Clinic-Based AMES Treatment of Stroke

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Cerebrovascular Accident
Stroke

Treatments

Device: Assisted movement and enhanced sensation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00847704
IRB 4005

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Test treatment group
Experimental group
Description:
Device: Assisted movement and enhanced sensation
Treatment:
Device: Assisted movement and enhanced sensation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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