NCT Number: NCT02850042
Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery
This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke
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Notify MeKey information
Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
The purpose of this study is to investigate change in motor performance and the extent of neuroplastic change associated with both occupation-based intervention and modified constraint-Induced therapy (m-CIT) in the recovery of upper extremity motor function following a stroke. Transcranial Magnetic Imaging (TMS) will be used to compare the difference in the brain reorganization of each client before and after the intervention to identify which technique is more effective in changing brain function. Central Hypothesis: Stroke subjects with motor deficit receiving occupation-based interventions will demonstrate improved motor function greater to that of the subjects receiving m-CIT interventions. Sixteen participants with chronic stroke will be recruited for the study over the age 21. Participants will be randomly assigned to one of the two therapy groups and will receive 55 minutes of therapy 2 times per week for 4 weeks for a total of 8 sessions.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 21 years of age and older
- at least 12 months from stroke
- mild-to-severe upper extremity motor deficit
- single ischemic or hemorrhagic stroke
Exclusion criteria
- history of head injury with loss of consciousness
- seizures
- severe alcohol or drug abuse
- psychiatric illness interfering with participation in the study including uncontrolled depression
- cognitive deficits severe enough to preclude informed consent
- ferromagnetic material near the brain
- individuals that could be pregnant
- cardiac or neural pacemakers
- if currently receiving occupational therapy services
Treatment and study plan
Modified-constraint induced therapy (m-CIT)
BehavioralPrimary outcomes
-
Fugl Meyer Assessment (FMA
Time frame: Score change after 8 days of intervention compared to baseline
Secondary outcomes
-
Stroke Impact Scale (SIS)
Time frame: Score change after 8 days of intervention compared to baseline
-
Canadian Occupational Performance Measure (COPM)
Time frame: Score change after 8 days of intervention compared to baseline
-
Goal Attainment Scale (GAS).
Time frame: Score change after 8 days of intervention compared to baseline
-
Transcranial Magnetic Stimulation (map volume)
Time frame: Score change after 8 days of intervention compared to baseline
Sponsors and collaborators
Lead sponsor
Lumy Sawaki
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 29, 2016
- Registry last updated
- Apr 20, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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