Therapies for Recovery of Hand Function After Stroke

Stroke Clinical Trial

Official title:

Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03574623
• Other study ID #: IRB17-00884
• Secondary ID: R01HD092351
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University and Atlanta VA	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	MetroHealth Rehabilitation Institute	Cleveland	Ohio
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Blocks Test (BBT) change	The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.	0 to 12 weeks, 0 to 36 weeks
Secondary	Stroke Upper Limb Capacity Scale (SULCS) change	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.	0 to 12 weeks, 0 to 36 weeks