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Therapies for Recovery of Hand Function After Stroke

Primary Purpose

Stroke, Upper Extremity Paresis, Hemiplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Stimulator
Occupational Therapy
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, therapy, electrical stimulation, hand

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
  • unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale
  • score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment
  • adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)
  • able to follow 3-stage commands
  • able to recall at least 2 of a list of 3 items after 30 minutes
  • skin intact on the hemiparetic arm
  • surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity)
  • able to hear and respond to cues from stimulator
  • not receiving occupational therapy (no concomitant OT)
  • full voluntary opening/closing of the contralateral (less affected) hand
  • demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them

Exclusion Criteria:

  • co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
  • uncontrolled seizure disorder
  • brainstem stroke
  • uncompensated hemineglect
  • severe shoulder or hand pain
  • insensate forearm or hand
  • history of potentially fatal cardiac arrhythmias with hemodynamic instability
  • implanted electronic systems (e.g. pacemaker)
  • botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
  • pregnant women due to unknown risks of surface NMES during pregnancy
  • lack of functional passive range of motion of the wrist or fingers of affected side
  • diagnosis (apart from stroke) that substantially affects paretic arm and hand function
  • deficits in communication that interfere with reasonable study participation
  • lacking sufficient visual acuity to see the stimulator's display
  • concurrent enrollment in another investigational study

Sites / Locations

  • Emory University and Atlanta VARecruiting
  • Johns Hopkins UniversityRecruiting
  • Kessler FoundationRecruiting
  • MetroHealth Rehabilitation InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CCFES

cNMES

Task Oriented Therapy

Arm Description

Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.

Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.

Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.

Outcomes

Primary Outcome Measures

Box and Blocks Test (BBT) change
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

Secondary Outcome Measures

Stroke Upper Limb Capacity Scale (SULCS) change
The SULCS is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity.

Full Information

First Posted
June 20, 2018
Last Updated
August 21, 2023
Sponsor
MetroHealth Medical Center
Collaborators
Kessler Foundation, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Cleveland Clinic, Johns Hopkins University, Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03574623
Brief Title
Therapies for Recovery of Hand Function After Stroke
Official Title
Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
Kessler Foundation, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Cleveland Clinic, Johns Hopkins University, Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.
Detailed Description
A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis, Hemiplegia
Keywords
stroke, rehabilitation, therapy, electrical stimulation, hand

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCFES
Arm Type
Experimental
Arm Description
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Arm Title
cNMES
Arm Type
Active Comparator
Arm Description
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Arm Title
Task Oriented Therapy
Arm Type
Active Comparator
Arm Description
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Intervention Type
Device
Intervention Name(s)
Electrical Stimulator
Intervention Description
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Intervention Description
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
Primary Outcome Measure Information:
Title
Box and Blocks Test (BBT) change
Description
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
Time Frame
0 to 12 weeks, 0 to 36 weeks
Secondary Outcome Measure Information:
Title
Stroke Upper Limb Capacity Scale (SULCS) change
Description
The SULCS is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity.
Time Frame
0 to 12 weeks, 0 to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions) able to follow 3-stage commands able to recall at least 2 of a list of 3 items after 30 minutes skin intact on the hemiparetic arm surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity) able to hear and respond to cues from stimulator not receiving occupational therapy (no concomitant OT) full voluntary opening/closing of the contralateral (less affected) hand demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them Exclusion Criteria: co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis uncontrolled seizure disorder brainstem stroke uncompensated hemineglect severe shoulder or hand pain insensate forearm or hand history of potentially fatal cardiac arrhythmias with hemodynamic instability implanted electronic systems (e.g. pacemaker) botulinum toxin injections to any upper extremity muscle within 3 months of enrolling pregnant women due to unknown risks of surface NMES during pregnancy lack of functional passive range of motion of the wrist or fingers of affected side diagnosis (apart from stroke) that substantially affects paretic arm and hand function deficits in communication that interfere with reasonable study participation lacking sufficient visual acuity to see the stimulator's display concurrent enrollment in another investigational study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Friedl, OT
Phone
216-778-5347
Email
afriedl@metrohealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayme Knutson, PhD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University and Atlanta VA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Murphy
Phone
404-712-1928
Email
smurph7@emory.edu
First Name & Middle Initial & Last Name & Degree
AM Barrett, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Pena Prieto
Phone
410-955-1347
Email
mpenapr1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Preeti Raghavan, MD
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Masmela
Phone
973-324-3564
Email
jmasmela@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Amanda Khoudary
Phone
973-324-3519
First Name & Middle Initial & Last Name & Degree
Olga Boukrina, PhD
Facility Name
MetroHealth Rehabilitation Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Friedl, OTR/L
Phone
216-957-3581
Email
afriedl@metrohealth.org
First Name & Middle Initial & Last Name & Degree
Jayme Knutson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35549747
Citation
Knutson JS, Friedl AS, Hansen KM, Harley MY, Barrett AM, Raghavan P, Plow EB, Gunzler DD, Chae J. Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial. Trials. 2022 May 12;23(1):397. doi: 10.1186/s13063-022-06303-y.
Results Reference
derived

Learn more about this trial

Therapies for Recovery of Hand Function After Stroke

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