Clinical trial NCT00369668: Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments
Official title: Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebrovascular Accident
Hemiplegia
Keywords: Rehabilitation
Physical Therapy Techniques
Occupational Therapy
Upper Extremity; Motor skills
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2006-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 44
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.

Detailed description: Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).

Eligibility criteria: Inclusion Criteria:

* an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
* score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
* an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
* unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
* free of major post stroke complications
* able to attend therapy 2 days/week or 4 days/week for 2 weeks
* score at least a 16 on the Mini Mental Status Examination
* able to discriminate sharp from dull and light touch using traditional sensation tests.

Exclusion Criteria:

* hemiparetic arm is insensate
* motor impairments from stroke on opposite side of body
* pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
* Legal blindness or severe visual impairment; 5) Life expectancy less than one year
* Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension \< 40º; passive wrist extension \< 40º; passive elbow extension \<40º; shoulder flexion/abduction \< 80º)
* History of sustained alcoholism or drug abuse in the last six months
* Has pacemaker or other implanted device
* pregnant

Primary outcomes:
measure: Box and Block Test; Data Collected = Number of Blocks Moved
timeFrame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
measure: Fugl-Meyer Upper Extremity Motor Test
timeFrame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
measure: Fractionated Reaction Time
timeFrame: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Motor Behavior Laboratory, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: James H. Cauraugh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cauraugh JH, Coombes SA, Lodha N, Naik SK, Summers JJ. Upper extremity improvements in chronic stroke: coupled bilateral load training. Restor Neurol Neurosci. 2009;27(1):17-25. doi: 10.3233/RNN-2009-0455.
citation: Cauraugh JH, Kim SB. Stroke motor recovery: active neuromuscular stimulation and repetitive practice schedules. J Neurol Neurosurg Psychiatry. 2003 Nov;74(11):1562-6. doi: 10.1136/jnnp.74.11.1562.
citation: Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.
citation: Cauraugh JH, Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci. 2003 Nov 15;215(1-2):13-9. doi: 10.1016/s0022-510x(03)00169-2.
citation: Richards LG, Stewart KC, Woodbury ML, Senesac C, Cauraugh JH. Movement-dependent stroke recovery: a systematic review and meta-analysis of TMS and fMRI evidence. Neuropsychologia. 2008 Jan 15;46(1):3-11. doi: 10.1016/j.neuropsychologia.2007.08.013. Epub 2007 Aug 24.
citation: Lodha N, Naik SK, Coombes SA, Cauraugh JH. Force control and degree of motor impairments in chronic stroke. Clin Neurophysiol. 2010 Nov;121(11):1952-61. doi: 10.1016/j.clinph.2010.04.005.
citation: Naik SK, Patten C, Lodha N, Coombes SA, Cauraugh JH. Force control deficits in chronic stroke: grip formation and release phases. Exp Brain Res. 2011 May;211(1):1-15. doi: 10.1007/s00221-011-2637-8. Epub 2011 Mar 30.
citation: Cauraugh JH, Lodha N, Naik SK, Summers JJ. Bilateral movement training and stroke motor recovery progress: a structured review and meta-analysis. Hum Mov Sci. 2010 Oct;29(5):853-70. doi: 10.1016/j.humov.2009.09.004. Epub 2009 Nov 18.
citation: Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.