Evaluation of a Spasticity Management Program for People with Multiple Sclerosis

NIH RePORTER · VA · I01 · · view on reporter.nih.gov ↗

Abstract

The purpose of this proposal is to evaluate a new multiple sclerosis (MS) spasticity education and stretching program called MS Spasticity: Take Control (STC) in a fully powered, randomized, controlled trial for benefit after one month (short-term) of home stretching practice and sustainability of benefit after six months (medium- term) of home stretching practice. Important first steps are complete: 1) the Spasticity and MS Clinical Practice Guideline has been developed; 2) the proposed PI has created a self-management program, STC, for MS- related spasticity that includes two DVDs MS Spasticity: Take Control (with educational information) and MS Spasticity: Take Control of Lower Extremity Stretching (with standardized stretching instructions) and companion reference manuals, and 3) the program has been tested in 40 subjects with MS and spasticity. STC demonstrated initial efficacy as well as feasibility, acceptance and rapid enrollment with satisfaction reported by participants. In the present study, eligible subjects in northwest Oregon and southwest Washington will be randomly assigned 1:1 to STC or usual care (UC). STC subjects will attend two in-person group sessions with the PI and the study coordinator to view and discuss information presented in both DVDs at the first session and practice all the stretches in the second session with the goal of finding a set of exercises for daily stretching for their home practice for the following six months. UC subjects will not attend classes but, instead, will be given a copy of the NMSS stretching brochure to use in their home practice without instruction or group support. The primary endpoint outcome measures will be collected after the classes for the STC group and one month of home practice. The same outcome measures will be collected after six months of home practice for the secondary endpoint when subjects will exit the study. Both groups will start their home practice within two weeks of each other, within two months of baseline data collection and be provided the same diaries to track their home stretching and other exercise participation. The primary outcome measure is the MS Spasticity Scale 88. Secondary outcome measures are the Numeric Rating Scale for Spasticity and the National Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) collection that specifically assess fatigue, sleep, physical function, self-efficacy, social participation, social satisfaction and perception of global health from their online collection of patient-reported health status inventories and outcome measures with the novel capability of administering computerized adaptive tests (CATs). CATs adapt to the individual by selecting subsequent questions based on participants’ prior responses reducing the length of the tests and therefore each test takes approximately one to two minutes to complete. The NIH recommends using these outcome measures to accelerate discovery by making s...

Key facts

NIH application ID
9836653
Project number
5I01RX002507-03
Recipient
PORTLAND VA MEDICAL CENTER
Principal Investigator
Lucinda L Hugos
Activity code
I01
Funding institute
VA
Fiscal year
2020
Award amount
Award type
5
Project period
2018-01-01 → 2021-12-31