Trial Outcomes & Findings for Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients (NCT NCT03019744)

NCT ID: NCT03019744

Last Updated: 2018-10-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

5 weeks (post-treatment vs pre-treatment)

Results posted on

2018-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	MeCFES 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation
Overall Study STARTED	38	44
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MeCFES n=38 Participants 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control n=44 Participants 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation	Total n=82 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 12.9 • n=5 Participants	67.1 years STANDARD_DEVIATION 13.8 • n=7 Participants	66.6 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks (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.

Outcome measures

Outcome measures
Measure	MeCFES n=32 Participants 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control n=36 Participants 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation
Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment	6.6 score on a scale Standard Deviation 8.1	5.0 score on a scale Standard Deviation 7.3

PRIMARY outcome

Timeframe: 5 weeks (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

Outcome measures

Outcome measures
Measure	MeCFES n=32 Participants 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control n=36 Participants 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation
Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment	7.8 score on a scale Standard Deviation 9.0	4.5 score on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 5 weeks (post-treatment vs pre-treatment)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MeCFES n=31 Participants 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control n=34 Participants 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation
Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment	-2.8 score on a scale Standard Deviation 5.6	-3.2 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 5 weeks (post-treatment vs pre-treatment)

Population: 2 patients (both belonging to Control group) did not attend the post-treatment DASH evaluation, thus they were excluded from this analysis.

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.

Outcome measures

Outcome measures
Measure	MeCFES n=32 Participants 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control n=34 Participants 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation
Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment	-4.8 score on a scale Standard Deviation 9.4	-7.4 score on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: 5 weeks (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).

Outcome measures

Outcome measures
Measure	MeCFES n=32 Participants 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	Control n=36 Participants 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation
Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment	0 score on a scale Interval -1.0 to 1.0	0 score on a scale Interval -1.0 to 0.0

Adverse Events

MeCFES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Maurizio Ferrarin

Fondazione Don Carlo Gnocchi

Phone: +390240308305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place