Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

NCT ID: NCT00369668

Last Updated: 2012-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-06-30

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).

Conditions

Cerebrovascular Accident; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Intensity

Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.

Group Type: EXPERIMENTAL

Bilateral movements and neuromuscular electrical stimulation

Intervention Type: BEHAVIORAL

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.

Low Intensity

Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.

Group Type: ACTIVE_COMPARATOR

Bilateral movements and neuromuscular electrical stimulation

Intervention Type: BEHAVIORAL

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.

Control

Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation

Group Type: ACTIVE_COMPARATOR

Bilateral movements and sham electrical stimulation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

functional electrical stimulation; functional electrical stimulation; functional electrical stimulation - sham

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

• Minimum Eligible Age: 44 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James H. Cauraugh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Motor Behavior Laboratory, University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19164850 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14617717 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12052996 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14568122 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17904594 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20435515 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21448576 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19926154 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34695300 (View on PubMed)

Other Identifiers

00061194

Identifier Type: -

Identifier Source: org_study_id