Skip to main content
OpenTrials
Completed

NCT Number: NCT03574623

Therapies for Recovery of Hand Function After Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University and Atlanta VA, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulator

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

Behavioral

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

Primary outcomes

  1. Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment

    Time frame: Baseline to 6 months post-treatment

    The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.

Secondary outcomes

  1. Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment

    Time frame: Baseline to 6 months post-treatment

    The UEFM is a measure of upper limb motor impairment with a minimum score of 0 and maximum score of 66. The higher the score, the better the motor recovery.

  2. Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment

    Time frame: Baseline to 6 months post-treatment

    The ARAT is a measure of arm and hand function with a minimum score of 0 and maximum score of 57. The higher the score, the better the motor recovery.

  3. Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment

    Time frame: Baseline to 6 months post-treatment

    The SULCS is a measure of upper limb capacity with a minimum score of 0 and maximum score of 10. The higher the score, the better the motor recovery.

  4. Responder Rate

    Time frame: Baseline to 6 months post-treatment

    Proportion of participants who had a gain of at least 6 points on the UEFM

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • 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

Registry information

Official study title

Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2018
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.