Myoelectric Upper Limb Orthosis Use by Persons With Traumatic Brain Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 2016 |
| End Date: | September 2019 |
| Contact: | Svetlana Pundik, MD |
| Email: | svetlana.pundik@va.gov |
| Phone: | 216-791-3800 |
Longitudinal Observation of Myoelectric Upper Limb Orthosis Use Among Veterans With Upper Limb Impairment
The objective of this study is to document longitudinal outcomes in persons with traumatic
brain injury (TBI) using the myoelectric upper limb orthosis with powered elbow and grasp
using both patient centric performance and patient reported outcome measures. Longitudinal
observation will allow the investigators to detect both the initial therapeutic effects as
well as the later functional outcomes of orthosis use. The investigators plan to recruit 15
Veterans and non-veterans who have TBI and upper limb impairment. The study requires 29
visits over 22 weeks and is divided into four parts: enrollment, orthotic fitting,
therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits will
be evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
brain injury (TBI) using the myoelectric upper limb orthosis with powered elbow and grasp
using both patient centric performance and patient reported outcome measures. Longitudinal
observation will allow the investigators to detect both the initial therapeutic effects as
well as the later functional outcomes of orthosis use. The investigators plan to recruit 15
Veterans and non-veterans who have TBI and upper limb impairment. The study requires 29
visits over 22 weeks and is divided into four parts: enrollment, orthotic fitting,
therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits will
be evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
This study has two aims: (1) to evaluate therapeutic and neuroplastic effects of a
myoelectric upper limb orthosis and (2) to evaluate the functional effects of a myoelectric
upper limb orthosis. The investigators plan to recruit 15 Veterans and non-veterans who have
Traumatic Brain Injury (TBI) and upper limb impairment, are over 18 years of age and a
minimum of 6 months from injury. The study requires 29 visits over 22 weeks and is divided
into four parts: enrollment, orthotic fitting, therapy/training (9 weeks), and home use (9
weeks). Therapeutic and functional benefits will be evaluated every 2 to 3 weeks over 18
weeks using simple, short clinical tests.
Subjects will be enrolled in the study if they meet eligibility criteria assessed at a
screening visit. Once enrolled subjects will be custom fit with a MyoPro Motion-G
elbow-wrist-hand orthosis following standard clinical procedures. This process requires up to
three visits to cast, trial fit and deliver the orthosis. Subjects will then participate 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 will be one session that will combine
therapy/training and outcomes evaluation.
Once subjects have completed the therapy/training phase and demonstrated competency with
orthosis use, they will start a 9 week home use program during which time they will be
contacted by the therapist and seen as needed in the clinic to trouble-shoot any technical
issues, monitor for adverse events and/or upgrade their home program. Every third week there
will be one session at the clinic for outcomes evaluation.
myoelectric upper limb orthosis and (2) to evaluate the functional effects of a myoelectric
upper limb orthosis. The investigators plan to recruit 15 Veterans and non-veterans who have
Traumatic Brain Injury (TBI) and upper limb impairment, are over 18 years of age and a
minimum of 6 months from injury. The study requires 29 visits over 22 weeks and is divided
into four parts: enrollment, orthotic fitting, therapy/training (9 weeks), and home use (9
weeks). Therapeutic and functional benefits will be evaluated every 2 to 3 weeks over 18
weeks using simple, short clinical tests.
Subjects will be enrolled in the study if they meet eligibility criteria assessed at a
screening visit. Once enrolled subjects will be custom fit with a MyoPro Motion-G
elbow-wrist-hand orthosis following standard clinical procedures. This process requires up to
three visits to cast, trial fit and deliver the orthosis. Subjects will then participate 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 will be one session that will combine
therapy/training and outcomes evaluation.
Once subjects have completed the therapy/training phase and demonstrated competency with
orthosis use, they will start a 9 week home use program during which time they will be
contacted by the therapist and seen as needed in the clinic to trouble-shoot any technical
issues, monitor for adverse events and/or upgrade their home program. Every third week there
will be one session at the clinic for outcomes evaluation.
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
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