Therapies for Recovery of Hand Function After Stroke

Sponsor

MetroHealth Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03574623

Collaborator

Kessler Foundation (Other), National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), The Cleveland Clinic (Other), Johns Hopkins University (Other), Emory University (Other)

129

Enrollment

Locations

Arms

65.5

Anticipated Duration (Months)

32.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Upper Extremity Paresis Hemiplegia	Device: Electrical Stimulator Behavioral: Occupational Therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke

Actual Study Start Date :

Feb 15, 2019

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CCFES Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed 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. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.	Device: Electrical Stimulator An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Behavioral: Occupational Therapy Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
Active Comparator: cNMES Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.	Device: Electrical Stimulator An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Behavioral: Occupational Therapy Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
Active Comparator: Task Oriented Therapy Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.	Behavioral: Occupational Therapy Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Arm

Intervention/Treatment

Experimental: CCFES

Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed 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. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.

Device: Electrical Stimulator

An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).

Behavioral: Occupational Therapy

Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Active Comparator: cNMES

Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.

Device: Electrical Stimulator

Behavioral: Occupational Therapy

Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Active Comparator: Task Oriented Therapy

Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.

Behavioral: Occupational Therapy

Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Outcome Measures

Primary Outcome Measures

Box and Blocks Test (BBT) change [0 to 12 weeks, 0 to 36 weeks]
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

Secondary Outcome Measures

Stroke Upper Limb Capacity Scale (SULCS) change [0 to 12 weeks, 0 to 36 weeks]
The SULCS is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University and Atlanta VA	Atlanta	Georgia	United States	30322
2	Johns Hopkins University	Baltimore	Maryland	United States	21205
3	Kessler Foundation	West Orange	New Jersey	United States	07052
4	MetroHealth Rehabilitation Institute	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

MetroHealth Medical Center
Kessler Foundation
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Cleveland Clinic
Johns Hopkins University
Emory University