N/A
N=67
Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation
Stroke · Hemiparesis · Hemiplegia
Bottom Line
View on ClinicalTrials.gov: NCT01688856 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment — 13.5; 12.6; 9.6 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical Stimulator (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment |
13.5; 12.6; 9.6 | — |
| SECONDARY Change in Reachable Workspace (RW) at 6 Months Post-Treatment |
430; 166; 152 | — |
| SECONDARY Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment |
11.0; 4.4; 10.7 | — |
| SECONDARY Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment |
2.6; 1.5; 1.9 | — |
| SECONDARY Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment |
1.0; 0.8; 0.9 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01688856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.