An interventional study of MeCFES-assisted task-oriented upper limb rehabilitation and Usual Care task-oriented upper limb rehabilitation in Stroke, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 82 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation
Device: MeCFES-assisted task-oriented upper limb rehabilitation
25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
Other: Usual Care task-oriented upper limb rehabilitation
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.
Time frame: 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
Time frame: 5 weeks (post-treatment vs pre-treatment)
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.
Time frame: 5 weeks (post-treatment vs pre-treatment)
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.
Time frame: 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).
Time frame: 5 weeks (post-treatment vs pre-treatment)
| Milestone | MeCFES | Control |
|---|---|---|
| Started | 38 | 44 |
| Completed | 32 | 36 |
| Not completed | 6 | 8 |
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.
| score on a scale | MeCFES | Control |
|---|---|---|
| Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment | 6.6 ± 8.1 | 5.0 ± 7.3 |
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
| score on a scale | MeCFES | Control |
|---|---|---|
| Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment | 7.8 ± 9.0 | 4.5 ± 5.2 |
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.
| score on a scale | MeCFES | Control |
|---|---|---|
| Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment | -2.8 ± 5.6 | -3.2 ± 3.5 |
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.
| score on a scale | MeCFES | Control |
|---|---|---|
| Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment | -4.8 ± 9.4 | -7.4 ± 11.3 |
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).
| score on a scale | MeCFES | Control |
|---|---|---|
| Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment | 0 (-1 to 1) | 0 (-1 to 0) |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MeCFES | — | 0/32 (0%) | 0/32 (0%) |
| Control | — | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | MeCFES | Control | Total |
|---|---|---|---|
| Mean | 66.2 ± 12.9 | 67.1 ± 13.8 | 66.6 ± 13.3 |
| Sex: Female, Male(Participants) | MeCFES | Control | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 17 | 22 | 39 |
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Fondazione Don Carlo Gnocchi Onlus