Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation

Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01688856

Enrollment

Registered

2012-09-20

Start date

2013-01-31

Completion date

2018-08-31

Last updated

2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis, Hemiplegia, Stroke

Keywords

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

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.

Detailed description

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. Stroke survivors who are ≤ 2 years post-stroke with upper limb hemiplegia will be randomly assigned 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.

Interventions

DEVICEElectrical Stimulator

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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. * 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, 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)

Design outcomes

Primary

Measure	Time frame	Description
Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment	2 timepoints: prior to treatment, 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.

Secondary

Measure	Time frame	Description
Change in Reachable Workspace (RW) at 6 Months Post-Treatment	2 timepoints: prior to treatment, 6 months post-treatment	Reachable Workspace (RW) is the area (cm\^2) traced out when reaching for a target moving in a circular path just outside the reach of the participant.
Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment	2 timepoints: prior to treatment, 6 months post-treatment	The Upper Extremity Fugl-Meyer (UEFM) is an assessment of motor impairment of the upper limb in which the participant is asked to make specific movements of the arm, forearm, wrist, and hand. Each movement is scored 0, 1, or 2 and the subscores are summed. Min=0; Max=66. Higher scores mean a better outcome.
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment	2 timepoints: prior to treatment, 6 months post-treatment	Stroke Upper Limb Capacity Scale (SULCS) is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity. Min=0; Max=10. Higher scores mean a better outcome.
Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment	2 timepoints: prior to treatment, 6 months post-treatment	The Arm Motor Abilities Test (AMAT) is an assessment of the participant's ability to do 9 standardized upper limb tasks. Each task is composed of 1 to 3 component tasks, each of which is rated on an ordinal scale of 0 to 5. The final score is the average of all component task scores across all 9 compound tasks. Min=0; Max=5. Higher scores mean a better outcome.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Arm+Hand CCFES 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. Electrical stimulator: The 12-week treatment period consists of two components: 1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory. 2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.	28
Hand CCFES Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand. Electrical stimulator: The 12-week treatment period consists of two components: 1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory. 2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.	28
Arm+Hand Cyclic NMES Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity. Electrical stimulator: The 12-week treatment period consists of two components: 1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.) 2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.	11
Total	67

Baseline characteristics

Characteristic	Arm+Hand CCFES	Hand CCFES	Arm+Hand Cyclic NMES	Total
Age, Continuous	54 years STANDARD_DEVIATION 12.6	60 years STANDARD_DEVIATION 11.5	61 years STANDARD_DEVIATION 12.5	58 years STANDARD_DEVIATION 12.5
Race/Ethnicity, Customized Black or African American	13 Participants	7 Participants	2 Participants	22 Participants
Race/Ethnicity, Customized Other	2 Participants	2 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized White	13 Participants	19 Participants	9 Participants	41 Participants
Sex: Female, Male Female	9 Participants	7 Participants	8 Participants	24 Participants
Sex: Female, Male Male	19 Participants	21 Participants	3 Participants	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 28	0 / 11
other Total, other adverse events	4 / 28	7 / 28	2 / 11
serious Total, serious adverse events	0 / 28	0 / 28	0 / 11

Outcome results

Primary

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.