Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke

NCT ID: NCT03058796

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-19
• Study Completion Date: 2022-09-30

Brief Summary

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

Detailed Description

A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.

Conditions

Upper Extremity Hemiplegia; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CCFES Therapy

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.

Group Type: ACTIVE_COMPARATOR

Contralaterally Controlled Functional Electrical Stimulation (CCFES)

Intervention Type: 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.

CCFES Video Game Therapy

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.

Group Type: EXPERIMENTAL

Contralaterally Controlled Functional Electrical Stimulation (CCFES)

Intervention Type: 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.

Hand Therapy Video Games

Intervention Type: DEVICE

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

Interventions

Contralaterally Controlled Functional Electrical Stimulation (CCFES)

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.

Intervention Type: DEVICE

Hand Therapy Video Games

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

Intervention Type: DEVICE

Other Intervention Names

CCFES; HTVG

Eligibility Criteria

Inclusion Criteria

-> 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

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
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayme S. Knutson, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37962171 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I01RX00249

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N2249-R

Identifier Type: -

Identifier Source: org_study_id