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Completed

NCT Number: NCT03058796

Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke

Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

About this study

A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke

  • age 21-80 years old
  • unilateral upper limb hemiparesis with finger extensor strength of grade <=4/5 on the Medical Research Council (MRC) scale AND a score of >=1 and <=11/14 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 2 of 3 words after 30 minutes
  • surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening)
  • Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects
  • intact vision and hearing
  • medically stable
  • full voluntary opening/closing of the contralateral (less affected) hand
  • demonstrate 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
  • severely impaired cognition and communication
  • uncompensated hemineglect
  • arm or forearm skin breakdown or edema (to avoid edema-related shunting of current)
  • insensate forearm (to avoid risk of electrical burns)
  • 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 stimulation during pregnancy
  • participating in occupational therapy or other rehabilitation therapies to the upper extremity
  • severe shoulder or hand pain

Treatment and study plan

Contralaterally Controlled Functional Electrical Stimulation (CCFES)

Device

The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. uses surface electrodes 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.

Other names: CCFES

Hand Therapy Video Games

Device

The use of video games with CCFES to encourage therapeutic hand movement at home

Other names: HTVG

Primary outcomes

  1. Box and Block Test Score

    Time frame: 0 weeks,12 weeks, 36 weeks

    The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

Secondary outcomes

  1. Action Research Arm Test (ARAT) Score

    Time frame: 0 weeks, 12 weeks, 36 weeks

    The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional)

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2017
Registry last updated
Jan 5, 2024

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.

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