Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

Cerebrovascular Accident Clinical Trial

Official title:

Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369668
• Other study ID #: 00061194
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2006
• Last updated: June 12, 2012
• Start date: August 2006
• Est. completion date: June 2009

Study information

• Verified date: April 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 44 Years to 86 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiplegia
• Stroke

Intervention

Behavioral:
• Bilateral movements and neuromuscular electrical stimulation
Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.
• Bilateral movements and neuromuscular electrical stimulation
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
• Bilateral movements and sham electrical stimulation
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.

Locations

Country	Name	City	State
United States	Motor Behavior Laboratory, University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Erratum in: Clin Neurophysiol. 2011 Feb;122(2):423. — View 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. — View 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. Epub 2007 Aug 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Block Test; Data Collected = Number of Blocks Moved	A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.	Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)	No
Primary	Fugl-Meyer Upper Extremity Motor Test	FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.	Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)	No
Primary	Fractionated Reaction Time	Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.	Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)	No