NCT02072369

Brief Summary

The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable stroke

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

Study Start

First participant enrolled

May 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

February 20, 2014

Last Update Submit

June 26, 2017

Conditions

Stroke

Keywords

strokehandfingersrehabilitationtraining

Outcome Measures

Primary Outcomes (8)

  • The Action Research Arm Test (ARAT)

    Change from Baseline after 6 weeks of training

  • Wolf Motor Function Test (WMFT)

    Change from Baseline after 6 weeks of training

  • Fugl-Meyer Upper Extremity Motor Assessment (FMUE)

    Change from Baseline after 6 weeks of training

  • Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)

    Change from Baseline after 6 weeks of training

  • Action Research Arm Test (ARAT)

    Change from Baseline to 1 month following training completion

  • Wolf Motor Function Test (WMFT)

    Change from Baseline to 1 month following training completion

  • Fugl-Meyer Upper Extremity Motor Assessment (FMUE)

    Change from Baseline to 1 month following training completion

  • Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)

    Change from Baseline to 1 month following training completion

Secondary Outcomes (4)

  • Hand Kinematics

    Change from Baseline after 6 weeks of training and 1 month follow up

  • 3-point (palmar) Pinch Strength (PPS)

    Change from Baseline after 6 weeks of training and 1 month follow up

  • Lateral Pinch Strength (LPS)

    Change from Baseline after 6 weeks of training and 1 month follow up

  • Grip Strength (GS)

    Change from Baseline after 6 weeks of training and 1 month follow up

Study Arms (2)

VAEDA Glove

EXPERIMENTAL

Voice And EMG-Driven Actuated glove used during hand occupational therapy training

Other: VAEDA GloveOther: Occupational Therapy

No-glove

ACTIVE COMPARATOR

hand occupational therapy sessions without assistive device

Other: Occupational Therapy

Interventions

VAEDA GloveOTHER

Voice And EMG-Driven Actuated glove used during training

VAEDA Glove
Occupational TherapyOTHER

novel upper extremity occupational therapy focused on the hand

No-gloveVAEDA Glove

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke)
  • moderate hand impairment classified as Stage 4 on the Chedoke McMaster Stroke Assessment

You may not qualify if:

  • anti-spasticity medications/injections taken less than 6 month prior to enrollment
  • contractures greater than 20 degrees
  • inability to follow single-step commands
  • significant upper extremity pain (self-reported pain of greater than 6 on a 10-point scale)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382.

    PMID: 22275586BACKGROUND

  • Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.

    PMID: 19964456BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Derek G Kamper, PhD

    Illinois Institute of Technology / Rehabilitation Institute of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, SMPP, RIC

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 26, 2014

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

December 1, 2014

Last Updated

June 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)