Upper Extremity HemiplegiaPhase 2NCT03058796
Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
A Phase 2 study testing Hand Therapy Video Games in people with Upper Extremity Hemiplegia and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Upper Extremity Hemiplegia, Stroke
- What is being tested?
- Hand Therapy Video Games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -> 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
Official title: Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients
Read the 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
- Being tested
- Contralaterally Controlled Functional Electrical Stimulation (CCFES), Hand Therapy Video Games
- Keywords
- stroke, rehabilitation, Hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contralaterally Controlled Functional Electrical Stimulation (CCFES)Device
Also called 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.
Hand Therapy Video GamesDevice
Also called HTVG
The use of video games with CCFES to encourage therapeutic hand movement at home
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES); Device: Hand Therapy Video Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 weeks,12 weeks, 36 weeks
Secondary outcomes (1)
Action Research Arm Test (ARAT) Score
The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional)
Measured: 0 weeks, 12 weeks, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start19 Jun 2017
- Primary completion13 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity HemiplegiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jayme S. Knutson, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058796
- Sponsor's protocol ID
- N2249-R
- Other IDs
- I01RX00249
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2017
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37962171
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
- ClinicalTrials.gov ID
- NCT03058796
- Acronym / sponsor ID
- N2249-R
- Conditions
- Upper Extremity Hemiplegia, Stroke
- Keywords
- stroke, rehabilitation, Hemiplegia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCFES Therapy | Active comparator | Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)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. |
| CCFES Video Game Therapy | Experimental | Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES), Device: Hand Therapy Video GamesCCFES 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -> 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contralaterally Controlled Functional Electrical Stimulation (CCFES)Also: CCFESThe 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. | Device | CCFES Therapy, CCFES Video Game Therapy |
| Hand Therapy Video GamesAlso: HTVGThe use of video games with CCFES to encourage therapeutic hand movement at home | Device | CCFES Video Game Therapy |
Primary outcome
Box and Block Test Score
Time frame: 0 weeks,12 weeks, 36 weeks
The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
1 secondary outcome
Action Research Arm Test (ARAT) Score
Time frame: 0 weeks, 12 weeks, 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37962171Knutson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayme S. Knutson, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hand Therapy Video Games in people with Upper Extremity Hemiplegia and Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block Test Score (time frame: 0 weeks,12 weeks, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.