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Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

Primary Purpose

Cerebrovascular Accident, Hemiplegia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bilateral movements and neuromuscular electrical stimulation
Bilateral movements and neuromuscular electrical stimulation
Bilateral movements and sham electrical stimulation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Rehabilitation, Physical Therapy Techniques, Occupational Therapy, Upper Extremity; Motor skills

Eligibility Criteria

44 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Motor Behavior Laboratory, University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

High Intensity

Low Intensity

Control

Arm Description

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

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

Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2006
Last Updated
June 12, 2012
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00369668
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Hemiplegia
Keywords
Rehabilitation, Physical Therapy Techniques, Occupational Therapy, Upper Extremity; Motor skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity
Arm Type
Experimental
Arm Description
Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
Arm Title
Low Intensity
Arm Type
Active Comparator
Arm Description
Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
Intervention Type
Behavioral
Intervention Name(s)
Bilateral movements and neuromuscular electrical stimulation
Other Intervention Name(s)
functional electrical stimulation
Intervention Description
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
Intervention Name(s)
Bilateral movements and neuromuscular electrical stimulation
Other Intervention Name(s)
functional electrical stimulation
Intervention Description
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
Intervention Name(s)
Bilateral movements and sham electrical stimulation
Other Intervention Name(s)
functional electrical stimulation - sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Box and Block Test; Data Collected = Number of Blocks Moved
Description
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.
Time Frame
Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
Title
Fugl-Meyer Upper Extremity Motor Test
Description
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.
Time Frame
Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
Title
Fractionated Reaction Time
Description
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.
Time Frame
Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H. Cauraugh, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motor Behavior Laboratory, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19164850
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.
Results Reference
background
PubMed Identifier
14617717
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.
Results Reference
result
PubMed Identifier
12052996
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.
Results Reference
result
PubMed Identifier
14568122
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.
Results Reference
result
PubMed Identifier
17904594
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.
Results Reference
result
PubMed Identifier
20435515
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.
Results Reference
result
PubMed Identifier
21448576
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.
Results Reference
result
PubMed Identifier
19926154
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.
Results Reference
result
PubMed Identifier
34695300
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.
Results Reference
derived

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Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

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