Altering Activation Patterns Post-stroke

Recruiting

Phase N/A Results N/A

Update History

16 Jun '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3) - Single stroke occurring at least 6 months prior to enrollment - Spasticity - Capacity to provide informed consent Exclusion Criteria: - Excessive pain in paretic upper limb - Hemispatial neglect (as assessed by the Behavioral Inattention Test) - Apraxia (as assessed by the FABERS battery) - Botulinum toxin injection in the upper extremity within the past 6 months - Introduction of new anti-spasticity medication within the past 6 months - Orthopaedic impairments - History of seizure disorder - Other major health impairment
Old
Inclusion Criteria: - Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3) - Single stroke occurring at least 6 months prior to enrollment - Spasticity - Capacity to provide informed consent Exclusion Criteria: - Excessive pain in paretic upper limb - Hemispatial neglect (as assessed by the Behavioral Inattention Test) - Apraxia (as assessed by the FABERS battery) - Botulinum toxin injection in the upper extremity within the past 6 months - Introduction of new anti-spasticity medication within the past 6 months - Orthopaedic impairments - Other major health impairment
18 Jun '16
The eligibility criteria were updated.
New
Inclusion Criteria: - Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3) - Single stroke occurring at least 6 months prior to enrollment - Spasticity - Capacity to provide informed consent Exclusion Criteria: - Excessive pain in paretic upper limb - Hemispatial neglect (as assessed by the Behavioral Inattention Test) - Apraxia (as assessed by the FABERS battery) - Botulinum toxin injection in the upper extremity within the past 6 months - Introduction of new anti-spasticity medication within the past 6 months - Orthopaedic impairments - Other major health impairment
Old
Inclusion Criteria: - Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3) - Single stroke occurring at least 6 months prior to enrollment - Spasticity - Capacity to provide informed consent Exclusion Criteria: - Excessive pain in paretic upper limb - Hemispatial neglect (as assessed by the Behavourial Inattention Test) - Apraxia (as assessed by the FABERS battery) - Botulinum toxin injection in the upper extremity within the past 6 months - Introduction of new anti-spasticity medication within the past 6 months - Orthopaedic impairments - Other major health impairment
9 Jun '16
The description was updated.
New
In this four arm parallel design you will be randomly assigned to one of 4 groups: Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching. The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor. Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke. During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week. The investigators hypothesize that the group receiving the combined cyproheptadine and active movement therapy will have better outcomes than the groups receiving cyproheptadine or active movement therapy alone.
Old
In this four arm parallel design you will be randomly assigned to one of 4 groups: Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching. The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor. Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke. During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week. The investigators hypothesize that the group receiving the combined cyproheptadine and active movement therapy will have better outcomes than the groups receiving cyproheptadine or active movement therapy alone.
A location was updated in Chicago.
New
The overall status was updated to "Recruiting" at Rehabilitation Institute of Chicago.