NCT03574623

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

4 active sites

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

June 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 3, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

June 20, 2018

Results QC Date

January 26, 2026

Last Update Submit

March 2, 2026

Conditions

StrokeUpper Extremity ParesisHemiplegia

Keywords

strokerehabilitationtherapyelectrical stimulationhand

Outcome Measures

Primary Outcomes (1)

  • Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment

    The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.

    Baseline to 6 months post-treatment

Secondary Outcomes (4)

  • Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment

    Baseline to 6 months post-treatment

  • Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment

    Baseline to 6 months post-treatment

  • Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment

    Baseline to 6 months post-treatment

  • Responder Rate

    Baseline to 6 months post-treatment

Study Arms (3)

CCFES

EXPERIMENTAL

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.

Device: Electrical StimulatorBehavioral: Occupational Therapy

cNMES

ACTIVE COMPARATOR

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.

Device: Electrical StimulatorBehavioral: Occupational Therapy

Task Oriented Therapy

ACTIVE COMPARATOR

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.

Behavioral: Occupational Therapy

Interventions

Electrical StimulatorDEVICE

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).

CCFEScNMES
Occupational TherapyBEHAVIORAL

Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

CCFESTask Oriented TherapycNMES

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University and Atlanta VA

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MetroHealth Rehabilitation Institute

Cleveland, Ohio, 44109, United States

Location

Related Publications (2)

  • Knutson JS, Friedl AS, Hansen KM, Harley MY, Hogan SD, Cunningham DA, Hisel TZ, Plow EB, Barrett AM, Raghavan P, Boukrina O, Nahab F, Gunzler DD, Chae J. Contralaterally Controlled Functional Electrical Stimulation for Upper Extremity Recovery Following Stroke: A Multisite Randomized Controlled Trial. Stroke. 2026 Feb;57(2):338-348. doi: 10.1161/STROKEAHA.125.052891. Epub 2025 Nov 13.

    PMID: 41230603DERIVED

  • 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.

    PMID: 35549747DERIVED

MeSH Terms

Conditions

StrokeParesisHemiplegia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParalysis

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Results Point of Contact

Title
Dr. Jayme Knutson
Organization
The MetroHealth System
jknutson@metrohealth.org
216-957-3557

Study Officials

  • Jayme Knutson, PhD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Scientist

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 2, 2018

Study Start

February 15, 2019

Primary Completion

October 16, 2024

Study Completion

October 16, 2024

Last Updated

March 20, 2026

Results First Posted

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)