Clinic-Based AMES Treatment of Stroke

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00847704
• Collaborator: AMES Technology (Industry)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Cerebrovascular Accident	Device: Assisted movement and enhanced sensation	Phase 1/Phase 2

Detailed Description

The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test treatment group Device: Assisted movement and enhanced sensation	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Assessment of the Lower Extremity [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.

Secondary Outcome Measures

1. Timed 10-Meter Walk [Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up]

   Gait Assessment - Time

2. Stroke Impact Scale [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.

3. Spasticity (Modified Ashworth) Scale [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.

4. Strength Test [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).

5. Active Motion Test [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 12 months post-stroke

• Cognitively and behaviorally capable of complying with the regimen

• Functioning proprioception

• Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices

Exclusion Criteria:

• Fractures of treated limb resulting in loss of range of motion

• Spinal cord injury

• Deep vein thrombosis

• Peripheral nerve injury or neuropathy in the limb affected with motor disability

• Osteoarthritis limiting range of motion

• Skin condition not tolerant of device

• Progressive neurodegenerative disorder

• Uncontrolled seizure disorder

• Botox treatment within the last 5 months

• Baclofen pump

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• AMES Technology

Investigators

• Principal Investigator: Paul J. Cordo, PhD, AMES Technology Inc./Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Neurorehabilitation and Neural Repair Volume 23(1), 2009

Publications

• Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.

• Responsible Party: Paul J. Cordo, Principal Investigator, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00847704
• Other Study ID Numbers: IRB 4005; NCT00600184
• First Posted: Feb 19, 2009
• Last Update Posted: Jan 23, 2017
• Last Verified: Nov 1, 2016

• Keywords provided by Paul J. Cordo, Principal Investigator, Oregon Health and Science University: Stroke; Rehabilitation; Robotics
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Test Group
Arm/Group Description	Device: Assisted movement and enhanced sensation
Period Title: Overall Study
STARTED	3
COMPLETED	2
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Test Group
Arm/Group Description	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.
Overall Participants	2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (2.0)
Gender (Count of Participants)
Female	1 50%
Male	1 50%
Region of Enrollment (participants) [Number]
United States	2 100%
Time since stroke (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	113.5 (85.5)

Outcome Measures

1. Primary Outcome

Title	Fugl-Meyer Assessment of the Lower Extremity
Description	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.
Time Frame	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Group
Arm/Group Description	Group receiving AMES therapy
Measure Participants	2
Baseline	21.0 (1.0)
Post-treatment	19.5 (0.5)
3 Month Follow-up	21 (1.0)

2. Secondary Outcome

Title	Timed 10-Meter Walk
Description	Gait Assessment - Time
Time Frame	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Group
Arm/Group Description	Group receiving AMES therapy
Measure Participants	2
Baseline	12.465 (0.055)
Post-treatment	13.66 (0.34)
3 Month Follow-up	13.27 (0.11)

3. Secondary Outcome

Title	Stroke Impact Scale
Description	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.
Time Frame	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Group
Arm/Group Description	Group receiving AMES therapy
Measure Participants	2
Baseline	234.5 (9.5)
Post-treatment	258 (4.0)
3 Month Follow-up	251.5 (1.5)

4. Secondary Outcome

Title	Spasticity (Modified Ashworth) Scale
Description	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.
Time Frame	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Group
Arm/Group Description	Group receiving AMES therapy
Measure Participants	2
Baseline	2.0 (2.0)
Post-treatment	0.5 (0.5)
3 Month Follow-up	2.0 (1.0)

5. Secondary Outcome

Title	Strength Test
Description	Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).
Time Frame	First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Group
Arm/Group Description	Group receiving AMES therapy
Measure Participants	2
Dorsiflexion	33.7 (41.4)
Plantarflexion	31.5 (8.8)

6. Secondary Outcome

Title	Active Motion Test
Description	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.
Time Frame	First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Group
Arm/Group Description	Group receiving AMES therapy
Measure Participants	2
Mean (Standard Deviation) [Seconds]	5.8 (0.2)

Adverse Events

Time Frame	1 year, 1 month
Adverse Event Reporting Description	Verbal inquiry at the beginning of each training session.
Arm/Group Title	Test Treatment Group
Arm/Group Description	Device: Subjects receiving AMES treatments.
All Cause Mortality
	Test Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Test Treatment Group
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Test Treatment Group
	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)
Musculoskeletal and connective tissue disorders
Fall	1/3 (33.3%)	1

Limitations/Caveats

Early termination due to lack of funding lead to only 2 subjects treated and analyzed.

More Information

Certain Agreements

All Principal Investigators ARE 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.