Recruiting

Myoelectric Orthosis

Sponsor:

Myomo

Code:

NCT02544672

Conditions

Cerebrovascular Accidents

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Myoelectric Elbow-Wrist-Hand orthosis

Study Details

Brief summary:

The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).

Conditions

Cerebrovascular Accidents

Study ID

NCT02544672

Start date

Jul, 2015

Status verified date

Sep, 2015

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults over 18 years.
  • Upper limb impairment caused by any stroke (CVA)
  • Minimum of trace MMT (1/5) in Biceps and/or Triceps
  • Full Passive range of motion in elbow, forearm, wrist, and hand
  • Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
  • Score of at least 20 on the Mini Mental Status Examination.
  • Ability to read and comprehend the English language.
  • Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.

Exclusion Criteria:

  • Fixed upper limb contractures on affected side.
  • Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
  • Inability to follow three step directions.
  • Severe shoulder subluxation, pain or shoulder dislocation.
  • Passive shoulder range of motion less than 45 degrees in flexion and abduction.
  • Pain or hypersensitivity in the arm(s)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Interventions and Outcome Measures

Arms

experimental: Myoelectric Elbow-Wrist-Hand Orthosis

Interventions

Myoelectric Elbow-Wrist-Hand orthosis

An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.

Primary outcome measure

  • Fugl-Meyer Assessment Upper Extremity (FMA-UE) [ Time Frame: 2 hours ]
  • Modified Ashworth Scale [ Time Frame: 2 hours ]
  • Box and Blocks Test [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Jonathan Naft, CPO, LPO

440-285-5785jnaft@greop.com

Locations

GRE Chardon

Recruiting

Chardon, Ohio, United States, 44024

Contacts

Jonathan Naft, CPO, LPO

440-285-5785jnaft@greop.com

More Information

Sponsor

Myomo

Last update posted

Sep 9, 2015

Last verified

Sep, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Myomo on 2015-09-09.