Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation

NCT01688856 | Completed Results

• 2 other identifiers: IRB12-00493R01HD068588
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Hemiparesis; Hemiplegia

Keywords

hand; arm; stroke; hemiplegia; electrical stimulation; recovery; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment

  The BBT counts how many blocks a participant can pick up, move over a barrier, and release in 60 seconds. Higher scores mean a better outcome.

  2 timepoints: prior to treatment, 6 months post-treatment

Secondary Outcomes (4)

• Change in Reachable Workspace (RW) at 6 Months Post-Treatment

  2 timepoints: prior to treatment, 6 months post-treatment

• Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment

  2 timepoints: prior to treatment, 6 months post-treatment

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

  2 timepoints: prior to treatment, 6 months post-treatment

• Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment

  2 timepoints: prior to treatment, 6 months post-treatment

Study Arms (3)

Arm+Hand CCFES

EXPERIMENTAL

Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks.

Device: Electrical Stimulator

Hand CCFES

EXPERIMENTAL

Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks.

Device: Electrical Stimulator

Arm+Hand Cyclic NMES

ACTIVE COMPARATOR

Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks.

Device: Electrical Stimulator

Interventions

Electrical Stimulator DEVICE

The 12-week treatment period consists of two components: 1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. If Arm+Hand CCFES or Hand CCFES, the stimulator is used during task practice. 2. Self-administered muscle stimulation exercise performed 10 sessions per week at home using the device. If Arm+Hand CCFES or Hand CCFES, each session is 46 minutes. If Arm+Hand Cyclic NMES, each session is 60 minutes.

Arm+Hand CCFES; Arm+Hand Cyclic NMES; Hand CCFES

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 and ≤ 80
• ≤ 2 years 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
• Finger extensor paresis indicated by a score of ≤ 4 out of 5 on the manual muscle test (Medical Research Council scale)
• 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 Upper Extremity Fugl-Meyer (UEFM)≥ 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 passive range of motion (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.

You may not qualify if:

• Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's Disease, Spinal Cord Injury, Traumatic Brain Injury, Multiple Sclerosis).
• 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 (BDI) (score\>=13 on BDI-fast screen)

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Case Western Reserve University: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (12)

• Nudo RJ, Plautz EJ, Frost SB. Role of adaptive plasticity in recovery of function after damage to motor cortex. Muscle Nerve. 2001 Aug;24(8):1000-19. doi: 10.1002/mus.1104.

  PMID: 11439375 BACKGROUND

• Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.

  PMID: 17398254 BACKGROUND

• Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.

  PMID: 18812432 BACKGROUND

• Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.

  PMID: 20531158 BACKGROUND

• Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey LL, Lojovich JM, Carey JR. Electrical stimulation driving functional improvements and cortical changes in subjects with stroke. Exp Brain Res. 2004 Feb;154(4):450-60. doi: 10.1007/s00221-003-1695-y. Epub 2003 Nov 15.

  PMID: 14618287 BACKGROUND

• Rushton DN. Functional electrical stimulation and rehabilitation--an hypothesis. Med Eng Phys. 2003 Jan;25(1):75-8. doi: 10.1016/s1350-4533(02)00040-1.

  PMID: 12485788 BACKGROUND

• Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.

  PMID: 15494583 BACKGROUND

• Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005.

  PMID: 19801058 BACKGROUND

• Nudo RJ. Adaptive plasticity in motor cortex: implications for rehabilitation after brain injury. J Rehabil Med. 2003 May;(41 Suppl):7-10. doi: 10.1080/16501960310010070.

  PMID: 12817650 BACKGROUND

• Knutson JS, Harley MY, Hisel TZ, Hogan SD, Maloney MM, Chae J. Contralaterally controlled functional electrical stimulation for upper extremity hemiplegia: an early-phase randomized clinical trial in subacute stroke patients. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):239-46. doi: 10.1177/1545968311419301. Epub 2011 Aug 29.

  PMID: 21875892 BACKGROUND

• Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.

  PMID: 21160056 BACKGROUND

• Knutson JS, Friedl AS, Hansen KM, Hisel TZ, Harley MY. Convergent Validity and Responsiveness of the SULCS. Arch Phys Med Rehabil. 2019 Jan;100(1):140-143.e1. doi: 10.1016/j.apmr.2018.07.433. Epub 2018 Aug 24.

  PMID: 30148996 DERIVED

Related Links

• Cleveland FES Center

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Results Point of Contact

• Title: Dr. Jayme Knutson
• Organization: The MetroHealth System

jsk12@case.edu

216-957-3557

Study Officials

• Jayme S. Knutson, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 31, 2018
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2020-01

Locations

US (1)