Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke

NCT ID: NCT03215771

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-06-12

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.

Detailed Description

This study had two aims: (1) to evaluate therapeutic and neuroplastic effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy and (2) to evaluate the functional effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy. The investigators planned to recruit 15 Veterans and non-veterans who had Traumatic Brain Injury (TBI) or stroke and upper limb impairment, were over 18 years of age and a minimum of 6 months from injury. 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.

Subjects were enrolled in the study if they met eligibility criteria assessed at a screening visit. Once enrolled subjects were fit with a custom fabricated MyoPro Motion-G elbow-wrist-hand orthosis following standard clinical procedures. This process required up to three visits to cast, trial fit and deliver the orthosis. Subjects then participated in a standard-of-care motor learning based therapy protocol in conjunction with the PERL ("Push Eat Reach Lift") training program recommended by Myomo, which consists of a 9 week, 18 session training plan. Every second week, there was one session that combined therapy/training and outcomes evaluation.

Conditions

Traumatic Brain Injury; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MyoPro + Motor Learning-Based Therapy

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.

Group Type: EXPERIMENTAL

MyoPro Motion-G

Intervention Type: DEVICE

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

Motor Learning-Based Therapy

Intervention Type: 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.

Interventions

MyoPro Motion-G

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

Intervention Type: DEVICE

Motor Learning-Based Therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louis Stokes VA Medical Center

FED

Sponsor Role: collaborator

Myomo

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Stefania Fatone, PhD, BPO(Hons)

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35211080 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W81XWH-16-1-0733

Identifier Type: -

Identifier Source: org_study_id