Altering Activation Patterns Post-stroke
Information source: Rehabilitation Institute of Chicago
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke; Muscle Spasticity; Hemiparesis
Intervention: Cyproheptadine (Drug); Placebo for Cyproheptadine (Drug); Active Movement Practice (AMP) (Other); Passive Cyclical Stretching (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Rehabilitation Institute of Chicago Official(s) and/or principal investigator(s): Derek G Kamper, PhD, Principal Investigator, Affiliation: Illinois Institute of Technology / Rehabilitation Institute of Chicago
Overall contact: Kristen M Triandafilou, MS, Phone: 312-238-2993, Email: triandafilou@ricres.org
Summary
This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase
of recovery in which the combination of drug therapy (cyproheptadine) and active movement
practice (AMP) is used to encourage increased voluntary muscle control and strength.
Clinical Details
Official title: Altering Activation Patterns in the Distal Upper Extremity After Stroke
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in mean completion time for Graded Wolf Motor Function Test (GWMFT)
Secondary outcome: Change in grip relaxation time (Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.)
Detailed description:
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kristen M Triandafilou, MS, Phone: 312-238-2993, Email: triandafilou@ricres.org
Rehabilitation Institute of Chicago, Chicago, Illinois 60611, United States
Additional Information
Related publications: Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382. Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.
Starting date: September 2015
Last updated: April 13, 2015
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