Evaluation of a Spasticity Management Program for People With Multiple
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Spasticity Take Control
Compared with
- Stretching for People with MS: An Illustrated Manual
Results by group
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
One month post-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Spasticity Take Control | -16.11 units on a scale | 34.14 (Standard Deviation) | 105 |
| Stretching for People With MS: An Illustrated Manual | -15.83 units on a scale | 37.33 (Standard Deviation) | 105 |
Spasticity Take Control
Stretching for People With MS: An Illustrated Manual
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Six months post-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Spasticity Take Control | -23.25 units on a scale | 38.96 (Standard Deviation) | 97 |
| Stretching for People With MS: An Illustrated Manual | -24.11 units on a scale | 41.2 (Standard Deviation) | 97 |
Spasticity Take Control
Stretching for People With MS: An Illustrated Manual
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Spasticity Take Control | 116 | 4 (3.4%) | 0 |
| Stretching for People With MS: An Illustrated Manual | 115 | 3 (2.6%) | 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
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
One month post-intervention
SpasticityImpact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Six months post-intervention
Spasticity
Other measures (8)
Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity
One month post-intervention
SpasticityFatigue, Measured by the Modified Fatigue Impact Scale
One month post-intervention
FatigueSleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index
One month post-intervention
Mood and sleepPsychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
One month post-intervention
Quality of life (reported by participants)PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
One month post-intervention
Mood and sleepImpact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12
One month post-intervention
Walking and mobilityWalking Measured by the Timed 25 Foot Walk
One month post-intervention
Disability progressionWalking and mobilityWalking and Turning Measured by the Timed Up and Go
One month post-intervention
Walking and mobility
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jan 2018
Main results due
Jul 2021
Finished
Jan 2022
Results posted
Mar 2026