Clinical trial NCT02364700: Portable EMG-triggered Hand Robot for Individuals After Stroke
Official title: Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke, robotics, hand rehabilitation
Lead sponsor: Rehab-Robotics Company Limited
Sponsor class: INDUSTRY
Collaborators: name: New York Presbyterian Hospital
First posted: 2015-02-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.

Detailed description: The HOH will be used to provide hand training for patients with decreased hand ability after stroke. The HOH is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. The HOH works by detecting surface EMG muscle activity and therefore requires active participation from the patient throughout the session. Video games linked to the HOH device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of stroke \> 6 months ago
2. Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test.
3. Intact sensation in the affected hand
4. Full passive range of motion (PROM) in mass flexion and extension of the hand
5. MAS score \< 3 for finger flexors and intrinsics
6. MAS score \< 3 for finger extensors
7. Visual tracking is intact in all directions
8. Patient must be otherwise medically stable in the opinion of the principal investigator

Exclusion Criteria:

1. Patient is receiving active occupational or physical therapy for the affected arm
2. Patient has joint contractures that prevent proper fit into the HOH device
3. Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis
4. It has been less than 3 months since last botulinum toxin injection in the affected arm

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity (FMA)
timeFrame: baseline to 6 weeks (discharge)
measure: Arm Motor Ability Test (AMAT)
timeFrame: Baseline to 6 weeks (discharge)
measure: Box and Blocks
timeFrame: Baseline to 6 weeks (discharge)
Secondary outcomes:
measure: Stroke Upper Limb Capacity Scale (SULCS)
timeFrame: Baseline to 6 weeks (discharge)
measure: Hand Dynamometry
timeFrame: baseline to 6 weeks (discharge)
measure: Stroke Impact Scale --Hand Sub Scale (SIS-H)
timeFrame: baseline to 6 weeks (discharge)
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork Presbyterian Hospital-Weill Cornell Medical Center
state: New York
Study officials:
References:
citation: O'Dell MW, Lin CC, Harrison V. Stroke rehabilitation: strategies to enhance motor recovery. Annu Rev Med. 2009;60:55-68. doi: 10.1146/annurev.med.60.042707.104248.
citation: Tong KY, Ho SK, Pang PK, Hu XL, Tam WK, Fung KL, Wei XJ, Chen PN, Chen M. An intention driven hand functions task training robotic system. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3406-9. doi: 10.1109/IEMBS.2010.5627930.
citation: Ho NS, Tong KY, Hu XL, Fung KL, Wei XJ, Rong W, Susanto EA. An EMG-driven exoskeleton hand robotic training device on chronic stroke subjects: task training system for stroke rehabilitation. IEEE Int Conf Rehabil Robot. 2011;2011:5975340. doi: 10.1109/ICORR.2011.5975340.
citation: Hu XL, Tong KY, Wei XJ, Rong W, Susanto EA, Ho SK. The effects of post-stroke upper-limb training with an electromyography (EMG)-driven hand robot. J Electromyogr Kinesiol. 2013 Oct;23(5):1065-74. doi: 10.1016/j.jelekin.2013.07.007. Epub 2013 Aug 7.
citation: Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.