Trial Outcomes & Findings for Functional Electrical Stimulation Use in Trans-tibial Amputations (NCT NCT02931396)

Last Updated: 2024-12-02

Results Overview

Residual limb knee extension isometric strength was tested using a standardized Biodex protocol and custom attachment. The lever arm of the Biodex was positioned at 60 degrees of knee flexion, with the support cushion modified for the amputee and positioned at the mid-tibia. The participant was asked to extend their knee against the arm as hard as they could for five seconds.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	FES Intervention Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home. FES	Control Participants will be asked to continue their activities of daily living as usual.
Overall Study STARTED	10	10
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	FES Intervention Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home. FES	Control Participants will be asked to continue their activities of daily living as usual.
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Functional Electrical Stimulation Use in Trans-tibial Amputations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FES Intervention n=10 Participants Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home. FES	Control n=10 Participants Participants will be asked to continue their activities of daily living as usual.	Total n=20 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 10.4 • n=5 Participants	49.9 years STANDARD_DEVIATION 16.8 • n=7 Participants	52.8 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Outcome measures
Measure	FES Intervention n=5 Participants Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home. FES	Control n=10 Participants Participants will be asked to continue their activities of daily living as usual.
Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System	-0.1 Nm/kg Interval -6.0 to 5.7	2.2 Nm/kg Interval -1.4 to 5.8

PRIMARY outcome

Timeframe: baseline and 12 weeks

3-D motion-tracking laser scanning system was used to determine residual limb volume in cm

Outcome measures

Outcome measures
Measure	FES Intervention n=5 Participants Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home. FES	Control n=10 Participants Participants will be asked to continue their activities of daily living as usual.
Change in Residual Limb Volume Using 3-D Scanner	-1.6 cm Interval -13.9 to 10.7	23.9 cm Interval -39.8 to 87.6

PRIMARY outcome

Timeframe: baseline and 12 weeks

Scores were reported on a 0 to 10 scale with higher scores representing higher pain levels

Outcome measures

Outcome measures
Measure	FES Intervention n=5 Participants Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home. FES	Control n=10 Participants Participants will be asked to continue their activities of daily living as usual.
Change in Residual Limb Pain Using Likert Scale Pain Questionnaire	-1.2 units on a scale Interval -2.8 to 0.4	1.5 units on a scale Interval -0.6 to 3.6

Adverse Events

FES Intervention

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

Alicia Koontz

University of Pittsburgh

Phone: 4128223700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place