AMES Treatment of the Impaired Leg in Chronic Stroke Patients

NCT01378637 | Unknown Phase 1 DMC

• 2 other identifiers: 7034R44NS060192-03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).

Conditions

Stroke; Cerebrovascular Accident; Hemiparesis

Keywords

Leg; Robotic device; AMES; Stroke; Cerebrovascular Accident; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Motor Assessment of the Lower Affected Extremity

  Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments

Secondary Outcomes (6)

• Gait Assessment

  Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments

• Modified Ashworth Scale

  Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments

• Dynamic Balance/Weight Distribution

  Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments

• Ankle Strength

  Prior to each treatment session,

• Passive Motion Test

  Prior to each treatment session

Study Arms (1)

AMES Leg treatment

EXPERIMENTAL

An investigational device flexes and extends the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the foot. The subject's task is to assist the motion of the device by pulling or pushing with the foot. Feedback of ankle torque or the electrical signal produced by the muscles (EMG) while the subject is assisting the motion is provided during the 30 treatment sessions.

Device: AMES- Leg treatment

Interventions

AMES- Leg treatment DEVICE

30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible.

AMES Leg treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spastic hemiparesis
• At least 12 months post-stroke
• Can comfortably fit foot in treatment device
• Functioning proprioception
• Fugl-Meyer LE score \>6 and \<23
• Minimal hemi-neglect
• Observable volitional movement of the ankle in either plantar- or dorsi-flexion
• Cognitively and behaviorally capable of complying with the regimen

You may not qualify if:

• Fractures of treated limb resulting in loss of range of motion
• Spinal cord injury
• Deep venous thrombosis
• Peripheral nerve injury or neuropathy in the affected limb with motor disability
• Osteoarthritis limiting range of motion
• Uncontrolled high blood pressure/angina
• Exercise intolerant
• Skin condition not tolerant of device
• Progressive neurodegenerative disorder
• Uncontrolled seizure disorder
• Botox treatment within last 5 months
• Baclofen pump

Sponsors & Collaborators

• AMES Technology: lead
• Oregon Health and Science University: collaborator
• Northwestern University: collaborator
• Shirley Ryan AbilityLab: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Northwestern University/Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Oregon Health and Science University

Portland, Oregon, 97006, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Oken, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Elliot Roth, MD

  Northwestern University/Rehabilitation Institute of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: June 22, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)