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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive rehab | Experimental | 10 weeks of community-based physical therapy. Participants will receive two weekly supervised physical therapy session (45-60 minutes). The content of this exercise program and the specific exercises and exercise methods will be planned in collaboration between MS specialists from the Danish MS hospitals, the local physical therapist, and the participant. |
|
| Usual care | Active Comparator | 10 weeks of usual care physiotherapy, normally comprised of municipal rehabilitation as well as self-administered behavior. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive rehab | Behavioral | Frequent moderate-to-high intensity physical therapy, provided by local physiotherapists. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | The Expanded Disability Status Scale measures your current level of disability. | Change from Baseline to 52 weeks |
| MS Functional Composite (MSFC) Score | A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS). | Change from Baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MS Functional Composite (MSFC) Score | A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS). | Changes from Baseline to 2 weeks and 10 weeks |
| Handgrip strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Hvid, PhD | Contact | +4593508717 | larshv@sclerosehospital.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Danish MS Hospitals | Recruiting | Haslev | 7080 | Denmark |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Usual care | Behavioral | Usual care physiotherapy |
|
Maximal handgrip muscle strength of both sides.
| Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Six spot step test (SSST) | Measure of walking balance and coordination | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Five times sit to stand chair rise test (5STS) | Measure of lower extremity function | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Five times sit to stand chair rise test muscle power (5STS_power) | Measure of lower extremity muscle power | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Patient determined disease steps (PDDS) | Patient-reported measure of mobility disability. | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| MS Walking Scale (MSWS) | Patient-reported measure of walking ability. | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Falls Efficacy Scale International (short FES-I) | Patient-reported measure of concerns of falls (including history of falls). | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Functional Assessment of MS (FAMS) | Patient-reported measure of how MS impacts quality of life. | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Modified Fatigue Impact Scale (MFIS) | Patient-reported measure of fatigue. | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Manual Ability Measurement (MAM36) | Patient-reported measure of hand function related to functional questions. | Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks |
| Treatment Satisfactory Questionnaire (TSQ) | Patient-reported measure of treatment satisfaction. | Evaluated at 2 weeks, 10 weeks, and 52 weeks |
| Multiple Sclerosis Cognitive Scale (MSCS) | Patient-reported measure of cognitive function. | Changes from baseline to 2 weeks, 10 weeks, and 52 weeks |
| The Danish MS Hospitals | Recruiting | Ry | 7080 | Denmark |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |