Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation

This study is currently recruiting participants.
Verified August 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Jayme Knutson, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01688856
First received: September 17, 2012
Last updated: August 19, 2013
Last verified: August 2013

September 17, 2012
August 19, 2013
July 2012
June 2017   (final data collection date for primary outcome measure)
Box and Block Test [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01688856 on ClinicalTrials.gov Archive Site
  • Fugl-Meyer Motor Assessment (FMA) (upper extremity portion) [ Time Frame: 6 times: Prior to treatment and at 6, 12, 20, 28, and 36 weeks. ] [ Designated as safety issue: No ]
  • Arm Motor Abilities Test (AMAT) [ Time Frame: 6 times: Prior to treatment and at 6, 12, 20, 28, and 36 weeks. ] [ Designated as safety issue: No ]
  • Motor Activity Log (MAL) [ Time Frame: 3 times: Prior to treatment and at 12 and 36 weeks. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation
Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia

Impaired arm and hand function is one of the most disabling and most common consequences of stroke. The Investigators have developed Contralaterally Controlled Functional Electrical Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke. The purpose of this study is to maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific aims and hypotheses are as follows:

AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation.

Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper limb impairment and activity limitation measures than those treated with dose-matched Arm+Hand Cyclic NMES.

AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES.

Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in upper limb impairment and activity limitation than those treated with Hand CCFES.

AIM 3: Describe the relationship between treatment effect and time elapsed between stroke onset and start of treatment.

Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better outcomes.

Loss of arm and hand function is a severely disabling condition that occurs in nearly 75% of the estimated 795,000 Americans who have a new or recurrent stroke each year [Roger 2011]. Upper limb impairment is often characterized by inability to extend the elbow and open the hand. The hope of regaining lost motor function after stroke has been fueled in recent years by the development of new rehabilitation therapies and devices that are aimed at promoting the brain's capacity to reorganize after injury in such a way that restores motor control of paretic limbs [Nudo 2001]. The Investigators' long-term objective is to develop stroke rehabilitation treatments for the hemiparetic upper limb that are optimized for effectiveness, applicability, and deployability.

The primary objective of this project is to estimate the effect of Arm+Hand Contralaterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper limb motor impairment and activity limitation in subacute hemiplegia. CCFES is a treatment aimed at improving recovery of volitional motor function in stroke survivors [Knutson 2007; Knutson 2009; Knutson 2010]. Hand CCFES activates finger and thumb extensors with an intensity of electrical stimulation 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. The Hand CCFES system enables stroke patients to use their impaired hand to practice functional tasks in therapy sessions. CCFES incorporates the following features considered to be important to motor recovery and promoting neuroplasticity: synchronization of motor intent with motor execution of paretic hand opening [Rushton 2003; Kimberley 2004], bilateral symmetric movement [Luft 2004], intensive repetitive hand opening exercises [Lang 2009], and the practice of functional tasks [Nudo 2003]. In a pilot case series study of patients with chronic (> 6 months) post-stroke hemiplegia, all 6 participants experienced some reduction of upper limb motor impairment after several weeks of Hand CCFES [Knutson 2007; Knutson 2009]. The results of a Phase I randomized clinical trial (RCT) of Hand CCFES in 21 patients with subacute (≤ 6 months) hemiplegia suggested that Hand CCFES may be superior to cyclic neuromuscular electrical stimulation (NMES) in reducing upper extremity impairment and activity limitation [Knutson 2011].

In this study, added to the Hand CCFES treatment is stimulated elbow extension controlled by the contralateral elbow. This "next generation" CCFES treatment is called Arm+Hand CCFES. Arm+Hand CCFES therapy is intended to strengthen and improve the motor control of the proximal upper limb as well as the hand, to improve simultaneous reaching and hand opening, a functionally critical movement pattern that is often prevented by paresis and post-stroke flexor synergies. The secondary objective of this project is to evaluate the effect of adding elbow extensor stimulation to the Hand CCFES treatment.

A sample of 108 stroke survivors with acute/subacute (≤ 6 months) upper limb hemiplegia will be randomly assigned in equal proportions to receive 12 weeks of either Arm+Hand CCFES (stimulates elbow extension and hand opening), Hand CCFES (stimulates hand opening), or Arm+Hand Cyclic NMES (stimulates elbow extension and hand opening but with pre-set timing and intensity, i.e., not intention-driven), plus lab-based therapist-guided task practice. Upper limb impairment and activity limitation will be assessed at baseline, 6, 12, 20, 28, and 36 weeks.

This is the first randomized controlled trial of Arm+Hand CCFES in subacute upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of a new treatment for reducing post-stroke disability.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiparesis
  • Hemiplegia
Device: Electrical stimulator

The treatment period will be 13 weeks in duration, divided into two 6-week periods of actual treatment separated by 1 week to do mid-treatment assessments. Thus 12 weeks of actual treatment are provided over a 13 week period. Treatment consists of two components:

  1. Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES groups but not for Cyclic NMES group during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, the cyclic NMES group has slightly lengthened stimulated hand opening exercise sessions at home than the CCFES groups.)
  2. Self-administered hand opening exercise performed 10 sessions per week at home using the device.
  • Experimental: Arm+Hand CCFES
    Uses an electrical stimulator that activates the muscles of the paretic arm and hand in response to and with an intensity proportional to movement of the contralateral arm and hand. The finger and thumb extensors will be stimulated, as well as the elbow extensors. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 75 min of functional task practice twice a week in the laboratory for 12 weeks.
    Intervention: Device: Electrical stimulator
  • Experimental: Hand CCFES
    Uses an electrical stimulator that activates the muscles of the paretic hand in response to and with an intensity proportional to movement of the contralateral hand. The finger and thumb extensors will be stimulated. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 75 min of functional task practice twice a week in the laboratory for 12 weeks.
    Intervention: Device: Electrical stimulator
  • Active Comparator: Arm+Hand Cyclic NMES
    Uses an electrical stimulator which delivers stimulation automatically and repeatedly with preprogrammed timing and intensity. The finger and thumb extensors will be stimulated, as well as the elbow extensors. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 75 min of functional task practice twice a week in the laboratory for 12 weeks.
    Intervention: Device: Electrical stimulator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 21 and ≤ 80
  • ≤ 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
  • Skin intact on hemiparetic arm and hand
  • Able to follow 3-stage commands
  • Able to recall 2 of 3 items after 30 minutes
  • Medically stable
  • MRC ≤ 4 for finger extensors on paretic side
  • Adequate movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
  • Caregiver available to assist with device daily - OR - able to independently don elbow cuff on unaffected arm
  • Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
  • Upper extremity hand section of FMA ≥ 1 AND ≤ 11/14
  • Unable to simultaneously fully extend the elbow and fully open the hand toward tabletop object with arm unsupported (i.e. cannot voluntarily achieve the maximum PROM available)
  • Functional PROM (minimal resistance) at shoulder, elbow, wrist, and hand simultaneously on affected side (i.e., there exists enough PROM to reach and acquire table-top objects).
  • Able to hear and respond to stimulator cues
  • While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
  • While relaxed with the forearm supported with a mobile arm support, surface NMES of elbow extensors (triceps) produces functional elbow extension without pain.
  • Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment.

Exclusion Criteria:

  • Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
  • Severely impaired cognition and communication
  • Uncontrolled seizure disorder
  • History of cardiac arrhythmias with hemodynamic instability
  • Cardiac pacemaker or other implanted electronic device
  • Pregnant
  • IM Botox injections in any UE muscle in the last 3 months
  • Insensate arm, forearm, or hand
  • Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
  • Severe shoulder or hand pain
  • Severe depression on Beck Depression Inventory (>=13 on BDI-fast screen)
Both
21 Years to 80 Years
No
Contact: Peggy Maloney, RN 216-957-3558 mmaloney@metrohealth.org
United States
 
NCT01688856
R01HD068588
No
Jayme Knutson, Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Jayme S. Knutson, PhD Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP