Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke

NCT03215771 | Completed Results FDA Device

• 1 other identifier: W81XWH-16-1-0733
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Longitudinal observation allowed the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators planned to recruit 15 Veterans and non-veterans who had TBI or stroke and upper limb impairment. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.

Conditions

Traumatic Brain Injury; Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA)

  Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.

  Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18

Secondary Outcomes (4)

• Modified Ashworth Scale

  Change in Modified Ashworth Scale from Baseline at Week 18

• Chedoke Arm and Hand Activity Inventory (CAHAI)

  Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18

• Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)

  Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18

• Craig Handicap Assessment and Rehabilitation Technique (CHART)

  Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18

Study Arms (1)

MyoPro + Motor Learning-Based Therapy

EXPERIMENTAL

Subjects received 9 weeks of motor learning-based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program.

Device: MyoPro Motion-G; Other: Motor Learning-Based Therapy

Interventions

MyoPro Motion-G DEVICE

The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.

MyoPro + Motor Learning-Based Therapy

Motor Learning-Based Therapy OTHER

Motor learning-based (MLB) therapy included movement practice as close to normal as possible, high repetition, progression of challenge, part versus whole task practice, and knowledge of results. Treatment was customized to abilities of each subject and consisted of both MyoPro training and MLB therapy without device. Training with device was progressed using a hierarchy of challenge to increase complexity of movement. MLB therapy without device followed the same hierarchy, incorporating training of movements that could not be accomplished with the device and those that were trained with device. Movement quality was monitored and training practice was incrementally progressed as subject demonstrated improved ability to perform a given task/movement component. Subjects performed a custom home exercise program (HEP) on non-clinic days, increasing repetition as tolerated. At conclusion of in-clinic phase, individuals transitioned to a home phase where they continued to use the HEP.

MyoPro + Motor Learning-Based Therapy

Eligibility Criteria

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

You may qualify if:

• over 18 years of age
• minimum 6 months since injury
• elbow, forearm, wrist and hand have full motion with little resistance from muscles when moved by someone else
• some ability to actively move the shoulder
• able to generate consistent and detectable electrical signals from the upper arm and forearm muscles
• able to read and comprehend the English language
• able to follow two-stage command
• cognitive abilities sufficient to perform testing and training protocols
• able to tolerate functional tasks for 60 minutes without excessive fatigue
• medically and psychologically stable
• at home support from a family member or care giver if needed

You may not qualify if:

• elbow, forearm, wrist and hand have less than full motion with high resistance from muscles when moved by someone else
• shoulder instability, pain or dislocation
• unable to safely support the weight of arm with added weight of the device without pain
• less than 12 weeks since botulinum toxin injection in the impaired arm
• new therapies/medications planned during study period
• skin rash or open wound on impaired arm
• inability to detect light touch or pain on impaired arm
• involuntary movements of the impaired arm
• pain or hypersensitivity in the impaired arm
• inability to understand English

Sponsors & Collaborators

• Northwestern University: lead
• Louis Stokes VA Medical Center: collaborator
• Myomo: collaborator

Study Sites (1)

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Pundik S, McCabe J, Skelly M, Salameh A, Naft J, Chen Z, Tatsuoka C, Fatone S. Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits After Stroke and Traumatic Brain Injury. Front Neurol. 2022 Feb 8;13:791144. doi: 10.3389/fneur.2022.791144. eCollection 2022.

  PMID: 35211080 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Stefania Fatone, Principle Investigator
• Organization: Northwestern University

s-fatone@northwestern.edu

3125035717

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 12, 2017
• Study Start: December 1, 2016
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: July 15, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)