NCT03574623

Therapies for Recovery of Hand Function After Stroke

Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-15
• Primary completion: 2024-10-16
• Completion: 2024-10-16
• First posted: 2018-07-02
• Last updated: 2026-03-20
• Results posted: 2026-03-03

Locations

4 sites across 1 country: United States