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The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months.
For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2).
Statistical analyzes will be of two types:
Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Rehabilitation | Experimental | the first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net). |
|
| Combined Training | Experimental | the second group followed a mixed training program with the use of the version of the verbal memory module of the Rehacom program combined with the MR training. |
|
| Motor Rehabilitation | Experimental | the third group carried out a traditional MR training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Rehabilitation | Behavioral | Each patient performed two weekly sessions of 45 minutes each, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post treatment and long term cognitive efficiency | The primary outcome of this study is the scores on the cognitive tasks (Minimal Assessment of Cognitive Functioning in Multiple Sclerosis -MACFIMS). For MACFIMS score ranges from 1 to 3 with higher scores corresponding to higher cognitive impairment. | 9-months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post-treatment and long term motor efficiency | The secondary outcome of this study is the scores on the gait and balance efficiency scales (Tinetti Scale -TS); For TS the score ranges from 0 to 28 with higher scores corresponding to higher efficiency. | 9-months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post-treatment and long term disability and overall quality of life | Tertiary outcome is the scores on the self-perceived quality of life assessed with World Health Organization Disability Assessment Schedule- WHO-DAS 2. For WHO-DAS 2 total score ranges from 0 to 100, with lower scores indicate lower levels of disability e better quality of life. | 9-months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ugo Nocentini, MD | I.R.C.C.S. "Santa Lucia" Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Lucia Foundation I.R.C.C.S. | Roma | Rm | 00179 | Italy | ||
| I.R.C.C.S. "Santa Lucia" Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36542204 | Derived | Argento O, Piacentini C, Bossa M, Caltagirone C, Santamato A, Saraceni V, Nocentini U. Motor, cognitive, and combined rehabilitation approaches on MS patients' cognitive impairment. Neurol Sci. 2023 Mar;44(3):1109-1118. doi: 10.1007/s10072-022-06552-4. Epub 2022 Dec 21. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| 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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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Combined Rehabilitation | Behavioral | Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks. |
|
| Motor Rehabilitation | Behavioral | Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks. |
|
| Rome |
| 00149 |
| Italy |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |