Treatment of Chronic Stroke With AMES + EMG Biofeedback

• Sponsor: AMES Technology (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01116544
• Collaborator: Oregon Health and Science University (Other), Emory University (Other), Northwestern University (Other)
• Enrollment: 46
• Locations: 3
• Arms: 2
• Actual Duration (Months): 41.3
• Patients Per Site: 15.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Plegia; Paresis; Cerebrovascular Accident	Device: AMES Therapy (assisted movement and enhanced sensation)	N/A

Detailed Description

Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology. However, the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients. A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies. The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Chronic Stroke With AMES + EMG Biofeedback
• Actual Study Start Date: Sep 21, 2007
• Actual Primary Completion Date: Feb 28, 2011
• Actual Study Completion Date: Feb 28, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMES therapy with EMG biofeedback The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. This study will examine whether AMES therapy combined with EMG biofeedback can restore hand opening to plegic stroke subjects.	Device: AMES Therapy (assisted movement and enhanced sensation); Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.; Other Names: Robotic
Experimental: AMES therapy with Torque biofeedback The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of torque (force) the subject is able to generate in the hand during the movement. This study will examine whether AMES therapy combined with Torque biofeedback can restore hand opening to plegic stroke subjects.	Device: AMES Therapy (assisted movement and enhanced sensation); Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.; Other Names: Robotic

Outcome Measures

Primary Outcome Measures

1. Box and Blocks Test [Within a week of completing all training sessions.]

   Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.

Secondary Outcome Measures

1. Fugl-Meyer (UL) Assessment [At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.]

   Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.

2. Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) [Within a week of completing all training sessions.]

   Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions [scored from 1 (least impact) to 5 (most impact)]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed: [(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range] X 100. The minimum transformed score is 0 and the maximum is 100.

3. Stroke Impact Scale (Stroke Recovery) [Within a week of completing all training sessions.]

   A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.

4. Strength Test Flexion [At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.]

   Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.

5. Strength Test Extension [At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.]

   Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual upper extremity weakness.

• Chronic stroke, occurring ≥12 months prior to subject enrollment.

• Age 18-80 years old.

• Inability to move any of the fingers of the affected hand more than 5.0 cm into extension.

• Finger-and-wrist impedance ≤3 on the Modified Ashworth Scale.

• Measureable EMG (>2 x baseline) in the long finger extensor muscle during attempted hand opening or closing.

• Physically and cognitively capable of consenting to and complying with the protocol (based on exam by Study Physician).

• Subject must be physically capable of communicating informed consent or must be accompanied by legally authorized representative to provide informed consent.

Exclusion Criteria:

• Complete flaccidity of the affected arm.

• Significant upper extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement with eyes closed).

• Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or resulting in pain in the arm.

• Spinal cord injury, arthritis, or fractures of affected arm that have resulted in loss of range of motion.

• Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the tested arm.

• Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance.

• Major active psychiatric disorder.

• Cognitively or behaviorally unable to follow instructions including severe apraxia; inability to understand verbal (English) directions, or inability to communicate adequately with study personnel.

• Size of arm incompatible with the AMES device (checked by placing the limb in the device).

• Severe contractures or decreased range of motion or skin condition that would prohibit comfortable positioning or tolerance of the device or the vibrators.

• Any progressive neurodegenerative disorder affecting the upper extremity motor system.

• Uncontrolled seizure disorder.

• Current abuse of alcohol or drugs.

• Terminal illness with anticipated survival of <12 months.

• Current or planned concurrent participation in another study involving therapy to the impaired arm

• Planned initiation of or cessation of any kind of clinical therapy to the impaired limb just prior to or during the AMES treatment period.

• NIH Stroke Scale, following scores: Sensory Item score of >1; Neglect involving the affected limb score >1.

• Intent to receive Botox injections (5 months prior to or during enrollment), initiation of antispasmodic medication, or use of any other robotic (e.g., MANUS, Locomat) or electrical or vibratory stimulation device (e.g., Bioness) while participating in the AMES trial.

• Cognitively or behaviorally unable to follow instructions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University School of Medicine	Atlanta	Georgia	United States	30322
2	Northwestern University	Chicago	Illinois	United States	60611
3	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• AMES Technology
• Oregon Health and Science University
• Emory University
• Northwestern University

Investigators

• Study Director: Paul J. Cordo, PhD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AMES Technology
• ClinicalTrials.gov Identifier: NCT01116544
• Other Study ID Numbers: CT NS060192
• First Posted: May 5, 2010
• Last Update Posted: Nov 18, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by AMES Technology: AMES device; Cerebrovascular Accident; Chronic Stroke; Rehabilitation; Upper Extremity; Biofeedback
• Additional relevant MeSH terms: Stroke; Paresis

Study Results

Participant Flow

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Period Title: Overall Study
STARTED	23	23
COMPLETED	21	22
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback	Total
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	Total of all reporting groups
Overall Participants	21	22	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (13)	45 (15)	46 (14)
Sex: Female, Male (Count of Participants)
Female	10 47.6%	12 54.5%	22 51.2%
Male	11 52.4%	10 45.5%	21 48.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 9.1%	2 4.7%
Not Hispanic or Latino	20 95.2%	20 90.9%	40 93%
Unknown or Not Reported	1 4.8%	0 0%	1 2.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 9.5%	1 4.5%	3 7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 57.1%	10 45.5%	22 51.2%
White	7 33.3%	11 50%	18 41.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Fugl-Meyer Assessment-Upper Limb (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	19.4 (6.2)	23.1 (8.8)	21.3 (7.8)
Strength Test Flexion (Newton-meters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Newton-meters]	16.6	18.0	17.6
Strength Test Extension (Newton-meters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Newton-meters]	-4.4	0.4	-0.9
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	51.0 (9.1)	53.6 (17.0)	52.3 (9.1)
Stroke Impact Scale (Stroke Recovery) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.0 (23.3)	48.0 (23.3)	46.0 (23.1)
Box-and-Block Test (Blocks moved) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Blocks moved]	0.0	0.0	0.0

Outcome Measures

1. Primary Outcome

Title	Box and Blocks Test
Description	Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.
Time Frame	Within a week of completing all training sessions.

Outcome Measure Data

Analysis Population Description

Chronic stroke with severe hand impairment

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Measure Participants	21	22
Median (Inter-Quartile Range) [Number of blocks moved]	0.0	0.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMES Therapy With EMG Biofeedback, AMES Therapy With Torque Biofeedback
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.005
	Comments	A priori threshold = 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Fugl-Meyer (UL) Assessment
Description	Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.
Time Frame	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.

Outcome Measure Data

Analysis Population Description

Chronic stroke with severe upper limb impairment

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Measure Participants	21	22
Mean (Standard Deviation) [units on a scale]	23.7 (6.2)	27.0 (10.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMES Therapy With EMG Biofeedback, AMES Therapy With Torque Biofeedback
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Hypothesis: significant increase in score (post-tx - pre-tx) for both groups
	Method	ANCOVA
	Comments	FMA scores adjusted for baseline differences.

3. Secondary Outcome

Title	Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
Description	Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions [scored from 1 (least impact) to 5 (most impact)]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed: [(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range] X 100. The minimum transformed score is 0 and the maximum is 100.
Time Frame	Within a week of completing all training sessions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Measure Participants	21	22
Mean (Standard Deviation) [units on a scale]	54.0 (8.1)	57.4 (18.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMES Therapy With EMG Biofeedback, AMES Therapy With Torque Biofeedback
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	Across both groups, whether score increased following completion of intervention
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Stroke Impact Scale (Stroke Recovery)
Description	A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.
Time Frame	Within a week of completing all training sessions.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Measure Participants	21	22
Mean (Standard Deviation) [units on a scale]	58.3 (18.2)	63.3 (17.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMES Therapy With EMG Biofeedback, AMES Therapy With Torque Biofeedback
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	Across both treatment groups
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Strength Test Flexion
Description	Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Time Frame	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Measure Participants	21	22
Median (Inter-Quartile Range) [Newton-meters]	21.2	30.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMES Therapy With EMG Biofeedback, AMES Therapy With Torque Biofeedback
	Comments	Data combined between 2 treatment groups
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Strength Test Extension
Description	Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Time Frame	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AMES Therapy With EMG Biofeedback	AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
Measure Participants	21	22
Median (Inter-Quartile Range) [Newton-meters]	-11.4	0.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMES Therapy With EMG Biofeedback, AMES Therapy With Torque Biofeedback
	Comments	Both treatment groups combined
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	2 years, 7 months
Adverse Event Reporting Description	Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
Arm/Group Title	AMES Therapy With EMG Biofeedback		AMES Therapy With Torque Biofeedback
Arm/Group Description	The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.		The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
All Cause Mortality
	AMES Therapy With EMG Biofeedback		AMES Therapy With Torque Biofeedback
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AMES Therapy With EMG Biofeedback		AMES Therapy With Torque Biofeedback
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/23 (13%)		0/23 (0%)
Cardiac disorders
Flu-like symptoms, high blood pressure	1/23 (4.3%)	1	0/23 (0%)	0
Eye disorders
Scratched cornea	1/23 (4.3%)	1	0/23 (0%)	0
Musculoskeletal and connective tissue disorders
Hip fracture	1/23 (4.3%)	1	0/23 (0%)	0
Other (Not Including Serious) Adverse Events
	AMES Therapy With EMG Biofeedback		AMES Therapy With Torque Biofeedback
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/23 (26.1%)		8/23 (34.8%)
Musculoskeletal and connective tissue disorders
Fall	3/23 (13%)	5	2/23 (8.7%)	2
Muscle soreness/fatigue	1/23 (4.3%)	1	2/23 (8.7%)	2
Hand pain	0/23 (0%)	0	2/23 (8.7%)	2
Nervous system disorders
Seizure	2/23 (8.7%)	2	0/23 (0%)	0
Skin and subcutaneous tissue disorders
Skin abrasion	1/23 (4.3%)	3	2/23 (8.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.