Developing and Testing a Comprehensive MS Spasticity Management Progra
Developing and Testing a Comprehensive MS Spasticity Management Program
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| MS Walking Scale-12 (MSWS-12) | 0.84 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Spasticity: Take Control
- Usual care
Results by group
MS Walking Scale-12 (MSWS-12)
at average of 4 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| A Spasticity: Take Control | 72.6 units on a scale | 27.3 (Standard Deviation) | 19 |
| B Usual Care | 82.2 units on a scale | 30.8 (Standard Deviation) | 19 |
A Spasticity: Take Control
B Usual Care
p = 0.84
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| A Spasticity: Take Control | 19 | 0 (0.0%) | |
| B Usual Care | 19 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
MS Walking Scale-12 (MSWS-12)
at average of 4 months
Walking and mobility
Other measures (8)
Timed 25 Foot Walk
at average of 4 months
Disability progressionWalking and mobilityTimed up and go Test
at average of 4 months
Walking and mobility2 Minute Walk Test
at average of 4 months
Walking and mobilityModified Fatigue Impact Scale (MFIS)
at average of 4 months
FatigueMultiple Sclerosis Impact Scale (MSIS-29)
at average of 4 months
Quality of life (reported by participants)Spasticity Measured by the Modified Ashworth Scale
at average of 4 months
SpasticityMultiple Sclerosis Spasticity Scale - 88 (MSSS-88)
at average of 4 months
SpasticityBeck Depression Inventory II (BDI II)
at average of 4 months
Mood and sleep
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
Diagnosis of definite MS * At least 18 years old * Able to walk 25 feet independently with common assistive devices if needed * Presence of spasticity by self-report interfering with usual daily activities * Have an email account and be familiar with using it * Willing to track daily exercise for 4 weeks * Fluent in English
Exclusion criteria
Other medical or behavioral conditions that would limit participation or completion of the study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.
Papers
Loading reviews and guidelines…
History
Started
Oct 2015
Main results due
May 2016
Finished
Jun 2016
Results posted
Mar 2017