NCT02364700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

February 5, 2015

Results QC Date

February 7, 2017

Last Update Submit

June 13, 2017

Conditions

Stroke

Keywords

stroke, robotics, hand rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment of Upper Extremity (FMA)

    The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.

    baseline to 6 weeks (discharge)

  • Arm Motor Ability Test (AMAT)

    The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.

    Baseline to 6 weeks (discharge)

  • Box and Blocks

    The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.

    Baseline to 6 weeks (discharge)

Secondary Outcomes (3)

  • Stroke Upper Limb Capacity Scale (SULCS)

    Baseline to 6 weeks (discharge)

  • Hand Dynamometry

    baseline to 6 weeks (discharge)

  • Stroke Impact Scale --Hand Sub Scale (SIS-H)

    baseline to 6 weeks (discharge)

Study Arms (1)

interventional group

EXPERIMENTAL

This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.

Device: Hand of Hope (HOH)

Interventions

Hand of Hope (HOH)DEVICE

Subjects will receive arm training 3x/week for 6 weeks, each session is anticipated to last approximately 60 minutes. Sessions will be scheduled for Monday, Wednesday, and Friday whenever possible to provide a rest period between sessions. Each session will consist of the following: * warm up-passive stretch of hand in flexion and extension (5 minutes); * setting the EMG threshold parameters for the device; * active practicing of opening the hand (Desperate Bee, Hungry Bird, Sun Archer games; 10 min) * active practice of closing then hand (UFO Catcher game; 10 min) * open and closing the hand (Ball and Basket game; 10 min) * open and closing the hand while incorporating reach ( for subjects with adequate ability to reach with shoulder/elbow; 10 min) * cool down-passive stretch of hand in flexion and extension (5 minutes)

interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of stroke \> 6 months ago
  • 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.
  • Intact sensation in the affected hand
  • Full passive range of motion (PROM) in mass flexion and extension of the hand
  • MAS score \< 3 for finger flexors and intrinsics
  • MAS score \< 3 for finger extensors
  • Visual tracking is intact in all directions
  • Patient must be otherwise medically stable in the opinion of the principal investigator

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (5)

  • 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.

    PMID: 18928333BACKGROUND

  • 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.

    PMID: 21097247BACKGROUND

  • 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.

    PMID: 22275545RESULT

  • 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.

    PMID: 23932795RESULT

  • 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.

    PMID: 12907818RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Grace Kim PhD, OTR/L
Organization
New York University
gjk207@nyu.edu
121-998-5846

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 18, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 12, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-06

Locations

US(1)