Clinical trial NCT03574623: Therapies for Recovery of Hand Function After Stroke
Official title: Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Hemiplegia
Keywords: stroke
rehabilitation
therapy
electrical stimulation
hand
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Kessler Foundation
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: The Cleveland Clinic
name: Johns Hopkins University
name: Emory University
First posted: 2018-07-02
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.

Eligibility criteria: Inclusion Criteria:

* 6 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

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
* 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

Primary outcomes:
measure: Box and Blocks Test (BBT) change
timeFrame: 0 to 12 weeks, 0 to 36 weeks
Secondary outcomes:
measure: Upper Extremity Fugl Meyer (UEFM) change
timeFrame: 0 to 12 weeks, 0 to 36 weeks
measure: Action Research Arm Test (ARAT) change
timeFrame: 0 to 12 weeks, 0 to 36 weeks
measure: Stroke Upper Limb Capacity Scale (SULCS) change
timeFrame: 0 to 12 weeks, 0 to 36 weeks
measure: Responder Rate
timeFrame: 0 to 36 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University and Atlanta VA
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Cleveland
country: United States
facility: MetroHealth Rehabilitation Institute
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Jayme Knutson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.