Altering Activation Patterns Post-stroke

NAActive, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

August 31, 2019

Study Completion Date

December 31, 2023

Conditions
StrokeMuscle SpasticityHemiparesis
Interventions
DRUG

Cyproheptadine

"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug"

DRUG

Placebo for Cyproheptadine

"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug"

OTHER

Active Movement Practice (AMP)

Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.

OTHER

Passive Cyclical Stretching

Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.

Trial Locations (1)

60611

Rehabilitation Institute of Chicago, Chicago

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Shirley Ryan AbilityLab

OTHER

NCT02418949 - Altering Activation Patterns Post-stroke | Biotech Hunter | Biotech Hunter