Trial Outcomes & Findings for Clinic-Based AMES Treatment of Stroke (NCT NCT00847704)

Results Overview

Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Results posted on

2017-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group Device: Assisted movement and enhanced sensation
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Group Device: Assisted movement and enhanced sensation
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinic-Based AMES Treatment of Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=2 Participants Device: Assisted movement and enhanced sensation Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session. Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments.
Age, Continuous	67 years STANDARD_DEVIATION 2.0 • n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Time since stroke	113.5 Months STANDARD_DEVIATION 85.5 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.

Outcome measures

Outcome measures
Measure	Test Group n=2 Participants Group receiving AMES therapy
Fugl-Meyer Assessment of the Lower Extremity Baseline	21.0 units on a scale Standard Deviation 1.0
Fugl-Meyer Assessment of the Lower Extremity Post-treatment	19.5 units on a scale Standard Deviation 0.5
Fugl-Meyer Assessment of the Lower Extremity 3 Month Follow-up	21 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Gait Assessment - Time

Outcome measures

Outcome measures
Measure	Test Group n=2 Participants Group receiving AMES therapy
Timed 10-Meter Walk Post-treatment	13.66 seconds Standard Deviation 0.34
Timed 10-Meter Walk 3 Month Follow-up	13.27 seconds Standard Deviation 0.11
Timed 10-Meter Walk Baseline	12.465 seconds Standard Deviation 0.055

SECONDARY outcome

Timeframe: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows: Transformed Scale=\[(Actual raw score-lowest possible raw score)/Possible raw score range\]x100. Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.

Outcome measures

Outcome measures
Measure	Test Group n=2 Participants Group receiving AMES therapy
Stroke Impact Scale Baseline	234.5 units on a scale Standard Deviation 9.5
Stroke Impact Scale Post-treatment	258 units on a scale Standard Deviation 4.0
Stroke Impact Scale 3 Month Follow-up	251.5 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.

Outcome measures

Outcome measures
Measure	Test Group n=2 Participants Group receiving AMES therapy
Spasticity (Modified Ashworth) Scale Baseline	2.0 units on a scale Standard Deviation 2.0
Spasticity (Modified Ashworth) Scale Post-treatment	0.5 units on a scale Standard Deviation 0.5
Spasticity (Modified Ashworth) Scale 3 Month Follow-up	2.0 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).

Outcome measures

Outcome measures
Measure	Test Group n=2 Participants Group receiving AMES therapy
Strength Test Dorsiflexion	33.7 Newton meters Standard Deviation 41.4
Strength Test Plantarflexion	31.5 Newton meters Standard Deviation 8.8

SECONDARY outcome

Timeframe: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.

Outcome measures

Outcome measures
Measure	Test Group n=2 Participants Group receiving AMES therapy
Active Motion Test	5.8 Seconds Standard Deviation 0.2

Adverse Events

Test Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Treatment Group n=3 participants at risk Device: Subjects receiving AMES treatments.
Musculoskeletal and connective tissue disorders Fall	33.3% 1/3 • Number of events 1 • 1 year, 1 month Verbal inquiry at the beginning of each training session.

Additional Information

Paul J. Cordo

Oregon Health & Science University

Phone: 503-418-2520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place