Trial Outcomes & Findings for Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008 (NCT NCT00864708)

NCT ID: NCT00864708

Last Updated: 2014-05-26

Results Overview

The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: Day 1 and at 3 months, following treatment
• Results posted on: 2014-05-26

Participant Flow

Dec 2008 - October 2009, recruitment by flier and by word of mouth

Participant milestones

Measure	Arm 1 Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Baseline characteristics by cohort

Measure	Arm 1 n=1 Participants Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and at 3 months, following treatment

The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.

Outcome measures

Measure	Arm 1 n=1 Participants gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Walking Endurance (6MWT) Day 1-6MWT	843 feet
Walking Endurance (6MWT) After 3 months of treatment- 6MWT	771 feet

PRIMARY outcome

Timeframe: Day 1 and at 3 months, following treatment

assessment of the lower limb kinematics during ambulation at chosen speed.

Outcome measures

Measure	Arm 1 n=1 Participants gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Kinematic Gait Measures	0 percentage of change Day 1 to 3 months

SECONDARY outcome

Timeframe: Day 1 and at 3 months, following treatment

Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).

Outcome measures

Measure	Arm 1 n=1 Participants gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Fugl-Meyer Lower Extremity Score Day 1- Fugl Meyer Score	22 units on a scale
Fugl-Meyer Lower Extremity Score After 3 months of treatment- Fugl Meyer Score	26 units on a scale

SECONDARY outcome

Timeframe: Day 1 and at 3 months, following treatment

The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)

Outcome measures

Measure	Arm 1 n=1 Participants gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Ashworth Scale Day 1-Ashworth Score	1.5 units on a scale
Ashworth Scale After 3 months of treatment- Ashworth Score	1.0 units on a scale

SECONDARY outcome

Timeframe: Day 1 and at 3 months, following treatment

The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).

Outcome measures

Measure	Arm 1 n=1 Participants gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Stroke Impact Scale (SIS) Day 1-SIS	261 units on a scale
Stroke Impact Scale (SIS) After 3 months of treatment- SIS	264 units on a scale

SECONDARY outcome

Timeframe: Day 1 and at 3 months, following treatment

This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)

Outcome measures

Measure	Arm 1 n=1 Participants gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Manual Muscle Testing (MMT) Day 1-MMT	21.35 units on a scale
Manual Muscle Testing (MMT) After 3 months of treatment- MMT	23.33 units on a scale

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1 n=1 participants at risk Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
Musculoskeletal and connective tissue disorders delivery of unactivated stimuli (within comfort)	100.0% 1/1 • Number of events 1

Additional Information

Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence

NF/SG VA Medical Center, Gainesville Florida

Phone: (352) 376-1611

Email: janis.daly@neurology.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators are employed by the Department of Veterans Affairs (DVA) which funded the study; the Alfred P. Mann Foundation (AMF) provided the technology that was tested. There was an agreement between the Principal Investigators of the DVA and the AMF that the AMF would be provided a period of time to review any manuscript for publication and provide input. There was no restriction regarding PI's rights to discuss or publish the results.
• Publication restrictions are in place

Restriction type: OTHER