Therapies for Recovery of Hand Function After Stroke

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
MetroHealth Medical Center
Study ID
NCT03574623
Status
Completed

Conditions

  • Hemiplegia
  • Stroke
  • Upper Extremity Paresis

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 15, 2019
Status verified
Mar 2026
Primary completion
Oct 16, 2024
Completion
Oct 16, 2024

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment [ Time Frame: Baseline to 6 months post-treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory University and Atlanta VAAtlantaGeorgia30322-
Johns Hopkins UniversityBaltimoreMaryland21205-
Kessler FoundationWest OrangeNew Jersey07052-
MetroHealth Rehabilitation InstituteClevelandOhio44109-

Find similar trials in Atlanta, GA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Emory University and Atlanta VA· Atlanta, GAJohns Hopkins University· Baltimore, MDKessler Foundation· West Orange, NJMetroHealth Rehabilitation Institute· Cleveland, OH

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