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| Name | Class |
|---|---|
| Istituto Di Ricerche Farmacologiche Mario Negri | OTHER |
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Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MeCFES | Experimental | 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation |
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| Control | Active Comparator | 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeCFES-assisted task-oriented upper limb rehabilitation | Device |
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| Usual Care task-oriented upper limb rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment | ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome. | 5 weeks (post-treatment vs pre-treatment) |
| Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment | FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome | 5 weeks (post-treatment vs pre-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment | IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000). IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome. | 5 weeks (post-treatment vs pre-treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Ferrarin, PhD | Fondazione Don Carlo Gnocchi ETS | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12392340 | Background | van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa. | |
| 1135616 | Background | Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MeCFES | 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Other |
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| Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment |
DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome. |
| 5 weeks (post-treatment vs pre-treatment) |
| Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment | VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain). | 5 weeks (post-treatment vs pre-treatment) |
| Background | Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15 |
| Background | Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011. |
25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
Usual Care task-oriented upper limb rehabilitation
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MeCFES | 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation |
| BG001 | Control | 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment | ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks (post-treatment vs pre-treatment) |
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| Primary | Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment | FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome | Posted | Mean | Standard Deviation | score on a scale | 5 weeks (post-treatment vs pre-treatment) |
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| Secondary | Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment | IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000). IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome. | 3 patients (1 belonging to MeCFES group and 2 to Control group) did not attend the post-treatment IPPA evaluation, thus they were excluded from this analysis. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks (post-treatment vs pre-treatment) |
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| Secondary | Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment | DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome. | 2 patients (both belonging to Control group) did not attend the post-treatment DASH evaluation, thus they were excluded from this analysis. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks (post-treatment vs pre-treatment) |
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| Secondary | Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment | VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain). | Posted | Median | Inter-Quartile Range | score on a scale | 5 weeks (post-treatment vs pre-treatment) |
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5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MeCFES | 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation | 0 | 32 | 0 | 32 | ||
| EG001 | Control | 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation | 0 | 36 | 0 | 36 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maurizio Ferrarin | Fondazione Don Carlo Gnocchi | +390240308305 | mferrarin@dongnocchi.it |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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