Therapies for Recovery of Hand Function After Stroke

NCT ID: NCT03574623

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2024-10-16

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.

Conditions

Stroke; Upper Extremity Paresis; Hemiplegia

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Electrical Stimulator

Intervention Type: DEVICE

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).

Occupational Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Electrical Stimulator

Intervention Type: DEVICE

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).

Occupational Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Occupational Therapy

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: DEVICE

Occupational Therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jayme Knutson

Senior Staff Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayme Knutson, PhD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

Emory University and Atlanta VA

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Kessler Foundation

West Orange, New Jersey, United States

MetroHealth Rehabilitation Institute

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35549747 (View on PubMed)

Other Identifiers

R01HD092351

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB17-00884

Identifier Type: -

Identifier Source: org_study_id