Clinical trial NCT03263286: Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton
Official title: Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: The Catholic University of America
Sponsor class: OTHER
Collaborators: name: MedStar National Rehabilitation Network
First posted: 2017-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke victims regain functional use of their hand and regain independent living. Participants will use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes from the intervention after the 8 weeks and also at a 3 month followup.

Detailed description: After stroke, individuals often have great difficulty with using the affected hand in functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger extensor weakness. This leads to increased difficulty in grasp and release of objects. HandSOME is a light weight wearable hand orthosis that increases range of motion and decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME device's effectiveness in the rehabilitation of stroke patients through an 8 week intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit per week to the clinic to evaluate progress and troubleshoot problems with the device. The hypotheses are that the gains from the 8 weeks of training will be statistically significant and clinically important (defined as gains of greater than 10% of full scale) in the domains of impairment, function and amount of arm use.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of stroke more than six months prior to entry into the study
2. Impaired ability to open affected the hand
3. At least trace ability to extend the wrist and fingers

Exclusion Criteria:

1. Have cognitive deficits that could negatively affect their ability to complete the protocols as evidenced by a score of 24 or less on the Folstein Mini-Mental State Examination
2. Have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
3. Have serious uncontrolled medical problems as judged by the project therapist
4. Receiving oral or injected antispasticity medications during study treatment
5. MCP and IP passive extension limit \> 30 degrees from full extension
6. Excessive tone in the fingers and thumb as determined by Ashworth scores \>=3

Primary outcomes:
measure: Change in Fugl-Meyer Test of Arm Function
timeFrame: Change from baseline Fugl-Meyer score at 2 months
measure: Change in Action Research Arm Test
timeFrame: Change from baseline Action Research Arm Test score at 2 months
measure: Change in Motor Activity Log
timeFrame: Change from baseline Motor Activity Log score at 2 months
Secondary outcomes:
measure: Change in Fugl-Meyer Test of Arm Function at followup
timeFrame: Change from baseline Fugl-Meyer score at 5 months
measure: Change in Action Research Arm Test at followup
timeFrame: Change from baseline Action Research Arm Test score at 5 months
measure: Change in Motor Activity Log at followup
timeFrame: Change from baseline Motor Activity Log score at 5 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Network
state: District of Columbia
Study officials:
References:
citation: Tianyao Chen, Lum PS. Hand rehabilitation after stroke using a wearable, high DOF, spring powered exoskeleton. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:578-581. doi: 10.1109/EMBC.2016.7590768.