Trial Outcomes & Findings for Proprioception Testing in Persons With Sensorimotor Impairment (NCT NCT01974635)

NCT ID: NCT01974635

Last Updated: 2019-06-13

Results Overview

Testing proprioceptive sensation, the subject, with eyes closed, attempts to identify verbally the direction of motion (i.e., flexion or extension) as the AMES device randomly moves the subject's thumb and fingers, or the whole hand, into flexion and extension.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Immediately after each treatment on the AMES Device

Results posted on

2019-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	AMES Therapy The AMES device rotates the hand into flexion and extension, while the participant assists with this motion and receives visual feedback of the motion. At the same time, the AMES device vibrates the muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so. This study provides for 25 AMES training sessions over 8-13 weeks.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proprioception Testing in Persons With Sensorimotor Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMES Therapy n=2 Participants The AMES device rotates the hand into flexion and extension, while the participant assists with this motion and receives visual feedback of the motion. At the same time, the AMES device vibrates the muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so. This study provides for 25 AMES training sessions over 8-13 weeks. At the end of the intervention, the participant's proprioception (i.e., sense of joint position and movement) is tested by asking the participant, with eyes closed, to blink as the fingers and thumb or the wrist are rotated through a prescribed joint angle (i.e., target angle) by the AMES device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.5 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after each treatment on the AMES Device

Population: Device used for eye-blinks did not perform as expected. Study terminated prior to any further analyses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After each treatment on the AMES device.

Population: Eye-blink response device didn't perform as expected. Study terminated before any analysis performed.

Testing proprioceptive sensation, the AMES device moves the subject's wrist through a 30 degree range, at variable speeds, as the subject attempts to identify when their wrist reaches a particular target, either by opening contact between the thumb and index finger (if possible) or blinking the eyes. The subject receives feedback about the accuracy of the testing.

Outcome measures

Outcome data not reported

Adverse Events

AMES Therapy and Diagnostic

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMES Therapy and Diagnostic n=2 participants at risk AMES therapy: During treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week. AMES Diagnostic: Either at baseline and 10-13 weeks later, or immediately following each therapy session, the participant performs a number of diagnostic tests to determine his/her level of proprioceptive perception.
Injury, poisoning and procedural complications Fall	50.0% 1/2 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Paul Cordo

AMES Technology Inc.

Phone: 15039706129

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place