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

Stroke Clinical Trial

Official title:

Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058796
• Other study ID #: N2249-R
• Secondary ID: I01RX00249
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 30, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke
• Upper Extremity Hemiplegia

Intervention

Device:
• 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.
• Hand Therapy Video Games
The use of video games with CCFES to encourage therapeutic hand movement at home

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	0 weeks, 12 weeks, 36 weeks