Trial Outcomes & Findings for Evaluation of Dual Channel vs. Single Channel FES for Dropfoot (NCT NCT02494323)

Results Overview

Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

7 months

Results posted on

2016-08-03

Participant Flow

Recruitment occurred between 01May to 03Dec2015. Subjects were recruited through Bet-Loweinstein Head Trauma Rehabilitation Department and through Bioness Ltd Clinic Clinic.

Participant milestones

Participant milestones
Measure	Functional Electrical Stimulation Dual channel stimulation of the peroneal nerve to improve dropfoot Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Dual Channel vs. Single Channel FES for Dropfoot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Functional Electrical Stimulation n=70 Participants Dual channel stimulation of the peroneal nerve to improve dropfoot Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=99 Participants
Age, Categorical >=65 years	30 Participants n=99 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 14.83 • n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	48 Participants n=99 Participants
Region of Enrollment Israel	70 participants n=99 Participants

PRIMARY outcome

Timeframe: 7 months

Population: All subjects suffer from foot drop due to upper motor neuron lesion

Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.

Outcome measures

Outcome measures
Measure	Functional Electrical Stimulation n=70 Participants Dual channel stimulation of the peroneal nerve to improve dropfoot Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot
Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE	3.63 units on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: 7 months

Population: Five subjects were excluded from filling up the BSW questionnaire, since the Segmented Electrode (SE) did not produce motor reaction in the ankle

Number of subjects who benefited or not benefited from the dual channel electrode was counted, number of patients who were satisfied or not satisfied with the dual channel electrode was counted, number of subjects who were willing to continue or who were unwilling to continue with the dual channel electrode was counted

Outcome measures

Outcome measures
Measure	Functional Electrical Stimulation n=65 Participants Dual channel stimulation of the peroneal nerve to improve dropfoot Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot
Benefit Satisfaction Willingness to Continue (BSW) Questionnaire had benefit from SE	50 participants
Benefit Satisfaction Willingness to Continue (BSW) Questionnaire were satisfied with the SE	55 participants
Benefit Satisfaction Willingness to Continue (BSW) Questionnaire had no benefit from SE	15 participants
Benefit Satisfaction Willingness to Continue (BSW) Questionnaire were not satisfied with the SE	10 participants
Benefit Satisfaction Willingness to Continue (BSW) Questionnaire were willing to continue with the SE	47 participants
Benefit Satisfaction Willingness to Continue (BSW) Questionnaire were not willing to continue with the SE	18 participants

Adverse Events

Functional Electrical Stimulation

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.Yaron Sacher

Bet-Loewenstein

Phone: 97297709918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60