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Treatments for Recovery of Hand Function in Acute Stroke Survivors

Primary Purpose

Stroke, Acute, Stroke, Hemiparesis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulator
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring hand, stroke, hemiplegia, electrical stimulation, recovery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 80
  • Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
  • Cortical or subcortical stroke
  • Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on Medical Research Council (MRC) scale)
  • Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
  • Surface NMES of finger and thumb extensors produces functional hand opening without pain
  • Full volitional opening of the contralateral hand of the unimpaired side.
  • Able to follow 3 stage commands
  • Able to remember at least 2 of 3 items after 30 minutes
  • Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
  • Caregiver available and willing to help assist with the device and home regimen and ensure compliance
  • Skin intact on hemiparetic arm
  • Medically stable

Exclusion Criteria:

  • Insensate forearm and/or hand
  • Edema of the affected forearm and/or hand
  • History of potentially fatal cardiac arrhythmias.
  • Cardiac pacemakers or any other implanted electronic systems
  • Pregnant women
  • Uncontrolled seizure disorder
  • Severely impaired cognition or comprehension
  • Uncompensated hemineglect
  • Severe depression (>= 13 on Beck Depression Inventory Fast Screen)
  • Ipsilateral lower motor neuron lesion
  • Parkinson's Disease
  • Spinal cord injury
  • Traumatic brain injury
  • Multiple sclerosis
  • Lack of functional passive range of motion of the wrist or fingers of affected side
  • Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
  • Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CCFES

cNMES

Arm Description

CCFES - Contralaterally Controlled Functional Electrical Stimulation Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity Therapy sessions are done with the subject being assisted by the CCFES system.

cNMES - Cyclic NeuroMuscular Electrical Stimulation. Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation Therapy sessions are done without the stimulation system

Outcomes

Primary Outcome Measures

Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.

Secondary Outcome Measures

Finger Tracking Error
A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.
Box and Blocks Score
The number of blocks picked up and moved across a barrier in 60 seconds
Arm Motor Abilities Test
The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.
Fugl-Meyer Assessment (Upper Extremity)
The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).

Full Information

First Posted
November 27, 2007
Last Updated
November 27, 2018
Sponsor
MetroHealth Medical Center
Collaborators
Case Western Reserve University, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00565045
Brief Title
Treatments for Recovery of Hand Function in Acute Stroke Survivors
Official Title
Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
Case Western Reserve University, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.
Detailed Description
Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand. Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Stroke, Hemiparesis, Hemiplegia
Keywords
hand, stroke, hemiplegia, electrical stimulation, recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCFES
Arm Type
Experimental
Arm Description
CCFES - Contralaterally Controlled Functional Electrical Stimulation Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity Therapy sessions are done with the subject being assisted by the CCFES system.
Arm Title
cNMES
Arm Type
Active Comparator
Arm Description
cNMES - Cyclic NeuroMuscular Electrical Stimulation. Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation Therapy sessions are done without the stimulation system
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulator
Intervention Description
Intervention Characteristics Common to Both Groups • 6-week intervention Home "exercise", daily Exercise (at home) 2 sessions/day A "session" consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions Lab "therapy", 2x/week Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).
Primary Outcome Measure Information:
Title
Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
Description
A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.
Time Frame
3 months post-treatment.
Secondary Outcome Measure Information:
Title
Finger Tracking Error
Description
A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.
Time Frame
3 months post-treatment.
Title
Box and Blocks Score
Description
The number of blocks picked up and moved across a barrier in 60 seconds
Time Frame
3 months post-treatment.
Title
Arm Motor Abilities Test
Description
The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.
Time Frame
3 months post-treatment.
Title
Fugl-Meyer Assessment (Upper Extremity)
Description
The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).
Time Frame
3 months post-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke Cortical or subcortical stroke Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on Medical Research Council (MRC) scale) Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace. Surface NMES of finger and thumb extensors produces functional hand opening without pain Full volitional opening of the contralateral hand of the unimpaired side. Able to follow 3 stage commands Able to remember at least 2 of 3 items after 30 minutes Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator? Caregiver available and willing to help assist with the device and home regimen and ensure compliance Skin intact on hemiparetic arm Medically stable Exclusion Criteria: Insensate forearm and/or hand Edema of the affected forearm and/or hand History of potentially fatal cardiac arrhythmias. Cardiac pacemakers or any other implanted electronic systems Pregnant women Uncontrolled seizure disorder Severely impaired cognition or comprehension Uncompensated hemineglect Severe depression (>= 13 on Beck Depression Inventory Fast Screen) Ipsilateral lower motor neuron lesion Parkinson's Disease Spinal cord injury Traumatic brain injury Multiple sclerosis Lack of functional passive range of motion of the wrist or fingers of affected side Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain) Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayme S Knutson, PhD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17398254
Citation
Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
Results Reference
background
PubMed Identifier
8831470
Citation
Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
Results Reference
background
PubMed Identifier
9596245
Citation
Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.
Results Reference
background
PubMed Identifier
15494583
Citation
Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853. Erratum In: JAMA. 2004 Nov 24;292(20):2470.
Results Reference
background
PubMed Identifier
11022069
Citation
Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. doi: 10.1161/01.str.31.10.2390. Erratum In: Stroke. 2007 May;38(5):e22.
Results Reference
background
PubMed Identifier
10661755
Citation
Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37. doi: 10.1080/096382800297097.
Results Reference
background
Links:
URL
http://fescenter.org/index.php
Description
Cleveland FES Center

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Treatments for Recovery of Hand Function in Acute Stroke Survivors

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