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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


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.


Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

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