Stroke, Upper Extremity Hemiplegia
Conditions
Keywords
stroke, rehabilitation, Hemiplegia
Brief summary
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients
Detailed description
A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.
Interventions
DEVICEContralaterally Controlled Functional Electrical Stimulation (CCFES)
The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. uses surface electrodes over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove.
DEVICEHand Therapy Video Games
The use of video games with CCFES to encourage therapeutic hand movement at home
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-\> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke * age 21-80 years old * unilateral upper limb hemiparesis with finger extensor strength of grade \<=4/5 on the Medical Research Council (MRC) scale AND a score of \>=1 and \<=11/14 on the hand section of the upper extremity Fugl-Meyer Assessment * adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions) * able to follow 3-stage commands * able to recall 2 of 3 words after 30 minutes * surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening) * Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects * intact vision and hearing * medically stable * full voluntary opening/closing of the contralateral (less affected) hand * demonstrate ability to follow instructions for operating the stimulator or have a caregiver who will assist them
Exclusion criteria
* co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis * uncontrolled seizure disorder * severely impaired cognition and communication * uncompensated hemineglect * arm or forearm skin breakdown or edema (to avoid edema-related shunting of current) * insensate forearm (to avoid risk of electrical burns) * history of potentially fatal cardiac arrhythmias with hemodynamic instability * implanted electronic systems (e.g. pacemaker) * botulinum toxin injections to any upper extremity muscle within 3 months of enrolling * pregnant women due to unknown risks of surface stimulation during pregnancy * participating in occupational therapy or other rehabilitation therapies to the upper extremity * severe shoulder or hand pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test Score | 0 weeks,12 weeks, 36 weeks | The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) Score | 0 weeks, 12 weeks, 36 weeks | The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CCFES Video Game Therapy Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove.
The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. | 27 |
| CCFES Therapy Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove.
The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. | 25 |
| Total | 52 |
Baseline characteristics
| Characteristic | CCFES Video Game Therapy | Total | CCFES Therapy |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 11 | 61 years STANDARD_DEVIATION 10 | 62 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 22 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 18 Participants | 33 Participants | 15 Participants |
| Years Since Stroke | 5 years STANDARD_DEVIATION 4.5 | 4.5 years STANDARD_DEVIATION 4 | 3.9 years STANDARD_DEVIATION 3.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 8 / 27 | 7 / 25 |
| serious Total, serious adverse events | 3 / 27 | 2 / 25 |
Outcome results
Primary
Box and Block Test Score
The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
Time frame: 0 weeks,12 weeks, 36 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CCFES Video Game Therapy | Box and Block Test Score | 0 weeks | 10.6 blocks | Standard Error 2.6 |
| CCFES Video Game Therapy | Box and Block Test Score | 12 weeks | 11.2 blocks | Standard Error 2.8 |
| CCFES Video Game Therapy | Box and Block Test Score | 36 weeks | 11.1 blocks | Standard Error 2.7 |
| CCFES Therapy | Box and Block Test Score | 0 weeks | 11.0 blocks | Standard Error 2.6 |
| CCFES Therapy | Box and Block Test Score | 12 weeks | 12.4 blocks | Standard Error 2.8 |
| CCFES Therapy | Box and Block Test Score | 36 weeks | 11.6 blocks | Standard Error 2.6 |
Secondary
Action Research Arm Test (ARAT) Score
The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional)
Time frame: 0 weeks, 12 weeks, 36 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CCFES Video Game Therapy | Action Research Arm Test (ARAT) Score | 0 weeks | 19.4 units on a scale | Standard Error 3.6 |
| CCFES Video Game Therapy | Action Research Arm Test (ARAT) Score | 12 weeks | 18.6 units on a scale | Standard Error 3.5 |
| CCFES Video Game Therapy | Action Research Arm Test (ARAT) Score | 36 weeks | 18.8 units on a scale | Standard Error 3.7 |
| CCFES Therapy | Action Research Arm Test (ARAT) Score | 0 weeks | 19.0 units on a scale | Standard Error 2.6 |
| CCFES Therapy | Action Research Arm Test (ARAT) Score | 12 weeks | 21.2 units on a scale | Standard Error 2.8 |
| CCFES Therapy | Action Research Arm Test (ARAT) Score | 36 weeks | 20.6 units on a scale | Standard Error 2.8 |