NCT03058796

Brief Summary

Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_2

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 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

February 16, 2017

Results QC Date

March 29, 2023

Last Update Submit

March 29, 2023

Conditions

Upper Extremity HemiplegiaStroke

Keywords

strokerehabilitationHemiplegia

Outcome Measures

Primary Outcomes (1)

  • Box and Block Test Score

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

    0 weeks,12 weeks, 36 weeks

Secondary Outcomes (1)

  • Action Research Arm Test (ARAT) Score

    0 weeks, 12 weeks, 36 weeks

Study Arms (2)

CCFES Therapy

ACTIVE COMPARATOR

CCFES uses surface electrodes 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. CCFES enables stroke survivors to open and close their paretic hand and practice using it in therapy sessions. The treatment regimen includes CCFES-mediated: 1) home-based self-administered hand opening exercises, and 2) lab-based therapist-guided functional task practice.

Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)

CCFES Video Game Therapy

EXPERIMENTAL

CCFES Video Game Therapy integrates custom designed hand therapy video games with CCFES which enables participants to use the video game component at home instead of repetitive hand opening exercises.

Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)Device: Hand Therapy Video Games

Interventions

Contralaterally Controlled Functional Electrical Stimulation (CCFES)DEVICE

The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. uses surface electrodes 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.

Also known as: CCFES
CCFES TherapyCCFES Video Game Therapy
Hand Therapy Video GamesDEVICE

The use of video games with CCFES to encourage therapeutic hand movement at home

Also known as: HTVG
CCFES Video Game Therapy

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
  • age 21-80 years old
  • unilateral upper limb hemiparesis with finger extensor strength of grade \<=4/5 on the Medical Research Council (MRC) scale AND a score of \>=1 and \<=11/14 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 2 of 3 words after 30 minutes
  • surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening)
  • Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects
  • intact vision and hearing
  • medically stable
  • full voluntary opening/closing of the contralateral (less affected) hand
  • demonstrate 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
  • severely impaired cognition and communication
  • uncompensated hemineglect
  • arm or forearm skin breakdown or edema (to avoid edema-related shunting of current)
  • insensate forearm (to avoid risk of electrical burns)
  • 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 stimulation during pregnancy
  • participating in occupational therapy or other rehabilitation therapies to the upper extremity
  • severe shoulder or hand pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Knutson JS, Fu MJ, Cunningham DA, Hisel TZ, Friedl AS, Gunzler DD, Plow EB, Busch RM, Pundik S. Contralaterally controlled functional electrical stimulation video game therapy for hand rehabilitation after stroke: a randomized controlled trial. Disabil Rehabil. 2024 Sep;46(19):4466-4475. doi: 10.1080/09638288.2023.2278174. Epub 2023 Nov 14.

    PMID: 37962171DERIVED

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Jayme Knutson
Organization
The MetroHealth System
jsk12@case.edu
216-957-3557

Study Officials

  • Jayme S. Knutson, PhD

    Louis Stokes VA Medical Center, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

June 19, 2017

Primary Completion

June 13, 2022

Study Completion

September 30, 2022

Last Updated

January 5, 2024

Results First Posted

January 5, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)