities or sleep, using the this definition: Have spasticity in your legs with unusual tightening of muscles that feels like leg stiffness, jumping of the legs, a repetitive bouncing of the foot, muscle cramping in the legs, or the legs going out tight and straight or drawing up.
• All women that meet the above criteria
• Only Veteran men that meet the above criteria

Exclusion Criteria:

• Any uncontrolled medical or mental condition that would limit participation or completion of the study
• Any self-reported musculoskeletal or neurological condition other than MS that is known to cause spasticity

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis

Intervention

Behavioral:
• Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
• Stretching for People with MS: An Illustrated Manual
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88	Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention.	One month post-intervention
Secondary	Severity of spasticity, measured by the Numeric Rating Scale for Spasticity	Severity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention.	One month post-intervention
Secondary	Fatigue, measured by the Modified Fatigue Impact Scale	Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention.	One month post-intervention
Secondary	Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index	Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention.	One month post-intervention
Secondary	Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29	Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention.	One month post-intervention
Secondary	PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a	Emotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention.	One month post-intervention
Secondary	Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12	Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention.	One month post-intervention
Secondary	Walking measured by the Timed 25 Foot Walk	Walking will be measured using the Timed 25 Foot Walk at one month post intervention, only if visit is in person.	One month post-intervention
Secondary	Walking and turning measured by the Timed Up and Go	Walking and turning measured by the Timed Up and Go will be measured at one month post intervention, only if visit is in person.	One month post-intervention