Comparing Prism Adaptation Training With and Without TENS to Minimize Unilateral Spatial Neglect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKettering Health Network
About this trial
This study aims to find out if doing two treatments together-Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS)-will help people who have had a stroke pay better attention to one side of their body, better than just doing PAT by itself.
In addition to understanding how the intervention improves function the investigators would like to see if things like how old someone is, how long ago their stroke happened, where their brain was damaged, or how bad the neglect is, affect how well the treatment works.
To measure if the interventions make a difference the following outcome measures will be used.
Catherine Bergego Scale (CBS):
This is a test to see how severe someone's neglect is. Trained therapists use 10 simple tasks to check if a person is ignoring the left or right side.
Wolf Motor Function Test (WMFT):
This test checks how well a stroke survivor can move their arm. It helps the therapists see if the treatments improve movement and reaction time
People can join the study if they had a stroke, score at least "1" on the Catherine Bergego Scale, and they can understand and agree to take part in the study.
People cannot join the study if they have had more than two strokes, have or had seizures, or have a serious mental illness like schizophrenia, or have cancer in the arm that was affected by the stroke, they have a pacemaker or defibrillator in their body, and if they can't feel their arm on the side affected by the stroke
Once the study is done, the main results will be shared with the therapists who work at the NeuroRehab and Balance Center, like the physical, speech, and occupational therapists.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A diagnosis of stroke
Score 1 or above on the Catherine Bergego Scale
Cognitively able to consent
Disqualifiers
Seizure disorder
Diagnosed with more than two strokes
Diagnosis of schizophrenia or schizoaffective disorder
Cancer diagnosis of upper extremity
Trial design
Design model
Parallel
Treatments tested in this trial
Prism adaptation training combined with TENS
DeviceSubjects in the experimental group will receive both prism adaptation training and TENS to identify affects on USN. To date there are no published studies combining these treatments to minimize USN.
PAT only
Other interventionSubjects will receive prism adaptation training (PAT) only wearing prism goggles during a functional reaching task during occupational therapy.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PAT + TENS treatmentExperimental treatment 1 intervention
Group B: PAT onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in unilateral spatial neglect functional deficits
The Catherine Bergego Scale (CBS) is the selected outcome measure for assessing the severity of Unilateral Spatial Neglect (USN) and for evaluating changes in function and neglect following interventions. The CBS includes 10 subtests designed to identify both the presence and severity of USN. Maximum score on the CBS is 30 which indicates severe neglect, minumum score is 0 which indicates no neglect.
Time frame
From enrollment to discharge from therapy services which is typically 8-12 weeks2
Change in motor control deficits
The Wolf Motor Function Test (WMFT) is a standardized assessment tool widely used to measure upper extremity motor abilities in individuals recovering from a stroke. This test serves as an outcome measure for motor control, assessing motor ability via a performance time and a Functional Ability Scale (FAS) of 15 subtests. During the timed tests subjects are allowed a maximum of 120 seconds per task. If a person cannot complete the task within 120 seconds the time is recorded as 120+. The official WFMT time score is the median time of 15 timed tasks. The FAS is calculated using a 6-point ordinal scale from 0-5. A higher score indicates better movement (0 = does not attempt to use the affected limb to 5=movement appears normal). The FAS score is calculated by averaging scores across all subtests.
Time frame
From time of enrollment to discharge from therapy services typically 8-12 weeksSponsors and contacts
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Source ClinicalTrials.gov