Multiple Sclerosis
Conditions
Keywords
Neurorehabilitation
Brief summary
The overall purpose of this project is to develop and test an infrastructure that can ensure early and specialized rehabilitation for individuals with multiple sclerosis (MS) on their path to recovery from a relapse. If this project proves successful, it can therefore help optimize clinical practice and provide a significant contribution to the treatment of relapsing-remitting sclerosis.
Interventions
BEHAVIORALIntensive rehab
Frequent moderate-to-high intensity physical therapy, provided by local physiotherapists.
BEHAVIORALUsual care
Usual care physiotherapy
Sponsors
Lars Hvid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* admitted to the Danish MS Hospitals for an inpatient rehabilitation stay * confirmed motor relapse (within the past 6 months) by a neurologist, with disability/ functional interference characterized by change in pyramidal, and/or cerebellar functional scores of 2 or higher * completed steroid or other acute relapse treatment, if prescribed * age over 18 years
Exclusion criteria
* more than 6 months since onset of motor relapse * medical conditions or substantial cognitive impairments that hinder participation in the study (e.g. inability to perform or understand the intensive rehabilitation) * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | Change from Baseline to 52 weeks | The Expanded Disability Status Scale measures your current level of disability. |
| MS Functional Composite (MSFC) Score | Change from Baseline to 52 weeks | A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six spot step test (SSST) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Measure of walking balance and coordination |
| Five times sit to stand chair rise test (5STS) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Measure of lower extremity function |
| Five times sit to stand chair rise test muscle power (5STS_power) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Measure of lower extremity muscle power |
| Patient determined disease steps (PDDS) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of mobility disability. |
| MS Walking Scale (MSWS) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of walking ability. |
| MS Functional Composite (MSFC) Score | Changes from Baseline to 2 weeks and 10 weeks | A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS). |
| Functional Assessment of MS (FAMS) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of how MS impacts quality of life. |
| Modified Fatigue Impact Scale (MFIS) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of fatigue. |
| Manual Ability Measurement (MAM36) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of hand function related to functional questions. |
| Treatment Satisfactory Questionnaire (TSQ) | Evaluated at 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of treatment satisfaction. |
| Multiple Sclerosis Cognitive Scale (MSCS) | Changes from baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of cognitive function. |
| Falls Efficacy Scale International (short FES-I) | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Patient-reported measure of concerns of falls (including history of falls). |
| Handgrip strength | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks | Maximal handgrip muscle strength of both sides. |
Countries
Denmark
Contacts
Primary ContactLars Hvid, PhD
Outcome results
None listed