Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: High Intensity 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
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.
Other Names:
|
Active Comparator: Low Intensity 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
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.
Other Names:
|
Active Comparator: Control Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Box and Block Test; Data Collected = Number of Blocks Moved [Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)]
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 [Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)]
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 [Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Motor Behavior Laboratory, University of Florida | Gainesville | Florida | United States | 32611 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: James H. Cauraugh, Ph.D., University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
- 00061194
Study Results
Participant Flow
Recruitment Details | Started August 2006 and ended June 2009 |
---|---|
Pre-assignment Detail | Inability to voluntarily execute 10 degrees of wrist/finger extension from a 60-65 degrees flexed position. |
Arm/Group Title | High Intensity | Low Intensity | Control |
---|---|---|---|
Arm/Group 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. |
Period Title: Overall Study | |||
STARTED | 10 | 10 | 10 |
COMPLETED | 6 | 5 | 3 |
NOT COMPLETED | 4 | 5 | 7 |
Baseline Characteristics
Arm/Group Title | High Intensity | Low Intensity | Control | Total |
---|---|---|---|---|
Arm/Group 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. | Total of all reporting groups |
Overall Participants | 10 | 10 | 10 | 30 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
4
40%
|
3
30%
|
5
50%
|
12
40%
|
>=65 years |
6
60%
|
7
70%
|
5
50%
|
18
60%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
65.3
(8.1)
|
67.2
(6.8)
|
61.8
(2.6)
|
65.2
(6.6)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
6
60%
|
6
60%
|
5
50%
|
17
56.7%
|
Male |
4
40%
|
4
40%
|
5
50%
|
13
43.3%
|
Region of Enrollment (participants) [Number] | ||||
United States |
10
100%
|
10
100%
|
10
100%
|
30
100%
|
Outcome Measures
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) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment. |
Arm/Group Title | High Intensity | Low Intensity | Control |
---|---|---|---|
Arm/Group 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 |
Measure Participants | 6 | 5 | 3 |
Baseline/Pretest |
24.5
(22.1)
|
24.6
(12.7)
|
40
(27.1)
|
Posttest |
27.5
(21.7)
|
31.8
(12.6)
|
42
(26.5)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | High Intensity, Low Intensity, Control |
---|---|---|
Comments | Group by Test Session ANOVA with repeated measures on second factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.05 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | Greenhouse-Geisser degrees of freedom adjustment was not necessary. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 30 | |
Confidence Interval |
(2-Sided) 95% 22.5 to 37.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.65 |
|
Estimation Comments |
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) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment. |
Arm/Group Title | High Intensity | Low Intensity | Control |
---|---|---|---|
Arm/Group Description | Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks. | Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks. | Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks. |
Measure Participants | 6 | 5 | 3 |
Baseline/Pretest |
39
(19.8)
|
41
(16.3)
|
53
(9.7)
|
Posttest |
42
(17.1)
|
45
(15.6)
|
56
(6.9)
|
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) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment. |
Arm/Group Title | High Intensity | Low Intensity | Control |
---|---|---|---|
Arm/Group 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 |
Measure Participants | 6 | 5 | 3 |
Baseline/Pretest |
179
(27.1)
|
225
(19.3)
|
135
(5.6)
|
Posttest |
170
(22.8)
|
241
(23.4)
|
161
(5.4)
|
Adverse Events
Time Frame | 2 years, 10 months | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | High Intensity | Low Intensity | Control | |||
Arm/Group 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. | |||
All Cause Mortality |
||||||
High Intensity | Low Intensity | Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
High Intensity | Low Intensity | Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
High Intensity | Low Intensity | Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | James Cauraugh, Ph.D., PI |
---|---|
Organization | University of Florida, Motor Behavior Laboratory |
Phone | 352-294-1623 |
jcaura@hhp.ufl.edu |
- 00061194