Clinical Trial: Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial
Brief Summary: Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.
Detailed Summary:
Study design:
Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.
Eligibility criteria:
Inclusion criteria:
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
- Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.
Exclusion criteria:
- Hemorrhagic strokes
- Patient's with an episode
Sponsor: University of Oklahoma
Current Primary Outcome: Total Functional Independence Measure (TFIM) Change Scores [ Time Frame: from baseline to 4-weeks of therapy ]
The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.
Original Primary Outcome: total Functional Independence Measure (TFIM) [ Time Frame: after 4-weeks of therapy ]
The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.
Current Secondary Outcome:
- Action Research Arm Test (ARAT) Change Scores [ Time Frame: baseline to after 4-weeks of therapy ]The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal
- Discharge Disposition [ Time Frame: after 4 weeks of intervention ]Patient discharged home or to sub-acute facility
Original Secondary Outcome: Action Research Arm Test (ARAT) [ Time Frame: after 4-weeks of therapy ]
The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually
Information By: University of Oklahoma
Dates:
Date Received: September 7, 2010
Date Started: September 16, 2010
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017
- Action Research Arm Test (ARAT) Change Scores [ Time Frame: baseline to after 4-weeks of therapy ]