NCT00369668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 11, 2012

Completed
Last Updated

June 15, 2012

Status Verified

April 1, 2012

Enrollment Period

2.8 years

First QC Date

August 24, 2006

Results QC Date

August 10, 2011

Last Update Submit

June 12, 2012

Conditions

Cerebrovascular AccidentHemiplegia

Keywords

RehabilitationPhysical Therapy TechniquesOccupational TherapyUpper Extremity; Motor skills

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (3)

High Intensity

EXPERIMENTAL

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

Behavioral: Bilateral movements and neuromuscular electrical stimulation

Low Intensity

ACTIVE COMPARATOR

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

Behavioral: Bilateral movements and neuromuscular electrical stimulation

Control

ACTIVE COMPARATOR

Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation

Behavioral: Bilateral movements and sham electrical stimulation

Interventions

Bilateral movements and neuromuscular electrical stimulationBEHAVIORAL

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.

Also known as: functional electrical stimulation
High Intensity
Bilateral movements and sham electrical stimulationBEHAVIORAL

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.

Also known as: functional electrical stimulation - sham
Control

Eligibility Criteria

Age44 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motor Behavior Laboratory, University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (9)

  • 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.

    PMID: 19164850BACKGROUND

  • 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.

    PMID: 14617717RESULT

  • 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.

    PMID: 12052996RESULT

  • 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.

    PMID: 14568122RESULT

  • 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.

    PMID: 17904594RESULT

  • 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.

    PMID: 20435515RESULT

  • 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.

    PMID: 21448576RESULT

  • 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.

    PMID: 19926154RESULT

  • 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.

    PMID: 34695300DERIVED

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
James Cauraugh, Ph.D., PI
Organization
University of Florida, Motor Behavior Laboratory
jcaura@hhp.ufl.edu
352-294-1623

Study Officials

  • James H. Cauraugh, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 29, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 15, 2012

Results First Posted

May 11, 2012

Record last verified: 2012-04

Locations

US(1)